Surgical Outcomes of Perioperative Toripalimab in Stage III Resectable Non-Small Cell Lung Cancer: Post Hoc Analysis of the Neotorch Randomized Clinical Trial.

Authors

Wentao Fang, Yiyang Wang, Wenxiang Wang, Lin Wu, Longhua Sun, Peng Zhang, Shun Lu, Neotorch Investigators, Yan Zheng, Qixun Chen, Lijie Tan, Lin Yang, Jiandong Mei, Xiaohong Sun, Shidong Xu, Jinlu Shan, Nong Yang, Dongliang Yu, Yuping Chen, Guohua Yu, Xiaohua Hu, Ligang Xing, Nan Wu, Keneng Chen, Hui Tian, Xun Zhang, Yunpeng Liu, Ming Zhou, Haohui Fang, Shanqing Li, Minhua Ye, Guowu Wu, Lejie Cao, Jie Jiang, Kunshou Zhu, Mingqiang Kang, Haipeng Xu, Xingya Li, Liangming Zhu, Aihong Zhong, Qian Sun, Changli Wang, Haitao Ma, Kaican Cai, Yu Zhang, Xiaochun Zhang, Hong Hu, Jun Chen, Zhixiong Yang, Xiaosheng Hang, Wengang Zhang, Yunchao Huang, Jian Hu, Liwei Zhang, Jian Yao, Zhiye Zhang, Lunxu Liu, Dongmei Lin, Jie Zhang, Gang Chen, Yuan Li, Lei Zhu, Weihua Wang, Jing Xu, Dezhen Cao, Jianjun Zou

Published in

JAMA surgery. Jul 15, 2026. Epub Jul 15, 2026.

Abstract

Perioperative immunotherapy has improved clinical outcomes for patients with early-stage non-small cell lung cancer (NSCLC). The influence of immune checkpoint inhibitor in combination with chemotherapy on surgical outcomes remains to be explored.
To evaluate perioperative toripalimab in combination with chemotherapy on surgical outcomes.
This multicenter, double-blind, placebo-controlled phase 3 randomized clinical trial (Neotorch study) enrolled patients with resectable stage III NSCLC and took place at 50 centers in China. Patients who had histologically confirmed resectable stage IIIA or IIIB NSCLC were eligible. These data were analyzed from July 2024 to March 2026.
Patients were randomized (1:1) to receive toripalimab (240 mg) plus platinum-based chemotherapy or placebo plus platinum-based chemotherapy for 3 cycles before surgery and 1 cycle after surgery, followed by maintenance with toripalimab or placebo alone for 13 cycles.
Surgical outcomes, including perioperative complications, tumor downstaging, and lymph node downstaging, and their association with event-free survival (EFS), were studied in this post hoc analysis.
Among 404 patients enrolled, 314 patients (median [SD] age 60 [6.82] years; 90% of patients were male and 10% were female) underwent surgery (166 in toripalimab group and 148 in placebo group). Percentage of patients canceling surgery (17.8% vs 26.7%; P = .03) was significantly lower in the toripalimab group. Proportions of minimally invasive surgery, R0 resection, and lobectomy were slightly higher in the toripalimab group. Surgical complications were similar between the 2 groups. Rates of postsurgery tumor (80.7% vs 50.7%; P < .001) and lymph node downstaging (67.5% vs 48.6%; P = .001) were both significantly higher with toripalimab than placebo. With a median follow-up of 18.3 months, a better EFS was noticed in the toripalimab group. Tumor and lymph node downstaging in the toripalimab group were both associated with better EFS than nondownstaging (median EFS, not estimable [NE] vs 17.5 months; P = .004 and NE vs 19.2 months; P = .001, respectively), and were also associated with even better EFS than tumor and lymph node downstaging in the placebo group (median EFS, NE vs 22.0 months; P = .002 and NE vs NE; P = .009, respectively).
In this study, perioperative toripalimab plus chemotherapy showed comparable perioperative outcomes, as with chemotherapy alone without new safety signals, and could help improve survival through effective tumor downstaging in patients with resectable stage III NSCLC.
ClinicalTrials. gov Identifier: NCT04158440.

PMID:
42455561
Bibliographic data and abstract were imported from PubMed on 15 Jul 2026.

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