Anti-PD1 based precision induction therapy in unresectable stage III non-small cell lung cancer: a phase II umbrella clinical trial

Chengxiang Yi, Dongliang Bian, Jue Wang, Shiqi Hu, Liangdong Sun, Yilv Yan, Suyu Wang, Ziyun Shen, Huansha Yu, Yong Yang, Yirui Zhou, Xiaogang Liu, Nan Song, Yuming Zhu, Deping Zhao, Gening Jiang, Liang Duan, Wenxin He, Dong Xie (), Jie Dai (), Lele Zhang () and Peng Zhang ()
Additional contact information
Chengxiang Yi: Tongji University
Dongliang Bian: Tongji University
Jue Wang: Tongji University
Shiqi Hu: The First Affiliated Hospital of Wenzhou Medical University
Liangdong Sun: Tongji University
Yilv Yan: Tongji University
Suyu Wang: Tongji University
Ziyun Shen: Tongji University
Huansha Yu: Tongji University
Yong Yang: Tongji University
Yirui Zhou: Tongji University
Xiaogang Liu: Tongji University
Nan Song: Tongji University
Yuming Zhu: Tongji University
Deping Zhao: Tongji University
Gening Jiang: Tongji University
Liang Duan: Tongji University
Wenxin He: Tongji University
Dong Xie: Tongji University
Jie Dai: Tongji University
Lele Zhang: Tongji University
Peng Zhang: Tongji University

Nature Communications, 2025, vol. 16, issue 1, 1-17

Abstract: Abstract The efficacy and safety of induction-immunotherapy followed by surgery for unresectable Stage III non-small cell lung cancer (NSCLC) remain challenging. In this open-label, single-center, phase II clinical umbrella trial (ChiCTR2000035367), 100 unresectable Stage III NSCLC patients are enrolled. Patients with PD-L1 expression ≥ 50% but contraindications to anti-angiogenic therapy receive immuno-monotherapy. Patients with PD-L1 expression ≥ 1% and no contraindications to anti-angiogenic therapy receive immunotherapy plus anti-angiogenesis therapy. Patients with PD-L1 expression between 1% and 49%, contraindications to anti-angiogenic therapy, or negative/unknown PD-L1 expression receive chemoimmunotherapy. The primary endpoint is the major pathological response (MPR) rate. Among 47 surgically-treated patients, the MPR rate is 61.7% (95% confidence interval [CI]: 46.4%-75.5%), achieving the prespecified endpoint. For secondary endpoints, the objective response rate for all patients is 54.0% (95% CI: 43.7-64.0). The median event-free survival is 29.9 months (95% CI: 17.0-42.7). Most common adverse event is anemia (49.0%). Exploratory transcriptomic analyses reveal Bone Marrow Stromal Cell Antigen 1 (BST1) as a promising biomarker for response to chemoimmunotherapy. Generally, for unresectable stage III NSCLC patients, anti-PD1 based induction-therapy according to PD-L1 expression and contraindication to antiangiogenic therapy followed by surgery is a feasible option.

Date: 2025
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DOI: 10.1038/s41467-025-57184-z

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