Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

Summary

This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.

Timeline

Start

2018-12-30

Primary completion

2022-10

Completion

2023-12

Outcome

Met primary endpoint

paper hazard ratio 0·72 [95% CI 0·58-0·90]; one-sided p=0·0017. PMID 35576956 ↗

release “在Ⅲ期CAPSTONE-1研究中1，人源化IgG4抗PD-L1单克隆抗体阿得贝利单抗联合化疗一线治疗ES-SCLC的首次分析（数据截止日期：2021年10月8日）显示，联合治疗显著改善OS” hengrui.com ↗

Publications

• Long Y, Wang H, Xie X, Li J, Xu Y, Zhou Y. Updated cost-effectiveness analysis of adebrelimab plus chemotherapy for extensive-stage small cell lung cancer in China. BMJ Open. 2024 Apr 5;14(4):e077090. doi: 10.1136/bmjopen-2023-077090.
• Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adebrelimab	Monoclonal antibody	20 mg/kg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Etoposide	Small molecule	100 mg/m2	Intravenous

Indications