3. Disease progression during or after treatment with one or two treatment regimen(s). Treatment regiments can be chemotherapy or immunotherapy for advanced (Stage IIIB) or metastatic disease (Stage IV). Modification of regimen to manage toxicity with a different drug does not constitute a new regimen. Maintenance therapy following platinum-based chemotherapy is not considered as a separate regimen. Adjuvant chemotherapy and/or chemoradiation for early stage disease do not count as prior chemotherapy. Prior radiation and/or PD-1/PD-L1 immunotherapy is not exclusionary. Prior treatment for advanced or metastatic disease must have included a platinum-based regimen.