Table 2 Completed clinical trials evaluating the safety and efficacy of immune checkpoint inhibitors in patients with SCLC
From: Current and future therapies for small cell lung carcinoma
Study name | Trial number | Phase | Patients | Strategy | Drugs | N | ORR | Median OS | Median PFS | Safety (grade 3–4) |
|---|---|---|---|---|---|---|---|---|---|---|
IMPOWER133 | NCT02763579 | 3 | ES-SCLC | PD-L1 inhibitor + Chemo | Atezolizumab + Chemo vs. Chemo | 201 vs. 202 | – | 12.3 vs. 10.3 months | 5.2 vs. 4.3 months | 63% vs. 58% |
RATIONALE 206 | NCT03432598 | 2 | ES-SCLC | PD-L1 inhibitor + Chemo | Tislelizumab + Chemo | 17 | 77% | 15.6 months | 6.9 months | 76.5% |
RATIONALE 312 | NCT04005716 | 3 | ES-SCLC | PD-L1 inhibitor + Chemo | Tislelizumab + Chemo vs. Chemo | 457 | 68.3% vs. 61.7% | 15.5 months vs. 13.5 months | 4.8 months vs. 4.3 months | 85.5% vs. 86% |
CheckMate 032 | NCT01928394 | 1/2 | LS/ES-SCLC | PD-1 inhibitor + CTLA-4 inhibitor | Nivolumab + Ipilimumab vs. Ipilimumab | 147 vs. 96 | 11.6% vs. 21.9% | 5.7 vs. 4.7 months | – | 12.9% vs. 37.5% |
CheckMate 451 | NCT02538666 | 3 | ES-SCLC | PD-1 inhibitor + CTLA-4 inhibitor | Nivolumab + Ipilimumab vs. Nivolumab vs. Placebo | 279 vs. 280 vs. 275 | 9.1% vs. 11.5% vs. 4.2% | 9.2 vs. 10.4 vs. 9.6 months | 1.7 vs. 1.9 vs. 1.4 months | (85.6%/52.2%) vs. (60.9%/11.5%) vs. (50.2%/8.4%) |
CheckMate 331 | NCT02481830 | 3 | Relapsed SCLC | PD-1 inhibitor vs. chemo | Nivolumab vs. Chemo | 284 vs. 285 | 13.7% vs. 16.5% | 7.5 vs. 8.4 months | 1.4 vs. 3.8 months | 13.8% vs. 73.2% |
ETOP/IFCT 4–12 STIMULI | NCT02046733 | 2 | LS-SCLC | PD-1 + CTLA-4 inhibitor vs. obsrvation after CRT plus PCI | Nivolumab + Ipilimumab vs. obsrvaton after CRT plus PCI | 78 vs. 75 | – | not reached | 10.7 vs. 14,5 months | 62% vs. 25% |
- | NCT03026166 | 1/2 | ES-SCLC | Rova-T + PD-1 inhibitor or CTLA-4 inhibitor | Rova-T + Nivolumab + Ipilimumab vs. Rova-T + Nivolumab | 42 | – | – | – | Not tolerated |
- | NCT03325816 | 1 | Relapsed ES-SCLC | Chemo + PD-1 inhibitor | Lutathera + Nivolumab | 9 | – | – | – | 55.6% |
KEYNOTE-604 | NCT03066778 | 3 | ES-SCLC | Chemo + PD-1 inhibitor | Pembrolizumab + Chemo vs. Chemo | 228 vs. 225 | 70.6% vs. 61.8% | 10.8 vs. 9.7 months | 4.5 vs. 4.3 months | 76.7% vs. 74.9% |
CAPSTONE-1 | NCT03711305 | 3 | ES-SCLC | Chemo + PD-L1 inhibitor | Chemo + adebrelimab vs. Chemo | 230 vs. 232 | – | 15.3 vs. 12.8 months | 5.8 vs. 5.6 months | 85% vs. 84% |
ASTRUM-005 | NCT04063163 | 3 | ES-SCLC | Chemo + PD-1 inhibitor | Chemo + Serplulimab vs. Chemo | 389 vs. 196 | – | 15.4 vs. 10.9 months | 5.7 vs. 4.3 months | 33.2% vs. 27.6% |
CTR20192538/ETER701 | NCT04234607 | 3 | ES-SCLC | Chemo + anti-Angiogenesis + PD-L1 inhibitor | Chemo + anlotinib + benmelstobart vs. Chemo | 246 vs. 247 | 81.3% vs. 66.8% | 19.3 vs. 11.9 months | 6.9 vs. 4.2 months | 94.3% vs. 89% |
EXTENTORCH | NCT04012606 | 3 | ES-SCLC | Chemo + PD-1 inhibitor | Chemo + Toripalimab vs. Chemo | 213 vs. 219 | 78% vs. 73.1% | 14.6 vs. 13.3 months | 5.8 vs. 5.6 months | 89.6% vs. 89.4% |