Efficacy and safety of finotonlimab plus docetaxel vs. docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial

作者：Baohui Han, Lin Wu, Runxiang Yang, Hongbo Wu, Xing Li, Yan Yu, Mingjuan Zhang, Hongmei Sun, Tianqing Chu, Fukuan Zhong, Yong Fang, Rong Wu, Tao Bian, Xiaoqing Guo, Meili Sun, Yanming Zhang, Lianke Liu, Xuewen Liu, Yueyin Pan, Ou Jiang, Zonghui Wei, Haifeng Lin, Wei Guo, Jian Fang, Jialei Wang, Cuimin Ding, Yanping Hu, Feng Ye, Wu Zhuang, Shucheng Ye, Lihong Wang, Zhe Huang, Chang Liu, Ling Yang, Jinling Wang, Liangzhi Xie · 发表于：Translational Lung Cancer Research · 年份：2025 · DOI：10.21037/tlcr-24-1042 · 被引用次数：5 · 研究领域：Lung Cancer Treatments and Mutations、Cancer Immunotherapy and Biomarkers、Lung Cancer Research Studies

Background: Lung cancer is the most common cancer in the world, and non-small cell lung cancer (NSCLC) constitutes about 80-85%. In this phase III trial, we evaluate the efficacy and safety of anti-programmed cell death-1 (PD-1) monoclonal antibody (SCT-I10A) plus docetaxel compared to docetaxel in patients with previously treated advanced squamous cell NSCLC (sqNSCLC). Methods: Patients were randomized 2:1 to finotonlimab plus docetaxel group (finotonlimab plus docetaxel) and docetaxel group (placebo plus docetaxel) for up to 6 cycles, followed by maintenance monotherapy with finotonlimab/placebo. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS) as well as assessments of safety and immunogenicity. Results: There were 188 eligible patients enrolled (finotonlimab plus docetaxel group: n=126; docetaxel group: n=62). Median OS (mOS) was 17.1 months [95% confidence interval (CI): 11.2, 20.0] in the finotonlimab plus docetaxel group and 10.4 months (95% CI: 5.9, 14.0) in the control group. Hazard ratio (HR) was 0.66 (95% CI: 0.45, 0.96; P=0.03). Median PFS (mPFS) was 4.2 months (95% CI: 3.3, 6.9) and 2.9 months (95% CI: 1.5, 3.8) respectively in the finotonlimab plus docetaxel group and control group. Patients in the finotonlimab plus docetaxel group achieved an ORR of 27.0% (95% CI: 19.5%, 35.6%), which was significantly higher than th...