- Histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, American Joint Committee on Cancer v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved FISH test, using Vysis® ALK Break apart fluorescence in situ hybridization (FISH) Probe Kit (defined as 15% or more positive tumor cells), or the Ventana® immunohistochemistry (IHC) test, or a ROS1 rearrangement as determined by FISH or reverse transcription polymerase chain reaction (RT-PCR) or Next Generation Sequencing (NGS) via a local diagnostic test (LDT).