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. 2020 Mar 20;23(3):182–188. [Article in Chinese] doi: 10.3779/j.issn.1009-3419.2020.03.08

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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