Crizotinib

An open-label, active-controlled, multinational, randomized trial enrolled 347 patients with ALK-positive, metastatic NSCLC.  Patients were required to have progressed following platinum-based chemotherapy and to have ALK expression in tumor specimens detected by fluorescence in situ hybridization on central laboratory testing.  Patients were randomized to receive either crizotinib 250 mg orally twice daily (n=173) or chemotherapy (n=174). Patients randomized to chemotherapy received pemetrexed (58%) or docetaxel (42%) if they had received prior pemetrexed.  Approximately 64% of patients on the chemotherapy arm subsequently received crizotinib.