| lung cancer (metastatic) | superior to crizotinib in terms of PFS in ALEX, 2017 (1L patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ALEX, 2017 | vs crizotinib | PFS 0.47 [0.34; 0.65] median NR vs. 11.1 mo Demonstrated | | OS 0.76 [0.48; 1.20] median NR vs. NR | | ALUR, 2018 | vs crizotinib | PFS 0.15 [0.08; 0.29] median 9.6 vs. 1.4 | | |
| Trial | Treatments | Patients | Method |
|---|
| ALEX, 2017 | alectinib 600 mg orally (four 150 mg capsules) BID (n=152) vs. Crizotinib (n=151) | patients with stage IIIB or IV, ALK-positive NSCLC who had not received prior systemic therapy | open label Parallel groups Sample size: 152/151 Primary endpoint: Investigator assessed PFS FU duration: | | ALUR, 2018 | oral alectinib at a dose of 600 milligrams (mg) twice daily (n=-9) vs. chemotherapy with either pemetrexed (500 milligrams per square meter [mg/m^2] of body surface area) or docetaxel (75 mg/m^2) intravenously. (n=-9) | ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib | Parallel groups Sample size: -9/-9 Primary endpoint: PFS FU duration: |
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