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    • Neoadjuvant SHR-1701 with or Without Chemotherapy in Unresectable Stage III Non-Small-cell Lung Cancer: A Proof-of-concept, Phase 2 Trial

    Qing Zhou,Yi Pan,Xuening Yang,Yanqiu Zhao,Guang Han,Qingsong Pang,Zhenfa Zhang,Qifeng Wang,Jun Yao,Hui Wang,Weihua Yang,Baogang Liu,Qixun Chen,Xianghui Du,Kaican Cai,Baosheng Li,Yunchao Huang, Xiao Li, Li Song, Wei Shi,Yi-Long Wu

    CANCER CELL（2024）

    Guangdong Lung Cancer Institute | Zhengzhou Univ | Department of Radiation Oncology | Tianjin Med Univ Canc Inst & Hosp | Radiotherapy Center | Henan Univ Sci & Technol | Department of Chest Radiotherapy | Shanxi Prov Canc Hosp | Harbin Med Univ | Univ Chinese Acad Sci | Department of Thoracic Radiotherapy | Southern Med Univ | Yunnan Canc Hosp | Jiangsu Hengrui Pharmaceut Co Ltd

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    Abstract
    We conducted a proof-of-concept, phase 2 trial to assess neoadjuvant SHR-1701 with or without chemotherapy, followed by surgery or radiotherapy, and then consolidation SHR-1701 in unresectable stage III non-small-cell lung cancer (NSCLC). In the primary cohort of patients receiving neoadjuvant combination therapy ( n = 97), both primary endpoints were met, with a post-induction objective response rate of 58% (95% confidence interval [CI] 47-68) and an 18-month event-free survival (EFS) rate of 56.6% (95% CI 45.2-66.5). Overall, 27 (25%) patients underwent surgery; all achieved R0 resection. Among them, 12 (44%) major pathological responses and seven (26%) pathological complete responses were recorded. The 18-month EFS rate was 74.1% (95% CI 53.2-86.7) in surgical patients and 57.3% (43.0-69.3) in radiotherapy-treated patients. Neoadjuvant SHR-1701 with chemotherapy, followed by surgery or radiotherapy, showed promising efficacy with a tolerable safety profile in unresectable stage III NSCLC. Surgical conversion was feasible in a notable proportion of patients and associated with better survival outcomes.
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    Key words
    stage III NSCLC,unresectable NSCLC,surgical conversion,neoadjuvant immunotherapy,bispecific antibody,TGF-beta,PD-L1
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    【要点】：本研究是一项概念验证的2期临床试验，评估了在不可切除的III期非小细胞肺癌（NSCLC）患者中使用新辅助SHR-1701联合或不联合化疗，随后进行手术或放疗，再进行巩固SHR-1701治疗的疗效。
    

    【方法】：研究采用新辅助SHR-1701与化疗联合应用，随后患者接受手术或放疗治疗，最后以SHR-1701巩固治疗的方式。
    

    【实验】：在主要队列中（n=97），患者接受新辅助联合治疗后，达到了两个主要终点，诱导后客观响应率为58%，18个月无事件生存率为56.6%。共有27名患者（25%）进行了手术，均实现了R0切除。在手术患者中，有12名（44%）出现主要病理反应，7名（26%）实现病理完全缓解，手术组患者的18个月EFS率为74.1%，放疗组为57.3%。实验使用的数据集为临床试验中患者的疗效和安全性数据。