A Study of CS1001 in Subjects With Stage III Non-Small Cell Lung Cancer

Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of CS1001 in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Timeline

Start

2018-10-26

Primary completion

2023-04-03

Completion

2023-04-03

Outcome

Met primary endpoint

paper Progression-free survival assessed by BICR was significantly longer with sugemalimab than with placebo PMID 35038429 ↗

paper stratified hazard ratio 0·64 [95% CI 0·48-0·85], p=0·0026 PMID 35038429 ↗

Publications

• Zhou Q, Chen M, Jiang O, Pan Y, Hu D, Lin Q, Wu G, Cui J, Chang J, Cheng Y, Huang C, Liu A, Yang N, Gong Y, Zhu C, Ma Z, Fang J, Chen G, Zhao J, Shi A, Lin Y, Li G, Liu Y, Wang D, Wu R, Xu X, Shi J, Liu Z, Cui N, Wang J, Wang Q, Zhang R, Yang J, Wu YL. Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced, unresectable, stage III non-small-cell lung cancer in China (GEMSTONE-301): interim results of a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):209-219. doi: 10.1016/S1470-2045(21)00630-6. Epub 2022 Jan 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sugemalimab	Monoclonal antibody	1200 mg	Intravenous

Indications