Table 1.
Key clinical trials of immune checkpoint inhibitors in extensive stage of small-cell lung cancer (ES-SCLC).
| Trial | Phase | Treatment Arms | Patients | ORR (%) | PFS (Months) | OS (Months) |
|---|---|---|---|---|---|---|
| Second line and beyond | ||||||
| CheckMate 032 (2016) [12] | I/II | Nivolumab 3 mg/kg v. Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg vs. Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | 216 | 10 vs. 23 vs. 19 | 1.4 vs. 2.6 vs. 1.4 | 4.4 vs. 7.7 vs. 6.0 |
| KEYNOTE 028 (2017) [13] | IB | Pembrolizumab | 24 | 33.3 | 1.9 | 9.7 |
| KEYNOTE 158 (2018) [14] | II | Pembrolizumab | 107 | 18.7 | 2.0 | 9.1 |
| First line | ||||||
| IMpower 133 (2018) [15,16] | III | 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; 95%CI: 0.62–0.96; p = 0.02 *) |
12.3 vs. 10.3 (HR: 0.70; 95%CI: 0.54–0.91; p = 0.007 *) |
| CASPIAN (2019) [17] | III | Durvalumab ± tremelimumab + platinum-etoposide vs. platinum-etoposide; maintained with durvalumab | 805 | 79.5 vs. 70.3 | 5.1 vs. 5.4 (HR: 0.78; 95%CI: 0.65–0.94) |
13.0 vs. 10.3 (HR: 0.73; 95%CI: 0.59–0.91; p = 0.0047 *) |
| CA184–156 (2016) [18] | III | Ipilimumab + platinum-etoposide vs. platinum-etoposide + placebo; maintained with ipilimumab vs. placebo | 1132 | 62 vs. 62 | 4.6 vs. 4.4 (HR: 0.85; 95%CI: 0.75–0.97, p = 0.016) |
11.0 vs. 10.9 (HR: 0.94; 95%CI: 0.81–1.09, p = 0.3775) |
| KEYNOTE-604 (2018) [19] | III | Pembrolizumab + platinum-etoposide vs. placebo + platinum-etoposide; maintained with pembrolizumab vs. placebo | 453 | 70.6 vs. 61.8 | 4.5 vs. 4.3 (HR: 0.75; 95%CI: 0.61–0.91; p = 0.0023 *) |
10.8 vs. 9.7 (HR: 0.80; 95%CI: 0.64–0.98; p = 0.0164 †) |
ORR: objective response rate, PFS: progression-free survival, OS: overall survival, HR: hazard ratio, CI: confidence interval. * significant results. † significance threshold was not met.