Table 1 Completed immunotherapy clinical trials in ES-SCLC
Phase | Study | Treatment arms | Patients (n) | ORR (%) | PFS (months) | OS (months) |
|---|---|---|---|---|---|---|
First line | ||||||
 II | NCT01331525 | Ipilimumab + carboplatin + cisplatin; maintained with ipilimumab | 42 | 72.4 | 6.9 | 17.0 |
 II | CA184-041 | Ipilimumab/placebo + carboplatin + paclitaxel vs. placebo/ipilimumab + carboplatin + paclitaxel vs. placebo + carboplatin + paclitaxel; maintained with ipilimumab vs. placebo | 128 | 32 vs. 57 vs. 49 | 5.7 vs. 6.4 vs. 5.3* (HR = 0.75, 0.64) (P = 0.11, 0.03) | 9.1 vs. 12.9 vs. 9.9 (HR = 0.95, 0.75) (P = 0.41, 0.13) |
 III | CA184-156 | Ipilimumab + etoposide + cisplatin/carboplatin vs. placebo + etoposide + cisplatin/carboplatin; maintained with ipilimumab vs. placebo | 954 | 62 vs. 62 | 4.6 vs. 4.4 (HR = 0.85) (P = 0.016) | 11 vs. 10.9 (HR = 0.94) (P = 0.38) |
 III | Impower-133 | Atezolizumab + carboplatin + etoposide vs. placebo + carboplatin + etoposide; maintained with atezolizumab vs. placebo | 403 | 60.2 vs. 64.4 | 5.2 vs. 4.3 (HR = 0.77) (P = 0.02) | 12.3 vs. 10.3 (HR = 0.70) (P = 0.007) |
Maintenance | ||||||
 II | NCT02359019 | Pembrolizumab | 45 | 11.1 | 1.4 | 9.6 |
Relapsed | ||||||
 I/II | CheckMate-032 | Nivolumab 3 mg/kg vs. nivolumab 1 mg/kg + ipilimumab 3 mg/kg vs. nivolumab 3 mg/kg + ipilimumab 1 mg/kg | 213 | 10 vs. 23 vs. 19 | 1.4 vs. 2.6 vs. 1.4 | 4.4 vs. 7.7 vs. 6.0 |
 IB | KEYNOTE-028 | Pembrolizumab | 24 | 33.3 | 1.9 | 9.7 |
 II | KEYNOTE-158 | Pembrolizumab | 107 | 18.7 | 2.0 | 9.1 |
 I/II | NCT02261220 | Durvalumab + tremelimumab | 30 | 13.3 | 1.8 | 7.9 |