Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Inclusion Criteria: * Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic * treatment-naïve or have received no more than 3 systemic treatment regimen(s) * Positive for translocation or inversion events involving the ROS1 gene * Negative for translocation or inversion events involving the ALK gene * Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications * Any prior treatment (chemotherapy, radiation \[except for palliative\], or surgery) must have been completed at least 2 weeks prior to initiation of study medication * At least 1 measurable tumor lesion as per RECIST v1.1 * Female or male, 18 years of age or older * ECOG performance status 0 to 1 * Adequate organ function * Signed and dated informed consent * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures * Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment Exclusion Criteria: * Current treatment on another therapeutic clinical trial * Prior therapy specifically directed against ALK or ROS1 fusion genes * Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomening…