2. Ongoing clinical trials of immune checkpoint inhibitors in SCLC.
| Clinical trial gov. identifier | Phase | Treatment arms | Population | Primary endpoint | Primary completion |
| *, Number of participants experiencing dose-limiting toxicities; SCLC, small cell lung cancer; ED-SCLC, extensive stage small cell lung cancer; LD-SCLC, limited disease small cell lung cancer; PFS, progression-free survival; OS, overall survival; DLT, dose-limiting toxicity; AE, adverse effect; DCR, disease control rate; ORR, objective response rate. | |||||
| First-line | |||||
| REACTION/
NCT02580994 |
II | Pembrolizumab+chemotherapy vs.
chemotherapy |
ED-SCLC | PFS | August 2020 |
| CASPIAN/
NCT03043872 |
III | Durvalumab+tremelimumab+
chemotherapy vs. Durvalumab+chemotherapy vs. chemotherapy |
ED-SCLC | OS | September 30, 2019 |
| STIMULI/
NCT02046733 |
II | chemotherapy followed by nivolumab+ipilimumab vs. chemotherapy | LD-SCLC | OS, PFS | October 2019 |
| KEYNOTE-604/
NCT03066778 |
III | Pembrolizumab+chemotherapy vs. Placebo+chemotherapy | SCLC | PFS, OS | December 16, 2019 |
| KEYNOTE-011/
NCT01840579 |
I | Pembrolizumab vs. pembrolizumab+chemotherapy vs. Pembrolizumab+Ipilimumab vs. Pembrolizumab+chemotherapy+G-CSF | Solid tumor, SCLC, NSCLC | DLTs*, AE | June 30, 2020 |
| Second-line and beyond | |||||
| CheckMate-331/
NCT02481830 |
I/II | Nivolumab vs. chemotherapy topotecan vs. chemotherapy amrubicin | Lung cancer | OS | August 17, 2018 |
| AFT-17/
NCT02963090 |
II | Pembrolizumab vs. topotecan | SCLC | PFS | May 20, 2019 |
| MEDIOLA/
NCT02734004 |
I/II | MEDI4736 (anti-PD-L1 antibody) +Olaparib (PARP inhibitor) | Ovarian, breast, SCLC, gastric cancers | DCR, safety
and tolerability |
August 5, 2022 |
| CA001-030/
NCT02247349 |
II | BMS-986012 (anti-fucosyl-GM1) vs. BMS-986012+nivolumab | SCLC | AE | October 24, 2019 |
| NCT02701400 | II | Tremelimumab+durvalumab vs. Tremelimumab+durvalumab+radiation | Relapsed SCLC | PFS, ORR | January 2020 |
| Maintance treatment | |||||
| CheckMate-451 | III | Nivolumab vs. Nivolumab+ipilimumab vs. placebo | Lung cancer | OS, PFS | October 1, 2018 |