Table 2. Ongoing studies on combination of ICIs and other immunotherapeutic agents in SCLC.
| PD-1/PD-L1 inhibitors | Other ICIs/other immunotherapeutic agents | Target | Clinical trial | Phase | Stage | Status | Estimated study completion | Primary outcome measures |
|---|---|---|---|---|---|---|---|---|
| Combination of PD-1/PD-L1 inhibitors with other ICIs | ||||||||
| Nivolumab | Ipilimumab | CTLA-4 | NCT03670056 | Phase II | ES | Not yet recruiting | 30-Sep-22 | Change in the ratio of Teff/Treg cells |
| NCT03043599 | Phase I/II | ES | Active, not recruiting | Apr-22 | PFS | |||
| NCT02046733 | Phase II | LS | Active, not recruiting | Jan-22 | OS, PFS | |||
| NCT03083691 | Phase II | All | Enrolling by invitation | Aug-21 | ORR | |||
| NCT02538666 | Phase III | ES | Active, not recruiting | Jun-20 | OS | |||
| NCT02538666 (CheckMate 451) | Phase III | ES | Active, not recruiting | 11-Jun-20 | OS | |||
| Nivolumab or Ipilimumab or Nivolumab + Ipilimumab | INCAGN01876 | GITR | NCT03126110 | Phase I/II | Unknown | Recruiting | 28-Oct-21 | AEs, ORR |
| INCAGN01949 | OX40 | NCT03241173 | Phase I/II | Unknown | Completed | 23-Nov-19 | TEAEs, ORR | |
| Durvalumab | Tremelimumab | CTLA-4 | NCT03703297 | Phase III | LS | Recruiting | 19-Feb-24 | PFS and OS |
| NCT02937818 | Phase II | ES | Active, not recruiting | 22-Jan-21 | Overall Response Rate | |||
| NCT03923270 | Phase I | ES | Recruiting | 1-May-25 | SAEs, PFS | |||
| NCT02701400 | Phase II | Unknown | Active, not recruiting | Oct-21 | PFS, ORR | |||
| NCT03043872 | Phase III | ES | Active, not recruiting | 30-Sep-20 | OS | |||
| NCT03509012 | Phase I | ES | Recruiting | 4-Apr-22 | DLTs, AEs | |||
| Pembrolizumab | Ipilimumab | CTLA-4 | NCT01840579 | Phase I | ES | Active, not recruiting | 30-Jun-20 | DLTs, AEs |
| XmAb®22841 | CTLA-4 x LAG-3 | NCT03849469 | Phase I | Unknown | Recruiting | Mar-27 | AEs | |
| INCAGN01876+ Epacadostat | GITR+IDO1 | NCT03277352 | Phase I/II | Unknown | Active, not recruiting | May-20 | TEAEs, ORR, CRR | |
| Epacadostat | IDO1 | NCT03361228 | Phase I/II | Unknown | Completed | 30-Mar-19 | TEAEs, ORR | |
| Atezolizumab | Tiragolumab | TIGIT | NCT04256421 | Phase III | ES | Recruiting | 31-Aug-23 | PFS, OS |
| PDR001 | LAG525 | LAG-3 | NCT03365791 | Phase II | Unknown | Active, not recruiting | 19-Oct-20 | CBR, PFS |
| Avelumab | Utomilumab | CD137 | NCT02554812 | Phase II | Unknown | Recruiting | 16-Dec-22 | Cmax, ADA, TTR, DR, PFS, OS, Tumor tissue biomarkers |
| Combination of ICIs with other immunotherapy agents | ||||||||
| Nivolumab or Pembrolizumab or Atezolizumab or Avelumab | ALT-803 | IL-15 | NCT03228667 | Phase II | Unknown | Recruiting | Aug-20 | ORR |
| Pembrolizumab | SO-C101 | IL-15 | NCT04234113 | Phase I | Unknown | Recruiting | Mar-22 | DLTs, AEs, SAEs, laboratory test abnormalities, Clinically Significant Change and ECOG |
| Atezolizumab | BNT411 | TLR7 | NCT04101357 | Phase I/II | ES | Not yet recruiting | Dec-23 | DLTs, TEAEs, IMP dose reductions, IMP treatment discontinuations due to toxicity |
| Nivolumab | BMS-986012 | fucosyl-GM1 | NCT02247349 | Phase I/II | Unknown | Active, not recruiting | 28-Sep-20 | AEs, worst grade SAEs |
| Pembrolizumab | Galinpepimut-S | Wilms tumor 1 (WT1) protein | NCT03761914 | Phase I/II | Unknown | Recruiting | 30-Jul-21 | TRAEs, Overall response rate |
| Nivolumab + Pembrolizumab + Atezolizumab | FT500 | NK cells | NCT03841110 | Phase I | Unknown | Recruiting | Jun-22 | DLTs |
| Nivolumab + Ipilimumab | INGN-225 (Ad. p53-DC) | Dendritic cell p53 | NCT03406715 | Phase II | LS + ES | Recruiting | Apr-21 | DCR |
ICIs, immune checkpoint inhibitors; OS, overall survival; PFS, progression-free survival; LS, limited stage; ES, extensive stage; AEs, adverse events; DCR, disease control rate; IMP, investigational medicinal products; DLTs, dose-limiting toxicities; SAEs, serious adverse events; MTD, maximum tolerated dose; ORR, objective response rate; RR, response rate; CRR, complete response rate; TEAEs, treatment-emergent adverse events; CBR, clinical benefit rate; Cmax, maximum plasma concentration; ADA, anti-drug antibody; TTR, time to tumor response; DR, duration of response; ECOG, Eastern Cooperative Oncology Group.