Shaw, 2013 | crizotinib (250 mg) twice daily (n=-9) vs. intravenous chemotherapy with either pemetrexed (500 mg per square meter of body-surface area) or docetaxel (75 mg per square meter) every 3 weeks (n=-9) | patients with locally advanced or metastatic ALK-positive lung cancer who had received one prior platinum-based regimen | open-label Parallel groups Sample size: -9/-9 Primary endpoint: PFS FU duration: |
PROFILE 1014, 2014 | oral crizotinib, at a dose of 250 mg twice daily (n=172) vs. Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin (n=171) | patients with advanced ALK-positive nonsquamous NSCLC who had
received no previous systemic treatment for advanced disease | open-label Sample size: 172/171 Primary endpoint: progression-free survival FU duration: 16.7 months |