diff --git "a/M7_Train.csv" "b/M7_Train.csv" deleted file mode 100644--- "a/M7_Train.csv" +++ /dev/null @@ -1,911 +0,0 @@ -prompt,id,instruction,output,Train -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05052801,"{Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ?10% 2+/3+ tumor cell staining (FGFR2b ?10% 2+/3+TC)', 'Condition': 'Gastric Cancer\nGastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nAdults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\nFibroblast growth factor receptor 2b (FGFR2b) ?10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\nEastern Cooperative Oncology Group (ECOG) less than or equal to 1\nMeasurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\nParticipant has no contraindications to mFOLFOX6 chemotherapy\nAdequate organ and bone marrow function:\n\nabsolute neutrophil count greater than or equal to 1.5 times 10^9/L\nplatelet count greater than or equal to 100 times 10^9/L\nhemoglobin ? 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\naspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\ncalculated or measured creatinine clearance (CrCl) of ? 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) � Mass [kg]/[72 � Creatinine mg/dL]) (x 0.85 if female)\ninternational normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment""}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05052801,"{Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ?10% 2+/3+ tumor cell staining (FGFR2b ?10% 2+/3+TC)', 'Condition': 'Gastric Cancer\nGastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nAdults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\nFibroblast growth factor receptor 2b (FGFR2b) ?10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\nEastern Cooperative Oncology Group (ECOG) less than or equal to 1\nMeasurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\nParticipant has no contraindications to mFOLFOX6 chemotherapy\nAdequate organ and bone marrow function:\n\nabsolute neutrophil count greater than or equal to 1.5 times 10^9/L\nplatelet count greater than or equal to 100 times 10^9/L\nhemoglobin ? 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\naspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\ncalculated or measured creatinine clearance (CrCl) of ? 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) � Mass [kg]/[72 � Creatinine mg/dL]) (x 0.85 if female)\ninternational normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment""}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05029102,"{Official Title': 'TAS-102 Combined With Anlotinib in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments (THALIA): a Prospective Single-arm Phase II Study', 'Brief Summary': 'To determine the efficacy and safety of TAS-102 and Anlotinib in patients with metastatic gastric cancer who had been treated with ? 2 lines of prior standard chemotherapy', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAge ? 18 years, ?75 years\r\nHistologically confirmed gastric cancer with distant metastasis\r\nECOG 0-1\r\nProgression on ? 2 lines of prior standard chemotherapy\r\nPatients can swallow pills normally\r\nExpected overall survival ?6 months\r\nBlood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts > 3000/�l?Absolute neutrophil count (ANC) ? 1500 cells/�l?Platelet count ? 100,000/�l?Hemoglobin ? 9.0 g/dL.\r\nAST, ALT and alkaline phosphatase ? 2.5 times the upper limit of normal (ULN)?Serum bilirubin ? 1.5 x ULN?creatinine 30kg.\nHistologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).\nKnown MSS/MSI status or tumor tissue available (frozen or paraffin-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.\nFailure to platinium-based 1st line therapy with or without trastuzumab, or early recurrent disease after surgery with neo-adjuvant and/or adjuvant platinium-based chemotherapy (within 6 months of the end of chemotherapy) or progression during neo-adjuvant and/or adjuvant platinium-based chemotherapy.\nEligible for a second-line treatment with irinotecan and 5-FU.\nMeasurable or non-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\nEastern Cooperative Oncology Group (ECOG) performance status 0-1.\nAdequate organ function: ANC ? 1.5 x 109/L, haemoglobin ? 9 g/dL, platelets ? 100 x 109/L, AST/ALT ? 3 x ULN (? 5 x ULN in case of liver metastase(s)), GGT ? 3 x ULN (? 5 x ULN in case of liver metastase(s)), bilirubin ? 1.5 x ULN, creatinin clearance > 40 mL/min (MDRD).\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\nMan and woman who childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\nPatient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.'}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03959293,"{Official Title': 'A Randomized Phase II Study Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma\n', 'Brief Summary': 'Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone).\n\nSecond-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012).\n\nBased on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) � ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Condition': 'Gastric Adenocarcinoma\nGastric Cancer', 'Detailed Description': 'Gastric adenocarcinoma is the fourth most frequent cancer and the second leading cause of cancer mortality. Advanced gastric adenocarcinoma has a poor prognosis with short overall survival (ranging from 10% to 15% at 5-years) even after surgical complete resection and despite the progress in therapeutic approaches. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone). First-line chemotherapy depends on HER2 status, which also influenced overall survival (14 months for HER2 positive versus 10 months for HER2 negative tumors). In HER2 negative tumors standard first-line regimen is a doublet of fluoropyrimidine (5-fluorouracil or capecitabine) plus a platinum salt (cisplatin or oxaliplatin). 5-fluorouracil (5-FU) and capecitabine as also cisplatin and oxaliplatin have similar efficacy but different toxicities.\n\nIn patients whose tumor overexpresses the HER2 receptor adding trastuzumab to fluoropyrimidine/cisplatin regimen increased overall survival compared to chemotherapy alone. In HER2 negative tumors the addition of docetaxel to cisplatin/fluoropyrimidine regimen increased overall survival but its use remains limited in clinical practice because of its high toxicity. Preliminary results demonstrated a high efficacy with less toxicities of docetaxel-oxaliplatin-fluoropyrimidine combination, also called TFOX/FLOT regimen. Indeed, in France a large phase III trial comparing TFOX versus FOLFOX in first-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma is ongoing (GASTFOX, trial NCT03006432). Primary endpoint is progression-free survival (PFS) and 506 patients are planned between 2017 and 2020 (actually at the date of January 30, 2018, 65 patients are included).\n\nSecond-line chemotherapy improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Weekly paclitaxel monotherapy is also used because of its good efficacy-toxicity ratio. Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012). Recently ramucirumab monotherapy demonstrated its efficacy on overall survival in a randomized, placebo-controlled second-line metastatic study. In a randomized phase 3 trial ramucirumab also showed its efficacy in combination with paclitaxel versus paclitaxel monotherapy with a median overall survival of 9.6 versus 7.4 months, respectively (p=0.017; HR=0.81). However, the ""amelioration du service medical rendu"" (ASMR) assessed by the French ""Haute Autorit� de Sant�"" (HAS) consider an insufficient benefit to a reimbursement of ramucirumab in France. The HAS gave a moderate ASMR opinion (ASMR IV).\n\nDocetaxel is more and more frequently used in first-line chemotherapy then in this setting taxane (alone or combined with others drugs) cannot be used as second-line regimen. Indeed, based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nHuman tumors tend to activate the immune system regulatory checkpoints as a means of escaping immunosurveillance. For instance, interaction between PD1 (Program Death 1) and PD-L1 (Program Death 1 ligand) will lead the activated T cell to a state of anergy. PD-L1 is up regulated on a wide range of cancers. Anti-PD1 and anti-PD-L1 monoclonal antibodies (mAbs), called immune checkpoint inhibitors (ICIs), have consequently been designed to restore T cell activity. Others ICIs are investigated, notably cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors. CTLA-4 transmits an inhibitory signal to T cells to prevent early excessive T cell activation. CTLA4 blockade may stimulate a more robust antitumor response by sustaining activation and proliferation of T lymphocytes and may overcome immune suppression mediated by regulatory T cells. ICIs have been recently tested in many cancers with promising results, especially in tumors with microsatellite instability (MSI) and/or PD-L1 overexpression.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) � ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. Finally, immunogenic cell death induced by chemotherapy may enhance efficacy of ICIs. Durvalumab (MEDI4736) is a human monoclonal antibody directed against PD-L1 in development for the treatment of many cancers. A phase I study included 16 patients with advanced gastric cancer and the objective response rate was 25%. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Durvalumab plus tremelimumab combination showed a manageable tolerability profile, with antitumour activity irrespective of PD-L1 status in non-small cell lung cancer (NSCLC). Durvalumab alone or combined with tremelimumab is evaluated in phase III studies in NSCLC (e.g NEPTUNE and MYSTIC), small cell lung cancer (CASPIAN), hepatocellular carcinoma (HIMALAYA), bladder cancer (DANUBE) and head and neck cancer (EAGLE and KESTREL).\n\nConcerning safety of anti-PD1 plus anti-CTLA4 combination, in the randomized phase I/II CheckMate-032 study, that included 160 patients, there was no unexpected toxicity signal. Grade 3 and 4 treatment-related adverse events were 17%, 47%, and 27%, respectively. These rates of grade 3 and 4 treatment-related adverse events are those usually found with the anti-PD1 plus anti-CTLA4 combination in other tumors, observed approximately in 40% of patients. Up until now, there is no published data concerning combination of ICIs plus irinotecan. Nevertheless, in all trial combining chemotherapy plus anti-PD1 and/or anti-CTLA4 chemotherapy drugs were used at full-dose (5FU, oxaliplatin, cisplatin�). An Italian trial just started and combined full-dose FOLFOXIRI (5-FU 3200 mg/m2 plus irinotecan 165 mg/m2 and oxaliplatin 85 mg/m2) with bevacizumab (5 mg/kg) and atezolizumab (anti-PD-L1, 840 mg) in metastatic colorectal cancers as first-line treatment. FOLFOXIRI is a triplet chemotherapy more ""toxic"" than FOLFIRI doublet chemotherapy and this trial is a randomized phase II (FOLFOXIRI plus bevacizumab and atezolizumab versus FOLFOXIRI plus bevacizumab). There is, however, a preliminary safety phase in 6 patients, once they have all received at least 2 cycles of treatment, the latter being administered at full dose (AtezoTRIBE trial, NCT03721653).\n\nThe present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ? 18 years.\nBody weight > 30kg.\nHistologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).\nKnown MSS/MSI status or tumor tissue available (frozen or paraffin-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.\nFailure to platinium-based 1st line therapy with or without trastuzumab, or early recurrent disease after surgery with neo-adjuvant and/or adjuvant platinium-based chemotherapy (within 6 months of the end of chemotherapy) or progression during neo-adjuvant and/or adjuvant platinium-based chemotherapy.\nEligible for a second-line treatment with irinotecan and 5-FU.\nMeasurable or non-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\nEastern Cooperative Oncology Group (ECOG) performance status 0-1.\nAdequate organ function: ANC ? 1.5 x 109/L, haemoglobin ? 9 g/dL, platelets ? 100 x 109/L, AST/ALT ? 3 x ULN (? 5 x ULN in case of liver metastase(s)), GGT ? 3 x ULN (? 5 x ULN in case of liver metastase(s)), bilirubin ? 1.5 x ULN, creatinin clearance > 40 mL/min (MDRD).\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\nMan and woman who childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\nPatient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.'}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03863483,"{Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVolunteer to participate in clinical research; fully understand and know the research and sign informed consent;\r\nAge ? 18 years old and ? 75 years old, either sex;\r\nEastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;\r\nHas a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;\r\nHave at least one measurable lesion as defined by RECIST 1.1;\r\nHas progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;\r\nPatients without activating EGFR mutation;\r\nNormal hepatic function: total bilirubin?1.5�normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ?2.5�ULN or ?5�ULN if liver metastasis is present;\r\nNormal renal function: Creatinine ?1.5�ULN or calculated creatinine clearance ?45 mL/min (using Cockcroft/Gault formula to calculate );\r\nNormal hematological function: absolute neutrophil count ?1.5�109/L, platelet count ?70�109/L, hemoglobin?80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];\r\nHas a life expectancy of at ?3 months.'}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03863483,"{Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVolunteer to participate in clinical research; fully understand and know the research and sign informed consent;\r\nAge ? 18 years old and ? 75 years old, either sex;\r\nEastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;\r\nHas a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;\r\nHave at least one measurable lesion as defined by RECIST 1.1;\r\nHas progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;\r\nPatients without activating EGFR mutation;\r\nNormal hepatic function: total bilirubin?1.5�normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ?2.5�ULN or ?5�ULN if liver metastasis is present;\r\nNormal renal function: Creatinine ?1.5�ULN or calculated creatinine clearance ?45 mL/min (using Cockcroft/Gault formula to calculate );\r\nNormal hematological function: absolute neutrophil count ?1.5�109/L, platelet count ?70�109/L, hemoglobin?80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];\r\nHas a life expectancy of at ?3 months.'}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05179239,"{Official Title': 'A Randomized?Double-blind?Controlled?Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ? 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05179239,"{Official Title': 'A Randomized?Double-blind?Controlled?Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ? 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05179239,"{Official Title': 'A Randomized?Double-blind?Controlled?Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ? 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04732494,"{Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ? 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ? 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.\nHave PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\nHave measurable disease as assessed by RECIST v1.1.\nHave confirmed PD-L1 TAP ? 10% in tumor tissues tested by the central lab.\nEastern Cooperative Oncology Group Performance Status score of 0 or 1.'}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04732494,"{Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ? 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ? 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.\nHave PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\nHave measurable disease as assessed by RECIST v1.1.\nHave confirmed PD-L1 TAP ? 10% in tumor tissues tested by the central lab.\nEastern Cooperative Oncology Group Performance Status score of 0 or 1.'}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05299255,"{Official Title': 'An Open, Single-center Phase II Clinical Study of Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer', 'Brief Summary': 'SCLC has a very high degree of malignancy, and 60% to 70% of patients are diagnosed as extensive stage. The median survival of patients with limited-stage disease is about 15-20 months, and the median OS of patients with extensive-stage disease is about 8-13 months, and the 2-year and 5-year survival rates are about 5% and 1-2%, respectively. However, although the initial treatment has a high effective rate, most patients relapse or progress within 1 year, and the effect of re-treatment is poor and the prognosis is poor. The effective rate of SCLC second-line treatment is only 10-25%, and the median survival time is less than 6 months. After the third and fourth lines, there are almost no recognized treatment options. Therefore, improving the second-line treatment of SCLC has always been a difficult clinical problem, and new drugs are urgently needed to be explored. In small cell lung cancer, based on phase II clinical trials, paclitaxel is currently recommended by NCCN guidelines for subsequent systemic therapy in patients who relapse 6 months or less after initial therapy. Utidelone (UTD1) is an epothilone derivative with a similar mechanism of action to taxanes, but a completely different molecular structure.', 'Condition': 'SCLC, Extensive Stage', 'Detailed Description': 'Compared with paclitaxel, epothilones has higher water solubility and toxicity tolerance, and fewer side effects, these findings suggest that utidron may have better antitumor activity against small cell lung cancer. Therefore, to prospectively observe the treatment of extensive-stage small cell lung cancer with failure of second-line or above chemotherapy and receive Utilidron, so as to understand the efficacy, safety and tolerability of Utilidron in the third-line and above treatment of small cell lung cancer, which is a small Post-line treatment of cell lung cancer provides new directions and treatment options.\n\nThis study is an open, single-center phase II clinical study. Small cell lung cancer patients with disease progression or recurrence after second-line therapy or above, receive Utilidron injection. Utilidron injection 40mg/m2/d d1-5 q3w was administered until disease progression (PD), intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, and the investigator decided to be tested Subjects who withdraw from the study treatment or the subject/their legal representative requests to withdraw from the study (whichever occurs first). After consultation with the sponsor, the patient will determine whether the treatment can be continued, observe and evaluate the preliminary efficacy and safety.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically diagnosed small cell lung cancer (except for small cell lung cancer mixed with other pathological types);\nThe expected survival period is not less than 3 months;\nSecond-line therapy (excluding maintenance therapy) and above with disease progression or recurrence of small cell lung cancer;\nPatients who have not received chemotherapy, radiotherapy, surgery, targeted therapy and immunotherapy within 4 weeks before enrollment;\nAge 18-75 years old, physical condition score ECOG 0-1 points;\nAt least one target lesion measurable by imaging within 3 weeks before enrollment, ordinary CT scan ? 20 mm, spiral CT scan diameter ? 10 mm (lymph node short diameter ? 15 mm);\nAsymptomatic brain metastases, or patients with stable disease for more than 4 weeks after brain metastases treatment;\nNeurological lesions should be less than grade 2 within 4 weeks before enrollment (NCI CTC4.03);\nRoutine blood and blood biochemical tests were basically normal within 1 week before enrollment (based on the normal value of the research center laboratory, no blood transfusion within 14 days before screening, and no rhG-CSF was used):\nBlood routine: HGB?9g/dL; ANC?1.5�109/L; PLT?80�109/L; Blood biochemistry (without ALB infusion within 14 days): bilirubin <1.5 times the upper limit of normal, ALT and AST ?2.5 times the upper limit of normal (if liver metastases exist, bilirubin ?3 times the upper limit of normal, ALT and AST?3 times the upper limit of normal) 5 times the upper limit of normal), serum Cr?1.5 times the upper limit of normal or endogenous creatinine clearance ?45 mL/min (Cockcroft-Gault formula);\n\nThose who have no major organ dysfunction and no concomitant heart disease;\nFemales of childbearing age, including those who are in menopause but have not reached postmenopausal state (natural amenorrhea for 12 consecutive months) and who have not received sterilization and ovarian and/or hysterectomy, must have a blood pregnancy test within 7 days before the first'}",{'Arm - Disease - Line of Therapy': 'Third-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03740165,"{Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]?10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS?10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': ""Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03740165,"{Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]?10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS?10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': ""Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03740165,"{Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]?10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS?10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': ""Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05580562,"{Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ? 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ? 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ? 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ? 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid).""}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04853043,"{Official Title': 'APK Mutant: A Single Arm Phase II Study of Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'A prospective, multi-center, phase II study of 21 patients to evaluate the efficacy of the EGFR inhibitor, Cetuximab in patients with mCRC harboring APC, TP53 and RAS mutations.', 'Condition': 'Colorectal Cancer', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nMale or female subject aged ? 18 years.\nHistologically confirmed metastatic colorectal adenocarcinoma with mutant APC, TP53 and KRAS genes as determined by the local CLIA-certified laboratory are eligible. All RAS mutations are allowed (KRAS, NRAS, HRAS). Patients with wild type KRAS, APC or TP53 are ineligible..\nProgression or unwanted toxicities on atleast 2 prior lines of treatment including 5-Flourouracil, oxaliplatin and irinotecan based regimen\nStudy participants must have measurable disease by RECIST 1.1 criteria by CT or MRI.\nECOG Performance Status ? 2.\nStudy participants with treated and/or stable brain metastases are allowed\nStudy participants must have anticipated life expectancy > 3 months\nAdequate organ function as defined as:\n\nHematologic:\n\nAbsolute neutrophil count (ANC) ? ?1000/�L\nPlatelet count ? 100,000/mm3\nHemoglobin ? 9 g/dL\nHepatic:\n\nSerum Bilirubin ? 2 x ULN or ? 3 x ULN for subjects with Gilbert's syndrome\nAspartate transaminase (AST) and alanine transaminase (ALT) ? 3.0 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases)\nRenal:\n\nSerum creatinine ?1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ?40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)\nFor female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\nWomen < 50 years of age:\n\nAmenorrheic for ? 12 months following cessation of exogenous hormonal treatments; and\nLuteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\nUnderwent surgical sterilization (bilateral oophorectomy or hysterectomy).\nWomen ? 50 years of age:\n\nAmenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\nHad radiation-induced menopause with last menses >1 year ago; or\nHad chemotherapy-induced menopause with last menses >1 year ago; or\nUnderwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\nFemale subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for atleast 12 months after last study treatment administration.\nMale subjects must agree to use a condom during intercourse for the duration of study therapy and for atleast 12 months after last study treatment administration.\nRecovery to baseline or ? Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator.\nAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.""}",{'Arm - Disease - Line of Therapy': 'Third-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT02773524,"{Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)\n', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)\n', 'Condition': 'Gastro-Oesophageal Cancer\n', 'Detailed Description': 'Purpose:\n\nThe purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.\n\nWho is it for:\n\nYou may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.\n\nTrial Details:\n\nParticipants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria\n\nAdults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:\n\nhas arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and\nis of adenocarcinoma or undifferentiated carcinoma histology , and\nis evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and\nhas failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.\n\nNote: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.\n\nHER2-positive participants must have received trastuzumab.\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\nAbility to swallow oral medication.\nAdequate bone marrow function (Platelets ?100x109/L; Absolute Neutrophil Count (ANC) ?1.5x109/L and Haemoglobin ? 9.0g/dL).\nAdequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ?1.5 x Upper Limit of Normal (ULN).\nAdequate liver function (Serum total bilirubin ?1.5 x ULN, and INR ? 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ?2.5 x ULN (? 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.\nAdequate cardiac function (Left Ventricular Ejection Fraction (LVEF) ? 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy.\nWilling and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.\nStudy treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday).\nSigned, written informed consent.'}",{'Arm - Disease - Line of Therapy': 'Third Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT02773524,"{Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)\n', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)\n', 'Condition': 'Gastro-Oesophageal Cancer\n', 'Detailed Description': 'Purpose:\n\nThe purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.\n\nWho is it for:\n\nYou may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.\n\nTrial Details:\n\nParticipants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria\n\nAdults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:\n\nhas arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and\nis of adenocarcinoma or undifferentiated carcinoma histology , and\nis evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and\nhas failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.\n\nNote: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.\n\nHER2-positive participants must have received trastuzumab.\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\nAbility to swallow oral medication.\nAdequate bone marrow function (Platelets ?100x109/L; Absolute Neutrophil Count (ANC) ?1.5x109/L and Haemoglobin ? 9.0g/dL).\nAdequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ?1.5 x Upper Limit of Normal (ULN).\nAdequate liver function (Serum total bilirubin ?1.5 x ULN, and INR ? 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ?2.5 x ULN (? 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.\nAdequate cardiac function (Left Ventricular Ejection Fraction (LVEF) ? 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy.\nWilling and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.\nStudy treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday).\nSigned, written informed consent.'}",{'Arm - Disease - Line of Therapy': 'Third Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04322539,"{Official Title': 'A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.', 'Condition': 'Metastatic Colorectal Cancer, Metastatic Colon Cancer', 'Detailed Description': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate.\n\nMetastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nProvide written informed consent;\nAge ?18 years;\nHistologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;\nParticipants must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;\nParticipants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor;\nParticipants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;\nBody weight ?40kg;\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1;\nHave measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;\nExpected survival >12 weeks.\nFor female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom.\nParticipants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor.""}",{'Arm - Disease - Line of Therapy': 'Fourth-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04322539,"{Official Title': 'A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.', 'Condition': 'Metastatic Colorectal Cancer, Metastatic Colon Cancer', 'Detailed Description': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate.\n\nMetastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nProvide written informed consent;\nAge ?18 years;\nHistologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;\nParticipants must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;\nParticipants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor;\nParticipants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;\nBody weight ?40kg;\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1;\nHave measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;\nExpected survival >12 weeks.\nFor female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom.\nParticipants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor.""}",{'Arm - Disease - Line of Therapy': 'Fourth-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05920356,"{Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\r\nNo history of systemic anticancer therapy in metastatic/non-curable settings\r\nEastern Cooperative Oncology Group (ECOG) ? 1'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05920356,"{Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\r\nNo history of systemic anticancer therapy in metastatic/non-curable settings\r\nEastern Cooperative Oncology Group (ECOG) ? 1'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03912415,"{Official Title': 'An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer\n', 'Brief Summary': 'This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab\n', 'Condition': 'Cervical Cancer\n', 'Detailed Description': ""Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigning an IRB/EC-approved informed consent\nFemales ? 18 years of age on day of signing informed consent\nHistologically confirmed squamous carcinoma of the cervix\nProgressing thru or recurrent disease treated for curative intent or primary metastatic cervical cancer stage FIGO IVB\nAgreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (using archival biopsy material is only acceptable in subjects in whom obtaining a new sample is contraindicated)\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use a contraceptive method with a failure rate of < 1% per year from the moment of signing informed consent, during the treatment period and at least 6 months after administration of the last dose of study drug. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (? 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not acceptable method of contraception.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03912415,"{Official Title': 'An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer\n', 'Brief Summary': 'This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab\n', 'Condition': 'Cervical Cancer\n', 'Detailed Description': ""Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigning an IRB/EC-approved informed consent\nFemales ? 18 years of age on day of signing informed consent\nHistologically confirmed squamous carcinoma of the cervix\nProgressing thru or recurrent disease treated for curative intent or primary metastatic cervical cancer stage FIGO IVB\nAgreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (using archival biopsy material is only acceptable in subjects in whom obtaining a new sample is contraindicated)\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use a contraceptive method with a failure rate of < 1% per year from the moment of signing informed consent, during the treatment period and at least 6 months after administration of the last dose of study drug. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (? 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not acceptable method of contraception.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04526470,"{Official Title': 'Phase IB/II Study of Alpelisib in Combination With Paclitaxel in Patients With PIK3CA-altered Metastatic/Recurrent Gastric Cancer', 'Brief Summary': 'Alpelisib (BYL719) is a PIK3CA-specific inhibitor, which was developed by Novartis (Basel, Switzerland). Our group conducted pre-clinical study of alpelisib in eight gastric cancer cell lines: four PIK3CA wild-type (SNU638, SNU668, SNU1, and SNU16) and four PIK3CA mutant (SNU719, AGS, SNU601, and MKN). As a result, alpelisib preferentially inhibited the growth of gastric cancer cells with PIK3CA mutations. In addition, alpelisib inhibited cell growth via G1 arrest and subsequently induces apoptosis in GC cells, and this effect is more remarkable in cells harboring PIK3CA mutations. Moreover, alpelisib in combination with paclitaxel showed synergistic cytotoxic effects and significantly increased apoptosis compared with alpelisib or paclitaxel monotherapy in GC cells.\r\n\r\nThe purpose of the study is to define the maximal tolerated dose (MTD) and recommended phase II dose (RP2D) of paclitaxel and alpelisib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and AZD8186 combination therapy as a second-line therapy in patients with advanced gastric cancer with PTEN aberrations. This study is divided into Phase IB and Phase II.', 'Condition': 'Stomach Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSubject has signed the Informed Consent Form (ICF) prior to any screening procedures being performed\r\nAge ? 20 years old of male and female\r\nAt each phase of the trial, subjects who meet the following requirements in each phase will be enrolled.\r\n\r\nPhase IB: Subjects with a histologically-confirmed, advanced/recurrent solid tumor who have progressed on standard therapy or whose disease does not have established standard therapy.\r\nPhase II: Subjects with histologically confirmed locally advanced or metastatic gastric cancer that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy (Tissue samples of gastric cancer must contain PIK3CA gene alterations (e.g. single nucleotide variants, small indels, amplifications, structural variations, etc.) identified by central or local next generation sequencing (NGS). If the subject received adjuvant chemotherapy after curative gastric resection and lymph node dissection, the adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy.\r\nPhase IB: Patient has evaluable disease as per RECIST 1.1. (Measurable lesions are not mandatory for study inclusion.) Phase II: Patient has at least one measurable lesion as per RECIST 1.1.\r\nECOG performance status 0-1\r\nPatient has adequate bone marrow and organ function as defined by the following laboratory values:\r\n\r\nAbsolute neutrophil count (ANC) ? 1.5 x 109/L\r\nHemoglobin ? 9.0 g/dL\r\nPlatelet ? 100 x 109/L\r\nSerum creatinine ? ULN (upper limit of normal) or serum creatinine clearance ?50 mL/min (by Cockcroft-Gault formula, or 24h urine collection)\r\nTotal bilirubin: ? 1.5 � ULN Subjects with a bile duct obstruction will be eligible if they meet the criteria after appropriate bile drainage; Patients with Gilbert syndrome should also be included after confirming that the total bilirubin level is ? 1.5 x ULN in a follow-up screening test.\r\nPhase Ib: Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ? 3 x ULN (regardless of liver metastases)\r\nPhase II: AST and ALT ? 3 x ULN if liver metastases are absent, or AST and ALT ? 5 x ULN if liver metastases are present.\r\nThe subject is able to swallow and retain oral medication\r\nSerum ?-HCG test negative within 14 days before the first administration of the study treatment (women of childbearing potential only).\r\nRequirement for contraception must be observed by the subject.'}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05214222,"{Official Title': 'Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study', 'Brief Summary': 'Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study', 'Condition': 'Essential Tremor', 'Detailed Description': 'This is a open-label, phase II study of Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy in subjects With resectable advanced esophageal squamous cell carcinoma. The patients will be divided into two groups. In group A, Penpulimab plus chemotherapy with Anlotinib will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Anlotinib and Penpulimab will be used every 3 weeks until disease progression or intolerance; In group B, Penpulimab plus chemotherapy will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Penpulimab will be used every 3 weeks until disease progression or intolerance;', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients with advanced metastatic esophageal squamous cell carcinoma who cannot receive radical treatment (excluding mixed adenosquamous carcinoma);\r\nThose who have not received systemic treatment in the past, or (new) adjuvant treatment/radical surgery/radical radiotherapy and chemotherapy have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after radiotherapy alone. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time> 2 weeks;\r\nAccording to the RECIST 1.1 version of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion; the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected);\r\nPatients between 18 and 75 years old;\r\nECOGPS score: 0~1 points; the expected survival period is more than 3 months;\r\nTumor specimens can be provided to determine gene detection and PD-L1 expression, at least 15 white sheets (assessed by the company); provide two oral swabs; within 7 days before the medication, the first, third, and sixth at the end of the cycle, one tube of 6ml EDTA anticoagulant blood will be provided.\r\nIt has sufficient organ and bone marrow function, that is, it meets the following standards:\r\n(1) The standard of routine blood examination must meet: Hemoglobin content (HB) ?90g/L (no blood transfusion within 28 days); Absolute neutrophil count (ANC) ?1.5�109/L; Platelet count (PLT) ?100�109/L. (2) The biochemical inspection shall meet the following standards: Serum total bilirubin (TBIL) ? 1.5 times the upper limit of normal (ULN); ALT and AST?2.5�ULN; if there is liver metastasis, ALT and AST?5�ULN; Cr?1.5�ULN or creatinine clearance (CCr)?60ml/min; (Cockcroft-Gault formula) (3) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) ? 1.5 times ULN; 8) Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the treatment, and they must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:\r\n\r\nPost-menopausal is defined as amenorrhea at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped;\r\nFor women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also Can be considered post-menopausal;\r\nHave received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation.\r\nFor men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05214222,"{Official Title': 'Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study', 'Brief Summary': 'Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study', 'Condition': 'Essential Tremor', 'Detailed Description': 'This is a open-label, phase II study of Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy in subjects With resectable advanced esophageal squamous cell carcinoma. The patients will be divided into two groups. In group A, Penpulimab plus chemotherapy with Anlotinib will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Anlotinib and Penpulimab will be used every 3 weeks until disease progression or intolerance; In group B, Penpulimab plus chemotherapy will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Penpulimab will be used every 3 weeks until disease progression or intolerance;', 'Inclusion Criteria': 'Inclusion Criteria:\n\nPatients with advanced metastatic esophageal squamous cell carcinoma who cannot receive radical treatment (excluding mixed adenosquamous carcinoma);\nThose who have not received systemic treatment in the past, or (new) adjuvant treatment/radical surgery/radical radiotherapy and chemotherapy have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after radiotherapy alone. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time> 2 weeks;\nAccording to the RECIST 1.1 version of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion; the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected);\nPatients between 18 and 75 years old;\nECOGPS score: 0~1 points; the expected survival period is more than 3 months;\nTumor specimens can be provided to determine gene detection and PD-L1 expression, at least 15 white sheets (assessed by the company); provide two oral swabs; within 7 days before the medication, the first, third, and sixth at the end of the cycle, one tube of 6ml EDTA anticoagulant blood will be provided.\nIt has sufficient organ and bone marrow function, that is, it meets the following standards:\n(1) The standard of routine blood examination must meet: Hemoglobin content (HB) ?90g/L (no blood transfusion within 28 days); Absolute neutrophil count (ANC) ?1.5�109/L; Platelet count (PLT) ?100�109/L. (2) The biochemical inspection shall meet the following standards: Serum total bilirubin (TBIL) ? 1.5 times the upper limit of normal (ULN); ALT and AST?2.5�ULN; if there is liver metastasis, ALT and AST?5�ULN; Cr?1.5�ULN or creatinine clearance (CCr)?60ml/min; (Cockcroft-Gault formula) (3) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) ? 1.5 times ULN; 8) Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the treatment, and they must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:\n\nPost-menopausal is defined as amenorrhea at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped;\nFor women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also Can be considered post-menopausal;\nHave received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation.\nFor men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05842317,"{Official Title': 'A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.', 'Brief Summary': 'To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nParticipants must meet all of the following criteria to be included:\r\nParticipants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.\r\nParticipants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.\r\nParticipants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.\r\nPatients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.\r\nParticipants must not have received systemic treatment.\r\nThere must be at least one measurable lesion (according to RECIST 1.1 criteria, the measurable lesion must have a spiral CT scan long diameter ?10 mm or an enlarged lymph node short diameter ?15 mm).\r\nECOG performance status must be 0-1 point within 1 week before enrollment.\r\nChild-Pugh liver function grade: Class A (5-6 points).\r\nExpected survival time ?3 months.\r\nActive hepatitis B or C patients must receive relevant antiviral treatment, with HBV-DNA <2500 IU/mL (<105 copies/mL) and have received antiviral treatment for at least 14 days before participating in the study. HCV RNA-positive patients must be treated according to local standard treatment guidelines and have liver function increased no more than Grade 1 in CTCAE during treatment.\r\nHematological and organ function must be adequate, based on laboratory test results obtained within 14 days before starting the study treatment, unless otherwise specified:\r\nComplete blood count: (not transfused, not treated with G-CSF or drugs for correction) white blood cell count ? 3.0 x 109/L, Hb ? 90 g/L, neutrophil count ? 1.5 � 109/L, and platelet count ? 60 � 109/L.\r\n\r\nBiochemical tests: (not given albumin in the last 14 days)\r\nAppropriate liver function: ALB ? 29 g/L, ALP, ALT, and AST <5 � ULN, TBIL ? 3 � ULN, and PT prolongation time no more than 6s of ULN\r\nAppropriate renal function: Creatinine ? 1.5 � ULN, or creatinine clearance (CCr) >50 mL/min (using the Cockcroft-Gault formula):\r\nFemale: CrCl = ((140 - age) � body weight (kg) � 0.85) / 72 � serum creatinine (mg/dL) Male: CrCl = ((140 - age) � body weight (kg) � 1.00) / 72 � serum creatinine (mg/dL)\r\n\r\n� Women of childbearing potential: must agree to abstain from sexual activity or use a contraceptive method with a failure rate of less than 1% for at least 6 months during the treatment period and after the last dose.\r\n\r\nIf a female patient has menstruated and has not yet reached postmenopausal status (no menstrual periods for ?12 months continuously, and no other causes for menopause except surgical sterilization), and has not undergone sterilization surgery (removal of the ovaries and/or uterus), she is considered to be of childbearing potential.'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05842317,"{Official Title': 'A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.', 'Brief Summary': 'To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be included:\nParticipants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.\nParticipants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.\nParticipants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.\nPatients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.\nParticipants must not have received systemic treatment.\nThere must be at least one measurable lesion (according to RECIST 1.1 criteria, the measurable lesion must have a spiral CT scan long diameter ?10 mm or an enlarged lymph node short diameter ?15 mm).\nECOG performance status must be 0-1 point within 1 week before enrollment.\nChild-Pugh liver function grade: Class A (5-6 points).\nExpected survival time ?3 months.\nActive hepatitis B or C patients must receive relevant antiviral treatment, with HBV-DNA <2500 IU/mL (<105 copies/mL) and have received antiviral treatment for at least 14 days before participating in the study. HCV RNA-positive patients must be treated according to local standard treatment guidelines and have liver function increased no more than Grade 1 in CTCAE during treatment.\nHematological and organ function must be adequate, based on laboratory test results obtained within 14 days before starting the study treatment, unless otherwise specified:\nComplete blood count: (not transfused, not treated with G-CSF or drugs for correction) white blood cell count ? 3.0 x 109/L, Hb ? 90 g/L, neutrophil count ? 1.5 � 109/L, and platelet count ? 60 � 109/L.\n\nBiochemical tests: (not given albumin in the last 14 days)\nAppropriate liver function: ALB ? 29 g/L, ALP, ALT, and AST <5 � ULN, TBIL ? 3 � ULN, and PT prolongation time no more than 6s of ULN\nAppropriate renal function: Creatinine ? 1.5 � ULN, or creatinine clearance (CCr) >50 mL/min (using the Cockcroft-Gault formula):\nFemale: CrCl = ((140 - age) � body weight (kg) � 0.85) / 72 � serum creatinine (mg/dL) Male: CrCl = ((140 - age) � body weight (kg) � 1.00) / 72 � serum creatinine (mg/dL)\n\n� Women of childbearing potential: must agree to abstain from sexual activity or use a contraceptive method with a failure rate of less than 1% for at least 6 months during the treatment period and after the last dose.\n\nIf a female patient has menstruated and has not yet reached postmenopausal status (no menstrual periods for ?12 months continuously, and no other causes for menopause except surgical sterilization), and has not undergone sterilization surgery (removal of the ovaries and/or uterus), she is considered to be of childbearing potential.'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05163249,"{Official Title': 'A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS)\n', 'Brief Summary': 'This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC.\n', 'Condition': 'Carcinoma, Non-Small-Cell Lung', 'Detailed Description': 'Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study.\n\nAll eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.\n\nPatients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nInformed consent\n\nCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\nProvision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n\nAge\n\nParticipant must be ?18 years at the time of signing the ICF. All genders are permitted.\n\nType of Participant and Disease Characteristics\n\nHistologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity.\nHas not received any systemic treatment of advanced NSCLC.\n\nPrior adjuvant/neo-adjuvant therapy completed > 6 months before screening is allowed.\nMET amplification/high expression as determined by FISH, IHC or NGS testing on tumor tissue collected before any systemic treatment in first line.\n\nMET high expression by IHC, 3+ in ?75% of tumor cells\nincreased MET gene copy number by FISH, MET gene copy ?5 or MET / CEP7 ratio ?2; or by tissue NGS, ?20% tumour cells, ?200x sequencing depth of coverage and CN ?5.\nLocal IHC, FISH and pre-existing local NGS results are acceptable, central FISH and central NGS confirmation is highly suggested if tissue sample available.\nWHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing and a minimum life expectancy of 12 weeks.\nAt least 1 lesion that can be accurately measured at baseline as ?10 mm in the longest diameter (except lymph nodes, which must have short axis ?15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\nAdequate haematological function defined as:\n\nHaemoglobin?8.5 g/dL (no transfusion in the past 2 weeks).\nAbsolute neutrophil count ?1.5�109/L.\nPlatelet count ?100,000/?L (no transfusion in the past 10 days)\nAdequate liver function defined as:\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ?2.5 x the upper limit of normal (ULN) with total bilirubin (TBL) ? ULN\nOR TBL >ULN to ?1.5x ULN with ALT and AST ? ULN\nAdequate renal function defined as a creatinine <1.5 times the institutional ULN OR a glomerular filtration rate ?50 mL/min, as assessed using the standard methodology at the investigating centre (eg, Cockcroft-Gault, Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration formulae, ethylenediaminetetraacetic acid clearance or 24-hour urine collection). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.\nAdequate coagulation parameters, defined as:\n\nInternational Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters.\nPatients with known tumor thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin (LMWH) for ?2 weeks.\nAbility to swallow and retain oral medications.\nWillingness and ability to comply with study and follow-up procedures.\n\nReproduction\n\nFemales must be using highly effective contraceptive measures (see Section 5.3.2), and have a negative pregnancy test (serum) for women of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:\n\nPost-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\nWomen under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\nWomen with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\nFurther information is available in Appendix F (Contraception Requirements).\nMale patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05163249,"{Official Title': 'A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS)\n', 'Brief Summary': 'This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC.\n', 'Condition': 'Carcinoma, Non-Small-Cell Lung', 'Detailed Description': 'Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study.\n\nAll eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.\n\nPatients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nInformed consent\n\nCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\nProvision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n\nAge\n\nParticipant must be ?18 years at the time of signing the ICF. All genders are permitted.\n\nType of Participant and Disease Characteristics\n\nHistologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity.\nHas not received any systemic treatment of advanced NSCLC.\n\nPrior adjuvant/neo-adjuvant therapy completed > 6 months before screening is allowed.\nMET amplification/high expression as determined by FISH, IHC or NGS testing on tumor tissue collected before any systemic treatment in first line.\n\nMET high expression by IHC, 3+ in ?75% of tumor cells\nincreased MET gene copy number by FISH, MET gene copy ?5 or MET / CEP7 ratio ?2; or by tissue NGS, ?20% tumour cells, ?200x sequencing depth of coverage and CN ?5.\nLocal IHC, FISH and pre-existing local NGS results are acceptable, central FISH and central NGS confirmation is highly suggested if tissue sample available.\nWHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing and a minimum life expectancy of 12 weeks.\nAt least 1 lesion that can be accurately measured at baseline as ?10 mm in the longest diameter (except lymph nodes, which must have short axis ?15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\nAdequate haematological function defined as:\n\nHaemoglobin?8.5 g/dL (no transfusion in the past 2 weeks).\nAbsolute neutrophil count ?1.5�109/L.\nPlatelet count ?100,000/?L (no transfusion in the past 10 days)\nAdequate liver function defined as:\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ?2.5 x the upper limit of normal (ULN) with total bilirubin (TBL) ? ULN\nOR TBL >ULN to ?1.5x ULN with ALT and AST ? ULN\nAdequate renal function defined as a creatinine <1.5 times the institutional ULN OR a glomerular filtration rate ?50 mL/min, as assessed using the standard methodology at the investigating centre (eg, Cockcroft-Gault, Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration formulae, ethylenediaminetetraacetic acid clearance or 24-hour urine collection). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.\nAdequate coagulation parameters, defined as:\n\nInternational Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters.\nPatients with known tumor thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin (LMWH) for ?2 weeks.\nAbility to swallow and retain oral medications.\nWillingness and ability to comply with study and follow-up procedures.\n\nReproduction\n\nFemales must be using highly effective contraceptive measures (see Section 5.3.2), and have a negative pregnancy test (serum) for women of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:\n\nPost-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\nWomen under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\nWomen with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\nFurther information is available in Appendix F (Contraception Requirements).\nMale patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03675737,"{Official Title': 'A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).', 'Condition': 'Stomach Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status\nHas human epidermal growth factor receptor 2 (HER2) negative cancer\nMale Participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period\nFemale Participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period\nHas measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\nHas provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis\nHas provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention\nHas adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03675737,"{Official Title': 'A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.\r\n\r\nThe primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).', 'Condition': 'Stomach Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status\nHas human epidermal growth factor receptor 2 (HER2) negative cancer\nMale Participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period\nFemale Participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period\nHas measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\nHas provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis\nHas provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention\nHas adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03064867,"{Official Title': 'Phase I/II Trial of Venetoclax in Combination With R-ICE (V+RICE) Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma', 'Brief Summary': 'The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, venetoclax, to a standard combination of chemotherapy drugs as a second treatment for relapsed/refractory DLBCL. In this study, venetoclax will be added to RICE (rituximab, ifosfamide, carboplatin, etoposide), a common set to cancer drugs used as a second line treatment for relapsed/refractory DLBCL.\r\n\r\nVenetoclax, is a new targeted anti-cancer drug, which works by mimicking a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the standard RICE regimen is believed to increase the chance of getting cancer into remission.\r\n\r\nVenetoclax is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of relapsed/refractory DLBCL. Venetoclax has been FDA approved for use in patients with chronic lymphocytic leukemia (CLL).', 'Condition': 'Diffuse Large B-cell-lymphoma', 'Detailed Description': 'Primary Objective:\r\n\r\nEstablishment of safety of V+RICE in order to identify the recommended Phase II dose (RPD2)\r\n\r\nSecondary Objectives:\r\n\r\nDetermine the overall response rate (ORR) of V+RICE relative to historical controls of RICE alone in r/r DLBCL.\r\nDetermine the proportion of patients who proceed to autologous stem cell transplantation after V+RICE relative to historical controls.\r\nDescribe the progression-free survival (PFS) and overall survival (OS) for patients treated with V + RICE who do and do not proceed to auto-Stem Cell Transplant, relative to historical controls.\r\nMeasure total number of peripheral blood stem cells collected in patients treated with V + RICE who proceed to stem cell mobilization/harvesting, compared to historical controls.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nHistological confirmation of relapsed/refractory diffuse large B-cell lymphoma after prior rituximab and anthracycline-containing systemic treatment regimen such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), R-EPOCH (rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride), R-HyperCVAD (rituximab, cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone) etc. A biopsy immediately before enrollment is not required.\r\nSubjects must have received no more than 2 prior systemic therapies for lymphoma. Prior therapy with systemic rituximab monotherapy or conventional chemotherapy (i.e. bendamustine, CVP (Cyclophosphamide, Vincristine Sulfate, Prednisone) or other) � rituximab for indolent non-Hodgkin's lymphoma (NHL) � maintenance/extended-use rituximab will count as 1 line of systemic therapy.\r\nEastern Cooperative Oncology Group (ECOG) Performance status ? 2\r\nSubjects must have normal organ and marrow function as defined below:\r\n\r\nHemoglobin ? 8.0 g/dl\r\nAbsolute neutrophil count ? 1,000/mcL\r\nPlatelet count ? 75,000/mcL\r\nTotal bilirubin ? 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert's, for whom the maximum will be 2.5 ULN.\r\nAspartate transaminase (AST) (SGOT) ? 2.5 X institutional ULN\r\nAlanine transaminase (ALT) (SGPT) ? 2.5 X institutional ULN\r\nInternational normalized ratio (INR) ? 1.5 �ULN\r\nPatients must have a calculated serum creatinine clearance > 50 mL/min using Cockcroft-Gault calculation or based on 24-hour urine collection performed within 7 days prior to treatment.\r\nSpecific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on Hepatitis B serological testing as follow:\r\n\r\nHBsAg negative, HBcAb negative, HBsAb negative patients are eligible.\r\nHBsAg negative, HBcAb negative, HBsAb positive patients are eligible.\r\nPatients who test positive for HBsAg are ineligible\r\nPatients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a HBV DNA testing performed and protocol eligibility determined as follow:\r\n\r\nIf HBV DNA is positive, the subject is ineligible.\r\nIf HBV DNA is negative, the subject may be included but must undergo HBV DNA PCR testing monthly x 3 months beginning from the start of treatment\r\nSubjects must have the ability to understand and the willingness to sign a written informed consent document.\r\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax or 18 months after the last dose of rituximab, whichever is longer.\r\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).\r\n\r\nFor men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\r\nWith female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of rituximab. Men must refrain from donating sperm during this same period.\r\n\r\nWith pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of rituximab to avoid exposing the embryo.""}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT01843374,"{Official Title': 'A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Brief Summary': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period', 'Condition': 'Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Detailed Description': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.\r\n\r\nRandomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.\r\n\r\nThe study consists of a screening period, a treatment period, and a 90-day follow-up period', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma;\r\nDisease not amenable to curative surgery;\r\nAge 18 and over at the time of consent;\r\nECOG Performance status 0-1;\r\nProgressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.\r\nRecovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or\r\n1, except for toxicities not considered a safety risk, 7. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as: 9. Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. 10. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations; 11. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. 2. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product.'}",{'Arm - Disease - Line of Therapy': 'Second- or Third-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT01843374,"{Official Title': 'A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Brief Summary': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period', 'Condition': 'Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Detailed Description': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.\r\n\r\nRandomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.\r\n\r\nThe study consists of a screening period, a treatment period, and a 90-day follow-up period', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma;\r\nDisease not amenable to curative surgery;\r\nAge 18 and over at the time of consent;\r\nECOG Performance status 0-1;\r\nProgressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.\r\nRecovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or\r\n1, except for toxicities not considered a safety risk, 7. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as: 9. Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. 10. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations; 11. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. 2. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product.'}",{'Arm - Disease - Line of Therapy': 'Second- or Third-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03504397,"{Official Title': 'A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Brief Summary': 'A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n\nWhy is this study being done?\n\nSPOTLIGHT is a new clinical study for adult patients who have any of:\n\nadvanced unresectable gastric or GEJ cancer\nmetastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.\nFor patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.\n\nPatients will be assigned to one of two groups by chance and given either:\n\nzolbetuximab with mFOLFOX6; or\na placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.\nThe goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.', 'Condition': 'Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Detailed Description': 'The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nFemale subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:\n\nNot a woman of child-bearing potential (WOCBP) OR\nWOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs\nFemale subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nFemale subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.\nA sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.\nMale subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nMale subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.\nSubject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.\nSubject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.\nSubject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ? 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ? 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\nSubject's tumor expresses CLDN18.2 in ? 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.\nSubject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.\nSubject has ECOG performance status 0 to 1.\nSubject has predicted life expectancy ? 12 weeks.\nSubject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.\n\nHemoglobin (Hgb) ? 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ? 9 g/dL.\nAbsolute neutrophil count (ANC) ? 1.5 x 10^9/L\nPlatelets ? 100 x 10^9/L\nAlbumin ? 2.5 g/dL\nTotal bilirubin ? 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN without liver metastases (or ? 5 x ULN if liver metastases are present)\nEstimated creatinine clearance ? 30 mL/min\nProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ? 1.5 x ULN (except for subjects receiving anticoagulation therapy)""}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03504397,"{Official Title': 'A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Brief Summary': 'A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n\nWhy is this study being done?\n\nSPOTLIGHT is a new clinical study for adult patients who have any of:\n\nadvanced unresectable gastric or GEJ cancer\nmetastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.\nFor patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.\n\nPatients will be assigned to one of two groups by chance and given either:\n\nzolbetuximab with mFOLFOX6; or\na placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.\nThe goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.', 'Condition': 'Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Detailed Description': 'The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nFemale subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:\n\nNot a woman of child-bearing potential (WOCBP) OR\nWOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs\nFemale subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nFemale subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.\nA sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.\nMale subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nMale subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.\nSubject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.\nSubject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.\nSubject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ? 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ? 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\nSubject's tumor expresses CLDN18.2 in ? 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.\nSubject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.\nSubject has ECOG performance status 0 to 1.\nSubject has predicted life expectancy ? 12 weeks.\nSubject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.\n\nHemoglobin (Hgb) ? 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ? 9 g/dL.\nAbsolute neutrophil count (ANC) ? 1.5 x 10^9/L\nPlatelets ? 100 x 10^9/L\nAlbumin ? 2.5 g/dL\nTotal bilirubin ? 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN without liver metastases (or ? 5 x ULN if liver metastases are present)\nEstimated creatinine clearance ? 30 mL/min\nProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ? 1.5 x ULN (except for subjects receiving anticoagulation therapy)""}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05904886,"{Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma\n', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).\n', 'Condition': 'Carcinoma, Hepatocellular\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nLocally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants\nDisease that is not amenable to curative surgical and/or locoregional therapies\nNo prior systemic treatment for locally advanced or metastatic and/or unresectable HCC\nMeasurable disease according to RECIST v1.1\nECOG Performance Status of 0 or 1 within 7 days prior to randomization\nChild-Pugh Class A within 7 days prior to randomization\nAdequate hematologic and end-organ function\nFemale participants of childbearing potential must be willing to avoid pregnancy\nMale participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05904886,"{Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma\n', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).\n', 'Condition': 'Carcinoma, Hepatocellular\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nLocally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants\nDisease that is not amenable to curative surgical and/or locoregional therapies\nNo prior systemic treatment for locally advanced or metastatic and/or unresectable HCC\nMeasurable disease according to RECIST v1.1\nECOG Performance Status of 0 or 1 within 7 days prior to randomization\nChild-Pugh Class A within 7 days prior to randomization\nAdequate hematologic and end-organ function\nFemale participants of childbearing potential must be willing to avoid pregnancy\nMale participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04199104,"{Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\n\nHypotheses include:\n\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\n\nHas a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\n\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\n\nMale participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\nFemale participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\nHas measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.\nParticipants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\nHas an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\nHas adequately controlled blood pressure with or without antihypertensive medications.\nHas adequate organ function.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04199104,"{Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\n\nHypotheses include:\n\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\n\nHas a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\n\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\n\nMale participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\nFemale participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\nHas measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.\nParticipants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\nHas an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\nHas adequately controlled blood pressure with or without antihypertensive medications.\nHas adequate organ function.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05523323,"{Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\r\n\r\nHypotheses include:\r\n\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': 'The MK-7902-010-China Extension Study will include participants previously enrolled in China in the global study for MK-7902-010 (NCT04199104) plus those enrolled during the China extension enrollment period.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n- Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\r\n\r\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\r\n\r\n- Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\r\n\r\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\r\n\r\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\r\n\r\nMale participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\r\nFemale participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\r\nHas measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.\r\nParticipants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\r\nHas adequately controlled blood pressure with or without antihypertensive medications.\r\nHas adequate organ function.'}",{'Arm - Disease - Line of Therapy': 'First-Line '},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05523323,"{Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\r\n\r\nHypotheses include:\r\n\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': 'The MK-7902-010-China Extension Study will include participants previously enrolled in China in the global study for MK-7902-010 (NCT04199104) plus those enrolled during the China extension enrollment period.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n- Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\r\n\r\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\r\n\r\n- Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\r\n\r\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\r\n\r\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\r\n\r\nMale participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\r\nFemale participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\r\nHas measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.\r\nParticipants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\r\nHas adequately controlled blood pressure with or without antihypertensive medications.\r\nHas adequate organ function.'}",{'Arm - Disease - Line of Therapy': 'First-Line '},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04571489,"{Official Title': 'Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study', 'Brief Summary': 'This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.', 'Condition': 'Pancreatic Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed pancreatic cancer originating from pancreatic ductal epithelium, excluding pancreatic endocrine tumor;\r\nLocally advanced or metastatic pancreatic cancer in no condition for radical radiotherapy or operation;\r\nFailed in first-line gemcitabine or fluorouracil drugs chemotherapy (Recurrence within 6 months after treatment, progression or toxicity intolerance during treatment);\r\nChemotherapy, targeted therapy or radical radiotherapy should be stopped 3 weeks ago, immunotherapy should be stopped 4 weeks ago, and previous toxicity recovered (CTCAE ? level 1);\r\nMeasurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\r\nNo younger than 18 years old of either gender;\r\nEastern Cooperative Oncology Group (ECOG) performance status score 0-1;\r\nEstimated life expectancy >3 months;\r\nThe function of important organs meets the following requirements:\r\n\r\nabsolute neutrophil count (ANC) ? 1.5�109/L, platelets ? 85�109/L, hemoglobin ? 90g/L;\r\nserum creatinine ? 1.5�ULN, creatinine clearance rate ?60 mL/min, U-pro < 2+ or 1.0g/L; if U-pro ?2+ or 1.0g/L, 24 hours U-pro ? 1.0g/L can be included;\r\ntotal bilirubin ? 1.5�ULN, obstructive jaundice with biliary drainage: total bilirubin ? 2.0�ULN; alanine transaminase and aspartate aminotransferase ? 2.5�ULN, liver metastasis ? 5.0�ULN; serum albumin ? 30g/L;\r\nWithout a history of allergy or hypersensitivity to camptothecin drugs;\r\nTaking drugs orally;\r\nSerum human chorionic gonadotropin negative in premenopausal women; female patients of childbearing potential and male patients with female partners of childbearing potential must be willing to avoid pregnancy;\r\nAbility to understand the study and sign informed consent.\r\n'}",{'Arm - Disease - Line of Therapy': 'Second- Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04571489,"{Official Title': 'Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study', 'Brief Summary': 'This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.', 'Condition': 'Pancreatic Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed pancreatic cancer originating from pancreatic ductal epithelium, excluding pancreatic endocrine tumor;\r\nLocally advanced or metastatic pancreatic cancer in no condition for radical radiotherapy or operation;\r\nFailed in first-line gemcitabine or fluorouracil drugs chemotherapy (Recurrence within 6 months after treatment, progression or toxicity intolerance during treatment);\r\nChemotherapy, targeted therapy or radical radiotherapy should be stopped 3 weeks ago, immunotherapy should be stopped 4 weeks ago, and previous toxicity recovered (CTCAE ? level 1);\r\nMeasurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\r\nNo younger than 18 years old of either gender;\r\nEastern Cooperative Oncology Group (ECOG) performance status score 0-1;\r\nEstimated life expectancy >3 months;\r\nThe function of important organs meets the following requirements:\r\n\r\nabsolute neutrophil count (ANC) ? 1.5�109/L, platelets ? 85�109/L, hemoglobin ? 90g/L;\r\nserum creatinine ? 1.5�ULN, creatinine clearance rate ?60 mL/min, U-pro < 2+ or 1.0g/L; if U-pro ?2+ or 1.0g/L, 24 hours U-pro ? 1.0g/L can be included;\r\ntotal bilirubin ? 1.5�ULN, obstructive jaundice with biliary drainage: total bilirubin ? 2.0�ULN; alanine transaminase and aspartate aminotransferase ? 2.5�ULN, liver metastasis ? 5.0�ULN; serum albumin ? 30g/L;\r\nWithout a history of allergy or hypersensitivity to camptothecin drugs;\r\nTaking drugs orally;\r\nSerum human chorionic gonadotropin negative in premenopausal women; female patients of childbearing potential and male patients with female partners of childbearing potential must be willing to avoid pregnancy;\r\nAbility to understand the study and sign informed consent.\r\n'}",{'Arm - Disease - Line of Therapy': 'Second- Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT01946477,"{Official Title': 'A Phase 2, Multicenter, Multi-cohort, Open-label Study of Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting.', 'Brief Summary': 'This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy.\r\n\r\nThis trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.\r\n\r\nThis trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.\r\n\r\nThis trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of >60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.', 'Condition': 'Multiple Myeloma', 'Detailed Description': 'A phase 2, multicenter, multi-cohort, open-label study of pomalidomide in combination with low-dose dexamethasone or pomalidomide in combination with low-dose dexamethasone and daratumumab in subjects with relapsed or refractory multiple myeloma following lenalidomide based therapy in the first or second line setting.\r\n\r\nThis trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSubjects must satisfy the following criteria to be enrolled in the study:\r\n\r\nAdults (age ? 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein ? 0.5 g/dL or urine M-protein ? 200 mg/24 hours).\r\nSubjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy.\r\nAll subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen.\r\nAll subjects must have documented disease progression during or after their last antimyeloma therapy.\r\nSubjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\r\nSubjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted.\r\nSubjects must be able to adhere to the study visit schedule and other protocol requirements.\r\nAll subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes.\r\nFemales with child-bearing potential (FCBP�) must agree to use 2 reliable forms of contraception* simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. For subjects enrolled in Cohort B and Cohort C, pregnancy prevention and testing will continue until 3 months after last dose of daratumumab.\r\nFemales must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation. Female subjects enrolled in Cohort B and Cohort C must agree to abstain from breastfeeding and donating eggs during study participation and until 3 months after last dose of daratumumab.\r\nMales must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B and Cohort C must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab.\r\nMales must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B and Cohort C must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab.\r\nAll subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment.\r\nAll subjects must agree not to share medication.'}",{'Arm - Disease - Line of Therapy': 'First or Second Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT01946477,"{Official Title': 'A Phase 2, Multicenter, Multi-cohort, Open-label Study of Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting.', 'Brief Summary': 'This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy.\r\n\r\nThis trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.\r\n\r\nThis trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.\r\n\r\nThis trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of >60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.', 'Condition': 'Multiple Myeloma', 'Detailed Description': 'A phase 2, multicenter, multi-cohort, open-label study of pomalidomide in combination with low-dose dexamethasone or pomalidomide in combination with low-dose dexamethasone and daratumumab in subjects with relapsed or refractory multiple myeloma following lenalidomide based therapy in the first or second line setting.\n\nThis trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSubjects must satisfy the following criteria to be enrolled in the study:\r\n\r\nAdults (age ? 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein ? 0.5 g/dL or urine M-protein ? 200 mg/24 hours).\r\nSubjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy.\r\nAll subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen.\r\nAll subjects must have documented disease progression during or after their last antimyeloma therapy.\r\nSubjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\r\nSubjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted.\r\nSubjects must be able to adhere to the study visit schedule and other protocol requirements.\r\nAll subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes.\r\nFemales with child-bearing potential (FCBP�) must agree to use 2 reliable forms of contraception* simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. For subjects enrolled in Cohort B and Cohort C, pregnancy prevention and testing will continue until 3 months after last dose of daratumumab.\r\nFemales must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation. Female subjects enrolled in Cohort B and Cohort C must agree to abstain from breastfeeding and donating eggs during study participation and until 3 months after last dose of daratumumab.\r\nMales must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B and Cohort C must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab.\r\nMales must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B and Cohort C must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab.\r\nAll subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment.\r\nAll subjects must agree not to share medication.'}",{'Arm - Disease - Line of Therapy': 'First or Second Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04204941,"{Official Title': 'A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma\n', 'Brief Summary': 'The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue.\n\nPart 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study.\n\nPart 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse.\n\nThe study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma', 'Condition': 'Advanced Soft-tissue Sarcoma\nAdvanced Epithelioid Sarcoma', 'Detailed Description': 'The open-label phase 1b portion is designed to evaluate the safety of the combination of tazemetostat + doxorubicin, as well as to establish the maximum tolerated dose (MTD) and the RP3D. The phase 3 portion of the clinical trial aims to compare tazemetostat + doxorubicin to the current front-line standard treatment, single-agent doxorubicin + placebo, when used as first-line treatment in locally advanced unresectable or metastatic ES.', 'Inclusion Criteria': 'Inclusion Criteria\n\nParticipants must meet ALL the following inclusion criteria to be eligible to enroll in this study:\n\nHave voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. Study related activities will not start until written consent is obtained.\nLife expectancy ? 3 months before enrollment\nPhase 1b: 18-65 years old histologically confirmed Soft Tissue Sarcoma\nPhase 3: ?18 years old with unresectable locally advanced or metastatic Epithelioid Sarcoma and tumor tissue available\nHave measurable disease\nECOG performance status of 0, 1, or 2\nHave adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function as required per protocol\nFemales must not be lactating or pregnant at Screening or Baseline\nFemales must not be pregnant or breast feeding and agree to use highly effective contraception during the clinical trial and for 6 months following the final dose of study\nMale participants of child-bearing potential must have had either a successful vasectomy or practice highly effective contraception\nParticipants diagnosed with human immunodeficiency virus (HIV) are eligible to participate in the study if their infection is well controlled on anti-retroviral therapy'}",{'Arm - Disease - Line of Therapy': 'Frontline'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04204941,"{Official Title': 'A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma\n', 'Brief Summary': 'The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue.\n\nPart 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study.\n\nPart 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse.\n\nThe study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma', 'Condition': 'Advanced Soft-tissue Sarcoma\nAdvanced Epithelioid Sarcoma', 'Detailed Description': 'The open-label phase 1b portion is designed to evaluate the safety of the combination of tazemetostat + doxorubicin, as well as to establish the maximum tolerated dose (MTD) and the RP3D. The phase 3 portion of the clinical trial aims to compare tazemetostat + doxorubicin to the current front-line standard treatment, single-agent doxorubicin + placebo, when used as first-line treatment in locally advanced unresectable or metastatic ES.', 'Inclusion Criteria': 'Inclusion Criteria\n\nParticipants must meet ALL the following inclusion criteria to be eligible to enroll in this study:\n\nHave voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. Study related activities will not start until written consent is obtained.\nLife expectancy ? 3 months before enrollment\nPhase 1b: 18-65 years old histologically confirmed Soft Tissue Sarcoma\nPhase 3: ?18 years old with unresectable locally advanced or metastatic Epithelioid Sarcoma and tumor tissue available\nHave measurable disease\nECOG performance status of 0, 1, or 2\nHave adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function as required per protocol\nFemales must not be lactating or pregnant at Screening or Baseline\nFemales must not be pregnant or breast feeding and agree to use highly effective contraception during the clinical trial and for 6 months following the final dose of study\nMale participants of child-bearing potential must have had either a successful vasectomy or practice highly effective contraception\nParticipants diagnosed with human immunodeficiency virus (HIV) are eligible to participate in the study if their infection is well controlled on anti-retroviral therapy'}",{'Arm - Disease - Line of Therapy': 'Frontline'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT02601950,"{Official Title': 'A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma', 'Brief Summary': 'This study will include participants with various types of cancer known as soft-tissue sarcomas.\n\nTissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments.\n\nSoft tissue cancers are rare and can occur almost anywhere in the body.\n\nPart 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability).\n\nIt is also designed to establish a recommended study drug dosage for the next part of the study.\n\nPart 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).', 'Condition': 'Malignant Rhabdoid Tumors (MRT), Rhabdoid Tumors of the Kidney (RTK), Atypical Teratoid Rhabdoid Tumors (ATRT), Selected Tumors With Rhabdoid Features, Synovial Sarcoma, INI1-negative Tumors, Malignant Rhabdoid Tumor of Ovary, Renal Medullary Carcinoma, Epithelioid Sarcoma, Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval), Any Solid Tumor With an EZH2 GOF Mutation', 'Detailed Description': ""This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID (twice daily) and 1600 mg QD (once daily). Subjects will be screened for eligibility within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of 8 cohorts:\n\nCohort using tazemetostat 800 mg BID\n\nCohort 1 (Closed for enrollment): malignant rhabdoid tumor (MRT), rhabdoid tumor of the kidney (RTK), atypical teratoid rhabdoid tumor (ATRT), and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type (SCCOHT), also known as malignant rhaboid tumor of the ovary (MRTO)\nCohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement\nCohort 3 (Closed for enrollment): Other integrase interactor 1 (INI1) negative tumors or any solid tumor with an enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma\nCohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC)\nCohort 5 (Closed for enrollment): Epithelioid sarcoma (ES)\nCohort 6 (Closed for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor biopsy\nCohort 7 (Closed for enrollment): Poorly differentiated chordoma (or other chordoma with Sponsor approval)\nCohort using tazemetostat 1600 mg QD\n\n� Cohort 8 (Closed for enrollment): Epitheliod sarcoma\n\nParticipants will be dosed in continuous 28-day cycles. (Note: if treatment with study drug is discontinued prior to completing 2 years, subjects will be followed for a maximum duration of 2 years from start of study drug dosing.) Response assessment will be performed every 8 weeks while on study.\n\nTreatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study."", 'Inclusion Criteria': ""Inclusion Criteria:\n\nAge (at the time of consent/assent): ?18 years of age\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\nHas provided signed written informed consent\nHas a life expectancy of >3 months\nHas a malignancy:\n\nFor which there are no standard therapies available (Cohorts 1, 3, 4 and 5)\nThat is relapsed or refractory after treatment with an approved therapy(ies), defined as metastatic or non-resectable, locally advanced disease that has previously been treated with and progressed following approved therapy(ies) (Cohort 2)\n\nThat has progressed within 6 months prior to study enrollment (Cohort 5 Expansion, Cohort 6 and Cohort 8 ONLY)\nHas a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA/College of American Pathologists (CAP) or equivalent laboratory certification\nFor Cohort 1 (rhabdoid tumors only), the following test results must be available by local laboratory: morphology and immunophenotypic panel consistent with rhabdoid tumors, and loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable\nFor Cohort 2 (subjects with relapsed/refractory synovial sarcoma only), the following tests must be available by local laboratory: Morphology consistent with synovial sarcomas, and cytogenetics or fluorescence in situ hybridization (FISH) and/or molecular confirmation (e.g., DNA sequencing) of SS18 rearrangement t(X;18)(p11;q11)\nFor Cohort 3, 4, 5, 7 and 8 (subjects with INI1-negative/aberrant tumors or any solid tumor with EZH2 GOF mutation only), the following test results must be available by local laboratory: Morphology and immunophenotypic panel consistent with INI1-negative tumors (not applicable for solid tumors with EZH2 GOF mutation), and loss of INI1 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 loss or mutation when INI1 IHC is equivocal or unavailable, or molecular evidence of EZH2 GOF mutation\nFor Cohort 6 (subjects with ES undergoing optional tumor biopsy) only:\n\nMorphology and immunophenotypic panel consistent with ES (e.g., CD34, EMA, Keratin, and INI1)\nHas all prior treatment (i.e. chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ?Grade 1 per CTCAE version 4.0.3 or are clinically stable and not clinically significant, at time of enrollment.\nPrior anti-cancer therapy(ies), if applicable, must be completed according to the criteria below:\n\nChemotherapy: cytotoxic (At least 14 days since last dose of chemotherapy prior to first dose of tazemetostat)\nChemotherapy: nitrosoureas (At least 6 weeks since last dose of nitrosoureas prior to first dose of tazemetostat)\nChemotherapy: non-cytotoxic (e.g., small molecule inhibitor) (At least 14 days since last dose of non-cytotoxic chemotherapy prior to first dose of tazemetostat)\nMonoclonal antibody(ies) (At least 28 days since the last dose of any monoclonal antibody prior to first dose of tazemetostat)\nImmunotherapy (e.g. tumor vaccine) (At least 42 days since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)\nRadiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereostatic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ?50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)\nHigh dose therapy with autologous hematopoietic cell infusion (At least 60 days from last infusion prior to first dose of tazemetostat)\nHematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat)\nHas sufficient tumor tissue (slides or blocks) available for central confirmatory testing\nHas measurable disease based on either RECIST 1.1 for solid tumors or RANO for CNS tumors\nHas adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function.\nFor subjects with CNS Tumors only, subject must have seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 21 days prior to the planned first dose of tazemetostat\nHas a shortening fraction of >27% or an ejection fraction of ?50% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan and New York Heart Association (NYHA) Class ?2\nHas a QT interval corrected by Fridericia's formula (QTcF) ?480 msec\nFemale subjects of childbearing potential must:\n\nHave a negative beta-human chorionic gonadotropin (?-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of tazemetostat and\nAgree to use effective contraception from a minimum of 7 days prior to first dose until 6 months following the last dose of tazemetostat and have a male partner who uses a condom, or\nPractice true abstinence or have a male partner who is vasectomized\nMale subjects with a female partner of childbearing potential must:\n\nBe vasectomized, or\nAgree to use condoms as defined in Section 8.6.2, from first dose of tazemetostat until 3 months following the last dose of tazemetostat, or\nHave a female partner who is NOT of childbearing potential""}",{'Arm - Disease - Line of Therapy': 'Frontline'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03092856,"{Official Title': 'Phase II Randomized Double Blind Trial of PF-04518600, an OX40 Antibody, in Combination With Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients With Metastatic Renal Cell Carcinoma', 'Brief Summary': 'This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody PF-04518600 work in treating patients with kidney cancer that has spread to other parts of the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made from living organisms that may may stimulate the immune system in different ways and stop tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody PF-04518600 may work better in treating patients with kidney cancer.', 'Condition': 'Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To determine whether a statistically significant improvement in progression free survival exists for patients receiving the combination.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether the combination is safe and whether objective response rate (ORR), duration of response (DOR) and overall survival (OS) improve as a result of treatment with combination of axitinib + anti-OX40 antibody PF-04518600 (PF-04518600 [OX40 Ab]) compared to axitinib + placebo.\n\nTERTIARY OBJECTIVES:\n\nI. To determine whether pre and post treatment specimens collected during the trial demonstrate significant changes in tumor microenvironment and enhanced immune response to tumor cells.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-14 and anti-OX40 antibody PF-04518600 intravenously (IV) over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30, 90, and 180 days.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nWilling and able to provide informed consent\nHistological confirmation of renal cell carcinoma (RCC) with a predominantly (> 50%) clear cell component\nMetastatic RCC\nMust have had a nephrectomy (radical or partial) and must provide the cell block from the nephrectomy\nMeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria\nMust have progression of disease within 6 months of study enrollment after treatment with only one of the following:\n\nTwo prior lines of therapy: a VEGF inhibitor (other than axitinib), followed by a single agent PD-1/PDL-1 antibody, or\nOne prior line of therapy: combination of a VEGF inhibitor (other than axitinib) AND a PD1/PDL1 antibody, or\nAdditional prior systemic treatments not allowed\nMust agree to a fresh core or excisional biopsy from a metastatic site within a 12-week window prior to enrollment; if such a biopsy is already available, cell blocks must be provided; (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission); specimens from the nephrectomy and fresh biopsy must be received and assessed for adequacy of tissue by the Data Coordinating Center (DCC) (University of Southern California [USC]) prior to randomization\nZubrod performance status of =< 2\nWomen of childbearing potential must use method(s) of contraception; the individual methods of contraception should be determined in consultation with the treating physician or investigator\nWomen of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the administration of the investigational product; female patients who are not of childbearing potential as defined below, are eligible to be included (ie, meet at least one of the following criteria):\n\nHave undergone a documented hysterectomy and/or bilateral oophorectomy\nHave medically confirmed ovarian failure; or\nAchieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women\nWomen must not be breastfeeding\nMen who are sexually active with women of childbearing potential must use any contraceptive method with a failure rate of less than 1% per year\nContraception should be continued using two highly effective methods for a period of 90 days\nSerum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) using actual weight (ideal or adjusted weights are unacceptable)\nWhite blood cells (WBC) >= 2000/uL\nNeutrophils >= 1500/uL\nPlatelets >= 100x10^3/uL\nHemoglobin >= 9g/dL\nAspartate aminotransferase (AST) =< 3 x ULN\nAlanine aminotransferase (ALT) =< 3 x ULN\nBilirubin =< 1.5 x ULN\n""}",{'Arm - Disease - Line of Therapy': 'Second-line or Third-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT03092856,"{Official Title': 'Phase II Randomized Double Blind Trial of PF-04518600, an OX40 Antibody, in Combination With Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients With Metastatic Renal Cell Carcinoma', 'Brief Summary': 'This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody PF-04518600 work in treating patients with kidney cancer that has spread to other parts of the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made from living organisms that may may stimulate the immune system in different ways and stop tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody PF-04518600 may work better in treating patients with kidney cancer.', 'Condition': 'Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To determine whether a statistically significant improvement in progression free survival exists for patients receiving the combination.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether the combination is safe and whether objective response rate (ORR), duration of response (DOR) and overall survival (OS) improve as a result of treatment with combination of axitinib + anti-OX40 antibody PF-04518600 (PF-04518600 [OX40 Ab]) compared to axitinib + placebo.\n\nTERTIARY OBJECTIVES:\n\nI. To determine whether pre and post treatment specimens collected during the trial demonstrate significant changes in tumor microenvironment and enhanced immune response to tumor cells.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-14 and anti-OX40 antibody PF-04518600 intravenously (IV) over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30, 90, and 180 days.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nWilling and able to provide informed consent\nHistological confirmation of renal cell carcinoma (RCC) with a predominantly (> 50%) clear cell component\nMetastatic RCC\nMust have had a nephrectomy (radical or partial) and must provide the cell block from the nephrectomy\nMeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria\nMust have progression of disease within 6 months of study enrollment after treatment with only one of the following:\n\nTwo prior lines of therapy: a VEGF inhibitor (other than axitinib), followed by a single agent PD-1/PDL-1 antibody, or\nOne prior line of therapy: combination of a VEGF inhibitor (other than axitinib) AND a PD1/PDL1 antibody, or\nAdditional prior systemic treatments not allowed\nMust agree to a fresh core or excisional biopsy from a metastatic site within a 12-week window prior to enrollment; if such a biopsy is already available, cell blocks must be provided; (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission); specimens from the nephrectomy and fresh biopsy must be received and assessed for adequacy of tissue by the Data Coordinating Center (DCC) (University of Southern California [USC]) prior to randomization\nZubrod performance status of =< 2\nWomen of childbearing potential must use method(s) of contraception; the individual methods of contraception should be determined in consultation with the treating physician or investigator\nWomen of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the administration of the investigational product; female patients who are not of childbearing potential as defined below, are eligible to be included (ie, meet at least one of the following criteria):\n\nHave undergone a documented hysterectomy and/or bilateral oophorectomy\nHave medically confirmed ovarian failure; or\nAchieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women\nWomen must not be breastfeeding\nMen who are sexually active with women of childbearing potential must use any contraceptive method with a failure rate of less than 1% per year\nContraception should be continued using two highly effective methods for a period of 90 days\nSerum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) using actual weight (ideal or adjusted weights are unacceptable)\nWhite blood cells (WBC) >= 2000/uL\nNeutrophils >= 1500/uL\nPlatelets >= 100x10^3/uL\nHemoglobin >= 9g/dL\nAspartate aminotransferase (AST) =< 3 x ULN\nAlanine aminotransferase (ALT) =< 3 x ULN\nBilirubin =< 1.5 x ULN\n""}",{'Arm - Disease - Line of Therapy': 'Second-line or Third-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT01927744,"{Official Title': 'Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection\n', 'Brief Summary': 'The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.\n\nIn this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.\n\nThis is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.\n\nUp to 100 patients will take part in this study. All will be enrolled at MD Anderson.', 'Condition': 'Head and Neck Cancer\n', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nSuspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.\nPatients must have surgically resectable disease, in the opinion of the treating physician\nAge ? 18 years.\nECOG PS ? 2 (Appendix C)\nAdequate bone marrow, hepatic and renal function defined by: 6. ANC ? 1.5 x 109/L;\n7. Platelet count ? 100 x 109/L;\n\n8. ALT (SGPT) ? 1.5 x upper limit of normal (ULN);\n\n9. Total bilirubin ? ULN (patient's with Gilbert's syndrome are eligible, even if total bilirubin is > ULN);\n\n10. Alkaline phosphatase ? 2.5 x ULN;\n\n11. Serum creatinine ? 1.5 x ULN.\n\n12. Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) ? 14 days prior to treatment initiation.\n\n13. Written informed consent to participate in the study according to the investigational review board (IRB).""}",{'Arm - Disease - Line of Therapy': 'Induction'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT01927744,"{Official Title': 'Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection\n', 'Brief Summary': 'The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.\n\nIn this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.\n\nThis is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.\n\nUp to 100 patients will take part in this study. All will be enrolled at MD Anderson.', 'Condition': 'Head and Neck Cancer\n', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nSuspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.\nPatients must have surgically resectable disease, in the opinion of the treating physician\nAge ? 18 years.\nECOG PS ? 2 (Appendix C)\nAdequate bone marrow, hepatic and renal function defined by: 6. ANC ? 1.5 x 109/L;\n7. Platelet count ? 100 x 109/L;\n\n8. ALT (SGPT) ? 1.5 x upper limit of normal (ULN);\n\n9. Total bilirubin ? ULN (patient's with Gilbert's syndrome are eligible, even if total bilirubin is > ULN);\n\n10. Alkaline phosphatase ? 2.5 x ULN;\n\n11. Serum creatinine ? 1.5 x ULN.\n\n12. Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) ? 14 days prior to treatment initiation.\n\n13. Written informed consent to participate in the study according to the investigational review board (IRB).""}",{'Arm - Disease - Line of Therapy': 'Induction'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04674956,"{Official Title': 'A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine Versus Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer', 'Brief Summary': 'Aim?Evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\r\n\r\nDrug information?\r\n\r\nanti-PD1 antibody (Camrelizumab)\r\nAG regimens?the standard first-line regimens for metastatic pancreatic cancer.', 'Condition': 'Pancreatic Cancer Stage IV, Pancreatic Cancer Metastatic', 'Detailed Description': ""CPOG1210-07 is a prospective, randomized, double-blinded, multi-center clinical trial in China aiming to evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine versus Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\n\nThe anti-PD1 antibody(Camrelizumab) is a humanized monoclonal antibody which can specifically bind to PD-1 and block the interaction between PD-1 and its ligand (PD-L1), allowing T cells to recover the immune response against tumors. It is proved to be effective in certain cancers such as ovarian cancers and certification proved by Chinese Food and Drug Administration(CFDA) includes Hodgkin's lymphoma, non-small cell lung cancer, esophageal cancer and liver cancer."", 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n1. Aged >= 18 years, male or female; 2. Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma; 3. Patients have never received systematical anti-cancer therapy; 4. Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never received local treatment like radiotherapy(The lesion located in previous radiotherapy areas can also be selected as target lesions if the progress confirmed.) 5. ECOG:0-1; 6. Expected survival>=12 weeks; 7. Essential organs function must meet the following criteria (Any blood products, growth factor, leucocyte promoting drugs, platelet promoting drugs, drugs for anemia are not allowed in 14 days before the first use of the experimental medication):\r\n\r\nAbsolute neutrophil count(ANC) >= 1.5x10^9/L\r\nPlatelet >= 85x10^9/L\r\nHemoglobin >= 90g/L\r\nSerum Albumin >= 30g/L\r\nTotal bilirubin <= 2.0 ULN (Biliary obstructive patients after biliary drainage <= 2.5 ULN), AST and ALT <= 3.0 ULN (patients with liver metastasis <= 5 ULN);\r\nCreatinine clearance rate >60 mL/min;\r\nActivated Partial Thromboplastin Time and International Standardized Ratio <= 1.5 ULN (Patients using stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected range of anticoagulants can be selected.)'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT04674956,"{Official Title': 'A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine Versus Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer', 'Brief Summary': 'Aim?Evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\r\n\r\nDrug information?\r\n\r\nanti-PD1 antibody (Camrelizumab)\r\nAG regimens?the standard first-line regimens for metastatic pancreatic cancer.', 'Condition': 'Pancreatic Cancer Stage IV, Pancreatic Cancer Metastatic', 'Detailed Description': ""CPOG1210-07 is a prospective, randomized, double-blinded, multi-center clinical trial in China aiming to evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine versus Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\r\n\r\nThe anti-PD1 antibody(Camrelizumab) is a humanized monoclonal antibody which can specifically bind to PD-1 and block the interaction between PD-1 and its ligand (PD-L1), allowing T cells to recover the immune response against tumors. It is proved to be effective in certain cancers such as ovarian cancers and certification proved by Chinese Food and Drug Administration(CFDA) includes Hodgkin's lymphoma, non-small cell lung cancer, esophageal cancer and liver cancer."", 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n1. Aged >= 18 years, male or female; 2. Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma; 3. Patients have never received systematical anti-cancer therapy; 4. Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never received local treatment like radiotherapy(The lesion located in previous radiotherapy areas can also be selected as target lesions if the progress confirmed.) 5. ECOG:0-1; 6. Expected survival>=12 weeks; 7. Essential organs function must meet the following criteria (Any blood products, growth factor, leucocyte promoting drugs, platelet promoting drugs, drugs for anemia are not allowed in 14 days before the first use of the experimental medication):\r\n\r\nAbsolute neutrophil count(ANC) >= 1.5x10^9/L\r\nPlatelet >= 85x10^9/L\r\nHemoglobin >= 90g/L\r\nSerum Albumin >= 30g/L\r\nTotal bilirubin <= 2.0 ULN (Biliary obstructive patients after biliary drainage <= 2.5 ULN), AST and ALT <= 3.0 ULN (patients with liver metastasis <= 5 ULN);\r\nCreatinine clearance rate >60 mL/min;\r\nActivated Partial Thromboplastin Time and International Standardized Ratio <= 1.5 ULN (Patients using stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected range of anticoagulants can be selected.)'}",{'Arm - Disease - Line of Therapy': 'First-line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05640830,"{Official Title': 'A Phase 1B/2 Study of Trastuzumab, Bevacizumab With Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)\n', 'Brief Summary': 'This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents.\n', 'Condition': 'HER2-positive Advanced Gastric Cancer\n', 'Detailed Description': 'Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHER2-positive advanced gastric cancer\n\nDefined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the CEP17 signal ? 2.0)\nor significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring)\nPatients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer\nPatients who are willing and able to write a written consent form for this trial.\nPatients aged 19 years or older at the time of signing the subject consent form.\nPatients with measurable or evaluable lesions according to RECIST 1.1.\nECOG activity status 0, 1 or 2\nas patients with adequate organ function\n\nAbsolute neutrophil (ANC) ?1.0 x 109/L, platelet ?100 x 109/L, hemoglobin ?9 g/dL, serum creatinine ?1.5 x ULN, total bilirubin ?3.0 mg on laboratory tests within 2 weeks before starting treatment /dL, AST/ALT ?5 x ULN\nEchocardiogram EF ?55% or MUGA scan ?50%'}",{'Arm - Disease - Line of Therapy': 'Second-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05121350,"{Official Title': 'A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma\n', 'Brief Summary': 'A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma\n', 'Condition': 'Soft Tissue Sarcoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\nLife expectancy >=3 months.\nFemale patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.\nUnderstood and signed an informed consent form.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0 -"Line of Therapy Extraction Guideline - -1. Review the �arms data� and identify the line of therapy from the clinical trial arm. - -2. Rely only on ""arms data"" to identify the line of therapy. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. - -3. Make sure to extract only the line of therapy information. - -4. Avoid any other additional context. - -5. Return just the line of therapy. Do not write a para. - -6. Refer to these examples for formatting: Return Line of Therapy - First-Line -",NCT05121350,"{Official Title': 'A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma\n', 'Brief Summary': 'A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma\n', 'Condition': 'Soft Tissue Sarcoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\nLife expectancy >=3 months.\nFemale patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.\nUnderstood and signed an informed consent form.'}",{'Arm - Disease - Line of Therapy': 'First-Line'},0