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A Phase 3 Study of Serplulimab Plus Chemotherapy as First-Line Treatment for Squamous Non-small-Cell Lung Cancer (ASTRUM-004)

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作者：
Zhou, C.[1] * ; Hu, Y.[2] ; Arkania, E.[3] ; Kilickap, S.[4] ; Ying, K.[5] ; Xu, F.[6] ; Wu, L.[7] ; Wang, X.[8] ; Viguro, M.[9] ; Makharadze, T.[10,11] ; Sun, H.[1] ; Luo, F.[12] ; Shi, J.[13] ; Zang, A.[14] ; Pan, Y.[15] ; Chen, Z.[16] ; Jia, Z.[17] ; Kuchava, V.[18] ; Lu, P.[19] ; Zhang, L.[6] ; Cheng, Y.[20] ; Li, W.[21] ; Kang, W.[21] ; Wang, Q.[21] ; Yang, G.[21] ; Yu, H.[21] ; Li, J.[21] ; Zhu, J.[21] ;
机构： [1]Shanghai Pulm Hosp, Shanghai, Peoples R China [2]Hubei Canc Hosp, Wuhan, Peoples R China [3]LTD Israeli Georgian Med Res Clin Helsicore, Tbilisi, Georgia [4]Hacettepe Univ, Fac Med, Ankara, Turkiye [5]Zhejiang Univ, Sch Med, Sir Run Run Shaw Hosp, Hangzhou, Peoples R China [6]Nanchang Univ, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China [7]Cent South Univ, Xiangya Sch Med, Hunan Canc Hosp, Affiliated Canc Hosp, Changsha, Peoples R China [8]Xuzhou Cent Hosp, Xuzhou, Jiangsu, Peoples R China [9]Med Ctr Mriya Med Serv, Kryvyi, U Arab Emirates [10]LTD High Technol Hosp MedCtr, Batumi, Georgia [11]Jiamusi Canc Hosp, Jiamusi, Peoples R China [12]Sichuan Univ, West China Hosp, Chengdu, Peoples R China [13]Linyi Canc Hosp, Linyi, Shandong, Peoples R China [14]Hebei Univ, Affiliated Hosp, Baoding, Peoples R China [15]Univ Sci & Technol China, Anhui Prov Hosp, Affiliated Hosp 1, Hefei, Peoples R China [16]Anhui Med Univ, Affiliated Hosp 2, Hefei, Peoples R China [17]Linyi Peoples Hosp, Linyi, Shandong, Peoples R China [18]LTD Inst Clin Oncol, Tbilisi, Georgia [19]Xinxiang Med Univ, Affiliated Hosp 1, Xinxiang, Henan, Peoples R China [20]Jilin Canc Hosp, Changchun, Peoples R China [21]Shanghai Henlius Biotech Inc, Shanghai, Peoples R China
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关键词： serplulimab squamous non-small-cell lung cancer phase 3

摘要：
Introduction: Historically, treatment for squamous non-small-cell lung cancer (sNSCLC) was mostly based on chemotherapy. Adding PD-1/PDL1 inhibitor to chemotherapy has demonstrated improved efficacy over chemotherapy alone in first-line treatment of unselected patient population with advanced or metastatic sNSCLC. However, preferred treatment options with a favorable benefit-risk ratio are still limited for advanced sNSCLC in the global setting. Here we report the results from a phase 3 study of serplulimab (a novel anti-PD-1 antibody) plus chemotherapy (carboplatin and nab-paclitaxel) in patients with locally advanced or metastatic sNSCLC who have not received previous systemic treatment. Methods: In this randomized, double-blind, international multicenter phase 3 study, patients with histologically or cytologically confirmed stage IIIB/IIIC or IV sNSCLC and no prior systemic therapy were randomized 2:1 to receive intravenous serplulimab 4.5 mg/kg or placebo (up to 35 cycles) in combination with chemotherapy (carboplatin and nab-paclitaxel, 4-6 cycles) in 3-week cycles.

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出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
JCR分区：
出版当年[2023]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM
最新[2023]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Shanghai Pulm Hosp, Shanghai, Peoples R China
推荐引用方式(GB/T 7714)：
Zhou C.,Hu Y.,Arkania E.,et al.A Phase 3 Study of Serplulimab Plus Chemotherapy as First-Line Treatment for Squamous Non-small-Cell Lung Cancer (ASTRUM-004)[J].JOURNAL OF THORACIC ONCOLOGY.2023,18(11):S63-S64.
APA：
Zhou, C.,Hu, Y.,Arkania, E.,Kilickap, S.,Ying, K....&Zhu, J..(2023).A Phase 3 Study of Serplulimab Plus Chemotherapy as First-Line Treatment for Squamous Non-small-Cell Lung Cancer (ASTRUM-004).JOURNAL OF THORACIC ONCOLOGY,18,(11)
MLA：
Zhou, C.,et al."A Phase 3 Study of Serplulimab Plus Chemotherapy as First-Line Treatment for Squamous Non-small-Cell Lung Cancer (ASTRUM-004)".JOURNAL OF THORACIC ONCOLOGY 18..11(2023):S63-S64

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