Perioperative Toripalimab Plus Chemotherapy for Patients With Resectable Non–Small Cell Lung Cancer

• DOI: 10.1001/jama.2023.24735
• Publication Date: 2024-01-16T16:02:04Z
• Authors: Shun Lu; Wei Zhang; Lin Wu; Wenxiang Wang; Peng Zhang; ; Wentao Fang; Wenqun Xing; Qixun Chen; Lin Yang; Jiandong Mei; Lijie Tan; Xiaohong Sun; Shidong Xu; Xiaohua Hu; Guohua Yu; Dongliang Yu; Nong Yang; Yuping Chen; Jinlu Shan; Ligang Xing; Hui Tian; Xun Zhang; Ming Zhou; Haohui Fang; Guowu Wu; Yunpeng Liu; Minhua Ye; Lejie Cao; Jie Jiang; Xingya Li; Liangming Zhu; Shanqing Li; Mingqiang Kang; Aihong Zhong; Keneng Chen; Nan Wu; Qian Sun; Haitao Ma; Kaican Cai; Changli Wang; Gen Lin; Kunshou Zhu; Yu Zhang; Xiaochun Zhang; Hong Hu; Wengang Zhang; Jun Chen; Zhixiong Yang; Xiaosheng Hang; Jian Hu; Yunchao Huang; Zhiye Zhang; Lumin Zhang; Liwei Zhang; Lunxu Liu; Dongmei Lin; Jie Zhang; Gang Chen; Yuan Li; Lei Zhu; Weihua Wang; Wenbo Yu; Dezhen Cao; Patricia Keegan; Sheng Yao
• Keywords: Interim analysis

Importance Adjuvant and neoadjuvant immunotherapy have improved clinical outcomes for patients with early-stage non–small cell lung cancer (NSCLC). However, the optimal combination of checkpoint inhibition chemotherapy remains unknown. Objective To determine whether toripalimab in platinum-based will improve event-free survival major pathological response stage II or III resectable NSCLC compared alone. Design, Setting, Participants This randomized trial enrolled (without EGFR ALK alterations nonsquamous NSCLC) from March 12, 2020, to June 19, 2023, at 50 participating hospitals China. The data cutoff date this interim analysis was November 30, 2022. Interventions Patients were a 1:1 ratio receive 240 mg placebo once every 3 weeks combined cycles before surgery 1 cycle after surgery, followed by only (240 mg) up 13 cycles. Main Outcomes Measures primary (assessed investigators) rate blinded, independent review). secondary included complete review) adverse events. Results Of 501 randomized, 404 had (202 + group 202 group) 97 excluded analysis. median age 62 years (IQR, 56-65 years), 92% male, follow-up 18.3 months 12.7-22.5 months). For outcome survival, length not estimable (95% CI, 24.4 months-not estimable) 15.1 10.6-21.9 months) (hazard ratio, 0.40 [95% 0.28-0.57], P < .001). (another outcome) 48.5% 41.4%-55.6%) 8.4% 5.0%-13.1%) (between-group difference, 40.2% 32.2%-48.1%], (secondary 24.8% 19.0%-31.3%) 1.0% 0.1%-3.5%) 23.7% 17.6%-29.8%]). incidence immune-related events occurred more frequently group. No unexpected treatment-related toxic effects identified. grade higher events, fatal leading discontinuation treatment comparable between groups. Conclusions Relevance addition perioperative led significant improvement strategy manageable safety profile. Trial Registration ClinicalTrials.gov Identifier: NCT04158440