Table 3. Ongoing studies on combination of ICIs and chemotherapy and (or) radiotherapy in SCLC.
| ICIs | Chemotherapy/radiotherapy/chemo-radiotherapy | Clinical trial | Phase | Stage | Status | Estimated study completion | Primary outcome measures |
|---|---|---|---|---|---|---|---|
| Combination with chemotherapy | |||||||
| Nivolumab | Irinotecan | NCT04173325 | Phase I | Unknown | Recruiting | Nov-21 | AEs |
| Nivolumab | EC | NCT03382561 | Phase II | ES | Active, not recruiting | 2-Jun-20 | PFS |
| Nivolumab | Temozolomide | NCT03728361 | Phase II | Stage IV | Recruiting | 31-Dec-21 | ORR |
| Nivolumab | Gemcitabine | NCT03662074 | Phase II | Stage IV | Recruiting | 10-Sep-21 | Radiographic RR |
| Durvalumab | Placebo | NCT03703297 | Phase III | LS | Recruiting | 19-Feb-24 | PFS, OS |
| Durvalumab | Olaparib | NCT02734004 | Phase I/II | Unknown | Recruiting | 5-Aug-22 | DCR, ORR |
| Durvalumab | EC | NCT03043872 | Phase III | ES | Active, not recruiting | 30-Sep-20 | OS |
| Durvalumab + Tremelimumab | EC | NCT03043872 | Phase III | ES | Active, not recruiting | 30-Sep-20 | OS |
| Pembrolizumab | Topotecan | NCT02963090 | Phase II | Unknown | Active, not recruiting | 20-Aug-19 | PFS |
| Pembrolizumab | Amrubicin | NCT03253068 | Phase II | ES | Recruiting | 31-Aug-20 | OS |
| Pembrolizumab | EC | NCT03066778 | Phase III | ES | Active, not recruiting | 5-Oct-21 | PFS, OS |
| Pembrolizumab | EC | NCT02580994 | Phase II | ES | Active, not recruiting | Aug-20 | PFS |
| Pembrolizumab | Cisplatin + Pemetrexed/Carboplatin + Paclitaxel/EC/EC + G-CSF | NCT01840579 | Phase I | ES | Active, not recruiting | 30-Jun-20 | DLTs, AEs |
| Atezolizumab + Tiragolumab | EC + Placebo | NCT04256421 | Phase III | ES | Recruiting | 31-Aug-23 | PFS, OS |
| Atezolizumab | EC + Placebo | NCT03041311 | Phase II | ES | Active, not recruiting | May-20 | Chemotherapy-induced myelosuppression |
| Atezolizumab | EC | NCT04028050 | Phase III | ES | Recruiting | 30-Dec-22 | SAEs, Serious and Non-Serious Immune Related Adverse Events |
| Atezolizumab | EC | NCT02763579 | Phase III | ES | Active, not recruiting | 30-Dec-20 | PFS, OS |
| Atezolizumab | EC | NCT04221529 | Phase II | ES | Recruiting | Jun-24 | OS |
| Avelumab | EC | NCT03568097 | Phase II | Unknown | Recruiting | Aug-21 | 1-year PFS |
| Combination with radiotherapy | |||||||
| Nivolumab | Lutathera | NCT03325816 | Phase I/II | ES | Active, not recruiting | Dec-20 | PFS |
| Nivolumab | Stereotactic radiosurgery | NCT02978404 | Phase II | Stage IV | Recruiting | Jun-21 | PFS |
| Nivolumab + Ipilimumab | Stereotactic body radiation therapy | NCT03223155 | Phase I | Stage IV | Recruiting | Dec-20 | SAEs |
| Durvalumab + Tremelimumab | Stereotactic body radiation therapy | NCT02701400 | Phase II | Unknown | Active, not recruiting | Oct-21 | PFS, ORR |
| Atezolizumab | Hypofractionated radiation therapy | NCT03262454 | Phase II | Unknown | Recruiting | 31-Jul-24 | ORR |
| Combination with chemo-radiotherapy | |||||||
| Nivolumab + Ipilimumab | Thoracic radiation therapy + platinum-based chemotherapy | NCT03043599 | Phase I/II | ES | Active, not recruiting | Apr-22 | PFS |
| Durvalumab | EC + thoracic radiotherapy | NCT03585998 | Phase II | LS | Recruiting | 19-Dec-21 | PFS |
| Durvalumab | Olaparib pill + thoracic radiotherapy or Tremelimumab + thoracic radiotherapy | NCT03923270 | Phase I | ES | Recruiting | 1-May-25 | SAEs, PFS |
| Durvalumab or Durvalumab + Tremelimumab | EC + external beam radiation | NCT03509012 | Phase I | ES | Recruiting | 4-Apr-22 | DLTs, AEs |
| Pembrolizumab | EC + radiation | NCT02934503 | Phase II | ES | Recruiting | Oct-20 | PD-L1 expression status, PFS, OS, RR |
| Pembrolizumab | EC + radiation | NCT02402920 | Phase I | LS | Recruiting | 31-Jul-23 | MTD |
| Pembrolizumab | EC + radiation | NCT02402920 | Phase I | LS | Recruiting | 31-Jul-23 | MTD |
| Atezolizumab | Chemo-radiotherapy | NCT03540420 | Phase II | LS | Recruiting | Dec-26 | 2-year OS |
| Atezolizumab | EC + intensity-modulated radiation therapy | NCT03811002 | Phase II/III | LS | Recruiting | 28-Dec-26 | PFS, OS |
ICIs, immune checkpoint inhibitors; OS, overall survival; PFS, progression-free survival; EC, cisplatin or carboplatin plus etoposide; LS, limited stage; ES, extensive stage; AEs, adverse events; DCR, disease control rate; DLTs, dose-limiting toxicities; SAEs, serious adverse events; MTD, maximum tolerated dose; ORR, objective response rate; RR, response rate.