1.
正在进行的SCLC免疫治疗相关临床研究(来源: clinicaltrials.gov, 最后更新: 2019.12.25)
Ongoing immunotherapy trials in SCLC (source: clinicaltrials.gov, last accessed: 25th December 2019)
| Study | Arm | Primary endpoint | Design | Stage |
| SCLC: small cell lung cancer; ES-SCLC: extensive stage SCLC; LS-SCLC: limited-stage SCLC; Ipi: Ipilimumab; Durva: Durvalumab; Treme: Tremelimumab; Atezo: Atezolizumab; Nivo: Nivolumab; Pembro: Pembrolizumab; Ave: Avelumab; DCR: disease control rate; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; DLT: dose-limiting toxicities; MTD: maximum tolerated dose; irAEs: immune-related adverse events. | ||||
| First line | ||||
| NCT03066778 | Pembro+ EP/Placebo+EP | PFS/OS | Phase 3, randomized, double-blind | ES-SCLC |
| NCT03811002 | Chemoradiation/Chemoradiation+Atezo | PFS/OS | Phase 2/3, randomized | LS-SCLC |
| PAVE (NCT03568097) | Ave+EP | 1-year PFS rate | Phase 2, single arm | ES-SCLC |
| NCT03382561 | Nivo+EC/EC | PFS | Phase 2, randomized, controlled | ES-SCLC |
| JAVELIN Medley (NCT02554812) | Ave+Utomilumab | DLT/ORR | Phace 1b/2, randomized | ES-SCLC |
| NCT03406715 | Ipi+Nivo+Dendritic cell based p53 vaccine | DCR | Phase 2, single arm | ES-SCLC |
| NCT03041311 | Trilaciclib+Etoposide or Carboplatin or Atezo/ Placebo+Etoposide or Carboplatin or Atezo |
OS/AE | Phase 2, randomized, double-blinded | ES-SCLC |
| Maintenance | ||||
| STIMULI (NCT02046733) | Nivo+Ipi/Observation | PFS/OS | Phase 2, randomized | LS-SCLC |
| ADRIATIC (NCT03703297) | Durva+Placebo/Durva+Treme/Placebo+Placebo | PFS/OS | Phase 3, randomized, double-blind | LS-SCLC |
| NCT03410368 | Autologous natural killer cells/No intervention | PFS | Phase 2, randomized, controlled | ES-SCLC |
| IMPULSE (NCT03568097) | MGN1703/Continous first line therapy | OS | Phase 2, randomized | ES-SCLC |
| ACHILES (NCT03540420) | Atezo/Observation | 2-year survival | Phase 2, randomized | LS-SCLC |
| NCT03585998 | Durva | PFS | Phase 2, single arm | LS-SCLC |
| NCT03554473 | M7824/M7824+Topotecan/M7824+Temozolomide | Efficacy | Phase 2, non-randomized | ES-SCLC |
| Second line or beyond | ||||
| NCT03059667 | Atezo/Topotecan or EC | ORR | Phase 2, randomized, non-comparative | ES-SCLC |
| NCT03811379 | Toripalimab | ORR | Phase 2, single arm | ES-SCLC |
| NCT03761914 | Galinpepimut-S+Pembro | ORR | Phase 1/2, non-comparative, multi-arm | ES-SCLC |
| NCT03228667 | ALT-803+Pembro/Nivo/Atezo/Ave | ORR | Phase 2b, non-randomized, single arm | ES-SCLC |
| NCT03575793 | Nivol+Ipi/Plinabulin+Nivo+Ipi | MTD/PFS | Phase 1/2, randomized | ES-SCLC |
| NCT03728361 | Nivol+Temozolomide | ORR | Phase 2, single arm | ES-SCLC |
| NCT03994744 | Sintilimab+Metformin | ORR/Safety | Phase 2, single arm | ES-SCLC |
| NCT04192682 | Anlotinib+Sintilimab | PFS | Phase 2/3, single arm | ES-SCLC |
| NCT04055792 | Sintilimab+Anlotinib/Anlotinib | PFS | Phase 2, randomized, controlled | ES-SCLC |
| NCT03093688 | Infusion of iNKT cells and CD8+ T cells | irAEs/ORR | Phase 1/2, single arm | ES-SCLC |