Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer

Summary

This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum（Cisplatin or Carboplatin） plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer. The purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum（Cisplatin or Carboplatin） plus etoposide in treatment naive extensive stage small cell lung cancer. Participants will receive asigned study treatment until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Timeline

Start

2019-07-23

Primary completion

2023-04-20

Completion

2023-04-20

Outcome

Met primary endpoint

paper Compared with placebo, toripalimab improved investigator-assessed PFS (hazard ratio [HR], 0.67 [95% CI, 0.54-0.82]; P < .001) PMID 39541202 ↗

paper and significantly reduced the risk of death (HR, 0.80 [95% CI, 0.65-0.98]; P = .03). PMID 39541202 ↗

Publications

• Cheng Y, Zhang W, Wu L, Zhou C, Wang D, Xia B, Bi M, Fu X, Li C, Lv D, Zhao Y, Chen G, Yi T, Huang J, Li M, Yang R, Huang X, Wang Y, Zhang M, Pan Y, Sun Y, Hu S, Zhang X, Zhou M, Fang J, Jin F, Liu Y, Li Y, Zhang Z, Hu J, Liu L, Wang R, Li Y, Gu K, Ding C, Fan Q, Zhang G, Chen Y, Jiang L, Zheng WE, Chen S, Huang C, Han Z, Yang H, Wang J, Wang B, Wu H, Bao Y, Li M, Luo X, Gu S, Yu W, Xu K, Zhang S, Yu J. Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial. JAMA Oncol. 2025 Jan 1;11(1):16-25. doi: 10.1001/jamaoncol.2024.5019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Toripalimab	Monoclonal antibody	240 mg	—
Background	Carboplatin	Small molecule	—	—
Background	Cisplatin	Other / unclassified	—	—
Background	Etoposide	Small molecule	—	—

Indications