Phase III Study of Toripalimab Versus Placebo Plus Chemotherapy in Resectable NSCLC

Summary

This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.

Timeline

Start

2020-04-07

Primary completion

2025-06-30

Completion

2025-12-31

Outcome

Met primary endpoint

paper in the toripalimab group compared with 15.1 months (95% CI, 10.6-21.9 months) in the placebo group (hazard ratio, 0.40 [95% CI, 0.28-0.57], P < .001). PMID 38227033 ↗

paper The major pathological response rate (another primary outcome) was 48.5% (95% CI, 41.4%-55.6%) in the toripalimab group compared with 8.4% PMID 38227033 ↗

Publications

• Fang W, Wang Y, Wang W, Wu L, Sun L, Zhang P, Lu S; Neotorch Investigators; Zheng Y, Chen Q, Tan L, Yang L, Mei J, Sun X, Xu S, Shan J, Yang N, Yu D, Chen Y, Yu G, Hu X, Xing L, Wu N, Chen K, Tian H, Zhang X, Liu Y, Zhou M, Fang H, Li S, Ye M, Wu G, Cao L, Jiang J, Zhu K, Kang M, Xu H, Li X, Zhu L, Zhong A, Sun Q, Wang C, Ma H, Cai K, Zhang Y, Zhang X, Hu H, Chen J, Yang Z, Hang X, Zhang W, Huang Y, Hu J, Zhang L, Yao J, Zhang Z, Liu L, Lin D, Zhang J, Chen G, Li Y, Zhu L, Wang W, Xu J, Cao D, Zou J. Surgical Outcomes of Perioperative Toripalimab in Stage III Resectable Non-Small Cell Lung Cancer: Post Hoc Analysis of the Neotorch Randomized Clinical Trial. JAMA Surg. 2026 Jul 15. doi: 10.1001/jamasurg.2026.2711. Online ahead of print.
• Lu S, Zhang W, Wu L, Wang W, Zhang P; Neotorch Investigators; Fang W, Xing W, Chen Q, Yang L, Mei J, Tan L, Sun X, Xu S, Hu X, Yu G, Yu D, Yang N, Chen Y, Shan J, Xing L, Tian H, Zhang X, Zhou M, Fang H, Wu G, Liu Y, Ye M, Cao L, Jiang J, Li X, Zhu L, Li S, Kang M, Zhong A, Chen K, Wu N, Sun Q, Ma H, Cai K, Wang C, Lin G, Zhu K, Zhang Y, Zhang X, Hu H, Zhang W, Chen J, Yang Z, Hang X, Hu J, Huang Y, Zhang Z, Zhang L, Zhang L, Liu L, Lin D, Zhang J, Chen G, Li Y, Zhu L, Wang W, Yu W, Cao D, Keegan P, Yao S. Perioperative Toripalimab Plus Chemotherapy for Patients With Resectable Non-Small Cell Lung Cancer: The Neotorch Randomized Clinical Trial. JAMA. 2024 Jan 16;331(3):201-211. doi: 10.1001/jama.2023.24735.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Toripalimab	Monoclonal antibody	240 mg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Docetaxel	Small molecule	60 mg/m2	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	175 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Indications