Surgery after induced anti-PD-L1 therapy and chemotherapy for stage I‒III small-cell lung cancer: a phase 2 trial (LungMate-005)

Immunochemotherapy has shown promising outcomes in treating small-cell lung cancer. To explore whether surgery after immunochemotherapy benefits patients with stage I‒III small-cell lung cancer, we conducted a phase II trial (NCT04539977). Eligible patients received four cycles of anti-PD-L1 antibody (TQB2450) therapy and chemotherapy, followed by surgery or radiotherapy and one-year maintenance immunotherapy (TQB2450). Forty patients were enrolled between December 2020 and January 2023. Thirty-eight (95.0%) patients had stage III disease. We found that the objective response rate, as the primary endpoint of this study, was 92.5% (95% CI: 83.9%‒100%) in the intention-to-treat population. At a median follow-up of 25.8 months, the median event-free survival (EFS) was 16.2 months. The median overall survival (OS) was not reached. The major pathological response and pathological complete response rate of operative patients (n = 21) were 61.9% and 42.9%, respectively. The 24-month EFS and 24-month OS of operative patients were 61.9% and 85.7%, respectively. All patients with N1 disease (n = 9) underwent surgery, with the 24-month EFS of 66.7% and 24-month OS of 88.9%. The most common TQB2450-specific adverse event was rash of grade 1‒2 (12.5%). We further explored the biomarker of immunochemotherapy and molecular changes during immunochemotherapy through bulk-RNA sequencing and whole-exome sequencing. We demonstrated that PRSS8 was a potential biomarker for poor effectiveness of immunochemotherapy. In conclusion, surgery after neoadjuvant immunochemotherapy is feasible for treating patients with stage I‒III small-cell lung cancer.

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Publication Details

Journal
Cell Discovery
Published
2025-11-25
DOI
https://doi.org/10.1038/s41421-025-00838-5
Primary Topic
Lung Cancer Research Studies
Type
article
Field-Weighted Citation Impact
0.00

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article

Surgery after induced anti-PD-L1 therapy and chemotherapy for stage I‒III small-cell lung cancer: a phase 2 trial (LungMate-005)

Liang Duan, Chang Chen, Jun Ma, Yong Yang et al.
Cell Discovery
Lung Cancer Research Studies
article

Surgery after induced anti-PD-L1 therapy and chemotherapy for stage I‒III small-cell lung cancer: a phase 2 trial (LungMate-005)

Liang Duan, Chang Chen, Jun Ma, Yong Yang, Wenxin He, Deping Zhao, Dongliang Bian, Shuyan Meng, Huansha Yu, Yirui Zhou, Nan Song, Lixin Wang, Ming Liu, Peng Zhang, Xiaogang Liu, Di Wang, Cong Ye, Xiaoxiong Xu, Lele Zhang, Jie Luo, Liangdong Sun, Jie Yang, Bin Chen, Zhaoxia Dai, Junjie Hu, Fenghuan Sun, Gening Jiang, Yilv Yan
article en

Abstract

Immunochemotherapy has shown promising outcomes in treating small-cell lung cancer. To explore whether surgery after immunochemotherapy benefits patients with stage I‒III small-cell lung cancer, we conducted a phase II trial (NCT04539977). Eligible patients received four cycles of anti-PD-L1 antibody (TQB2450) therapy and chemotherapy, followed by surgery or radiotherapy and one-year maintenance immunotherapy (TQB2450). Forty patients were enrolled between December 2020 and January 2023. Thirty-eight (95.0%) patients had stage III disease. We found that the objective response rate, as the primary endpoint of this study, was 92.5% (95% CI: 83.9%‒100%) in the intention-to-treat population. At a median follow-up of 25.8 months, the median event-free survival (EFS) was 16.2 months. The median overall survival (OS) was not reached. The major pathological response and pathological complete response rate of operative patients (n = 21) were 61.9% and 42.9%, respectively. The 24-month EFS and 24-month OS of operative patients were 61.9% and 85.7%, respectively. All patients with N1 disease (n = 9) underwent surgery, with the 24-month EFS of 66.7% and 24-month OS of 88.9%. The most common TQB2450-specific adverse event was rash of grade 1‒2 (12.5%). We further explored the biomarker of immunochemotherapy and molecular changes during immunochemotherapy through bulk-RNA sequencing and whole-exome sequencing. We demonstrated that PRSS8 was a potential biomarker for poor effectiveness of immunochemotherapy. In conclusion, surgery after neoadjuvant immunochemotherapy is feasible for treating patients with stage I‒III small-cell lung cancer.

Cell DiscoveryVol. 11(1)
Tongji University (CN), Dalian Medical University (CN), Second Affiliated Hospital of Dalian Medical University (CN), Shanghai Pulmonary Hospital (CN)
National Natural Science Foundation of China, Shanghai Municipal Education Commission, Tongji University, Shanghai Pulmonary Hospital
Openalex Percentile: Top 50%
Lung Cancer Research Studies
DOIOpen Access PDFOpenAlex
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