| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| lung cancer (metastatic) | alectinib | 1L | versus crizotinib alectinib superior to crizotinib in terms of PFS in ALEX, 2017 (1L patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ALEX, 2017 | alectinib 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 |
| 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: |
|
| lung cancer (metastatic) | alectinib | 2L | versus chemotherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ALUR, 2018 | alectinib vs chemotherapy | PFS 0.15 [0.08; 0.29] median 9.6 vs. 1.4 | | |
| Trial | Treatments | Patients | Method |
|---|
| 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: |
|
| lung cancer (metastatic) | ceritinib | 1L | versus chemotherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ASCEND-4, 2017 | ceritinib vs chemotherapy | PFS 0.55 [0.42; 0.73] median 16.6 vs. 8.1 | | OS 0.73 [0.50; 1.07] median NR vs. 26.2 |
| Trial | Treatments | Patients | Method |
|---|
| ASCEND-4, 2017 | oral ceritinib 750 mg/day (n=189) vs. platinum-based chemotherapy ([cisplatin 75 mg/m2 or carboplatin AUC 5-6 plus pemetrexed 500 mg/m2] every 3 weeks for four cycles followed by maintenance pemetrexed (n=187) | untreated patients with stage IIIB/IV ALK-rearranged non-squamous NSCLC | open-label Sample size: 189/187 Primary endpoint: pfs FU duration: |
|
| lung cancer (metastatic) | ceritinib | 2L after crizotinib failure | versus chemotherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ASCEND 5, 2017 | ceritinib vs pemetrexed or docetaxel | | | |
| Trial | Treatments | Patients | Method |
|---|
| ASCEND 5, 2017 | Oral LDK378 750 mg once daily (n=-9) vs. pemetrexed or docetaxel (n=-9) | patients previously treated with chemotherapy (platinum doublet) and crizotinib | Sample size: -9/-9 Primary endpoint: PFS FU duration: |
|
| lung cancer (metastatic) | crizotinib | 1L | versus chemotherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PROFILE 1014, 2014 | crizotinib vs chemotherapy | PFS 0.45 [0.34; 0.59] median 10.9 vs. 7.0 mo | | OS 0.82 [0.54; 1.25] median NR vs. NR |
| Trial | Treatments | Patients | Method |
|---|
| 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 |
|
| lung cancer (metastatic) | crizotinib | 2L | versus chemotherapy No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Shaw, 2013 | crizotinib vs chemotherapy | PFS 0.49 [0.37; 0.64] | | OS 1.02 [0.68; 1.53] |
| Trial | Treatments | Patients | Method |
|---|
| 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: |
|
