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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

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收录情况： ◇ SCIE

作者：
Han, Baohui[1] * ; Wu, Lin[2] ; Yang, Runxiang[3] ; Wu, Hongbo[4] ; Li, Wei[5] ; Yu, Yan[6] ; Zhang, Mingjuan[7] ; Sun, Hongmei[8] ; Chu, Tianqing[1] ; Zhong, Fukuan[9] ; Fang, Yong[10] ; Wu, Rong[11] ; Bian, Tao[12] ; Guo, Xiaoqing[13] ; Sun, Meili[14] ; Zhang, Yanming[15] ; Liu, Lianke[16] ; Liu, Xuewen[17] ; Pan, Yueyin[18] ; Jiang, Ou[19] ; Wei, Zonghui[20] ; Lin, Haifeng[21] ; Guo, Wei[22] ; Fang, Jian[23] ; Wang, Jialei[24] ; Ding, Cuimin[25] ; Hu, Yanping[26] ; Ye, Feng[27] ; Zhuang, Wu[28] ; Ye, Shucheng[29] ; Wang, Lihong[30] ; Huang, Zhe[31] ; Liu, Chang[31] ; Yang, Ling[31] ; Wang, Jinling[31] ; Xie, Liangzhi[31] ;
机构： [1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Resp Dept, Sch Med, Shanghai 200030, Peoples R China [2]Hunan Canc Hosp, Thorac Med Oncol Dept, Changsha, Peoples R China [3]Yunnan Canc Hosp, Dept Med Oncol 2, Kunming, Yunnan, Peoples R China [4]Zhengzhou Univ, Affiliated Canc Hosp, Henan Canc Hosp, Dept Hlth Management Ctr, Zhengzhou, Peoples R China [5]First Affiliated Hosp, Dept Resp Dis, Bengbu Med Coll, Bengbu, Anhui, Peoples R China [6]Harbin Med Univ, Canc Hosp, Dept Med Oncol, Harbin, Peoples R China [7]Weihai Municipal Hosp, Dept Gynecol, Weihai, Peoples R China [8]Jiamusi Tumor Hosp, Dept Med Oncol, Jiamusi 154007, Peoples R China [9]Second Peoples Hosp Lianyungang, Dept Hepatobiliary Surg, Lianyungang, Peoples R China [10]Sir Run Run Shaw Hosp, Coll Med, Dept Neurosurg, Hangzhou, Peoples R China [11]Shengjing Hosp China Med Univ, Dept Oncol, Shenyang, Peoples R China [12]Wuxi Peoples Hosp, Dept Resp & Crit Care Med, Wuxi, Peoples R China [13]Ganzhou Peoples Hosp, Dept Oncol, Ganzhou, Peoples R China [14]Shandong First Med Univ, Cent Hosp Affiliated, Dept Neurol, Jinan, Peoples R China [15]Linfen Cent Hosp, Linfen Clin Med Res Ctr, 17,Jiefang West Rd, Linfen 041000, Shanxi, Peoples R China [16]Jiangsu Prov Hosp, Dept Oncol, Nanjing, Peoples R China [17]Third Xiangya Hosp Cent South Univ, Dept Gynecol, Changsha, Peoples R China [18]First Affiliated Hosp USTC, Ward 5, Dept Tumor Chemotherapy, Hefei, Peoples R China [19]Second Peoples Hosp Neijiang, Dept Cardiol, Neijiang, Peoples R China [20]Peoples Hosp Nanchuan, Dept Nephrol, Chongqing, Peoples R China [21]Second Affiliated Hosp Hainan Med Univ, Dept Neurol, Haikou 570216, Peoples R China [22]Shanxi Prov Canc Hosp, Dept Resp Dis, Taiyuan 030013, Shanxi, Peoples R China [23]Beijing Canc Hosp, Dept Urol, Beijing, Peoples R China [24]Fudan Univ, Shanghai Canc Ctr, Dept Med Oncol, Shanghai, Peoples R China [25]Fourth Hosp Hebei Med Univ, Dept Rheumatol & Immunol, Shijiazhuang, Peoples R China [26]Hubei Canc Hosp, Dept Thorac Oncol, Wuhan, Peoples R China [27]First Affiliated Hosp Xiamen Univ, Dept Radiat Oncol, Xiamen, Peoples R China [28]Fujian Canc Hosp, Dept Med Oncol, Fuzhou, Fujian, Peoples R China [29]Jining Med Univ, Affiliated Hosp, Oncol Dept, Jining, Peoples R China [30]Inner Mongolia Med Univ, Affiliated Hosp, Dept Resp Med, Hohhot, Peoples R China [31]Sinocelltech Ltd, Beijing Engn Res Ctr Prot & Antibody, Beijing, Peoples R China
出处：
DOI： 10.21037/tlcr-24-1042
ISSN：

关键词： Finotonlimab docetaxel squamous cell non-small cell lung cancer (sqNSCLC)

摘要：
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 the 3.2% (95% CI: 0.4%, 11.2%) in the control group. The DCR was 68.3% (95% CI: 59.4%, 76.3%) in the finotonlimab plus docetaxel group and 56.5% (95% CI: 43.3%, 69.0%) in the control group. Treatment-related adverse events (TRAEs) occurred in 91.3% (115/126) patients of finotonlimab plus docetaxel group and 87.1% (54/62) patients of control group. Conclusions: SCT-I10A combined with docetaxel significantly prolonged OS and improved clinical outcomes in patients with treated advanced sqNSCLC compared to docetaxel, without increasing safety risk. Trial Registration: NCT04171284, ClinicalTrials.gov.

基金：
National Science and Technology Major Projects of China [2019ZX09732-001]; Sinocelltech Ltd.
语种：
外文
WOS：
PubmedID：
中科院分区：
出版当年[2025]版：
大类 | 3 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
最新[2025]版：
大类 | 3 区 医学
小类 | 3 区 肿瘤学 3 区 呼吸系统
JCR分区：
出版当年[2024]版：
Q1 RESPIRATORY SYSTEM Q2 ONCOLOGY
最新[2024]版：
Q1 RESPIRATORY SYSTEM Q2 ONCOLOGY

影响因子： 最新[2024版] 最新五年平均 出版当年[2025版] 出版当年五年平均 出版前一年[2024版]

第一作者：
第一作者机构： [1]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Resp Dept, Sch Med, Shanghai 200030, Peoples R China
通讯作者：
推荐引用方式(GB/T 7714)：
Han Baohui,Wu Lin,Yang Runxiang,et al.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[J].TRANSLATIONAL LUNG CANCER RESEARCH.2025,14(4):doi:10.21037/tlcr-24-1042.
APA：
Han, Baohui,Wu, Lin,Yang, Runxiang,Wu, Hongbo,Li, Wei...&Xie, Liangzhi.(2025).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.TRANSLATIONAL LUNG CANCER RESEARCH,14,(4)
MLA：
Han, Baohui,et al."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".TRANSLATIONAL LUNG CANCER RESEARCH 14..4(2025)

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