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A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004)

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机构: [1]Department of Medical Oncology, Shanghai Pulmonary Hospital, Shanghai 200433, China [2]Department of Medical Oncology, Hubei Cancer Hospital, Wuhan 430000, China [3]LTD Israeli-Georgian Medical Research Clinic ‘‘Helsicore’’, Tbilisi 0112, Georgia [4]Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara 06230, Turkey [5]Department of Pneumology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou 310016, China [6]Department of Pneumology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China [7]Department of Thoracic Medical Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410013, China [8]Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou 221009, China [9]Clinical Research Department, Medical Center ‘‘Mriya Med-Service’’, Kryvyi Rih 50000, Ukraine [10]LTD ‘‘High Technology Hospital MedCenter’’, Batumi 6010, Georgia [11]Department of Medical Oncology, Jiamusi Cancer Hospital, Jiamusi 154007, China [12]Lung Cancer Center, West China Hospital of Sichuan University, Chengdu 610041, China [13]Department of Medical Oncology, Linyi Cancer Hospital, Linyi 276000, China [14]Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding 071000, China [15]Department of Medical Oncology, Anhui Provincial Hospital, The First Affiliated Hospital of University of Science and Technology of China, Hefei 230001, China [16]Department of Medical Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230601, China [17]Department of Oncology, Linyi People’s Hospital, Linyi 276002, China [18]LTD Institute of Clinical Oncology, Tbilisi 0159, Georgia [19]Department of Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang 453100, China [20]Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China [21]Department of Oncology, Jilin Cancer Hospital, Changchun 130012, China [22]Shanghai Henlius Biotech, Inc., Shanghai 200233, China [23]Department of Medical Oncology, Istinye University Faculty of Medicine, Istanbul 34010, Turkey
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Combining immunotherapy with chemotherapy can provide improved survival in advanced squamous non-small-cell lung cancer (NSCLC) patients without targetable gene alterations. 537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC without targetable gene alterations were enrolled and randomized (2:1) to receive serplulimab 4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenously in 3-week cycles. The primary endpoint of progression-free survival (PFS) was met at the first interim analysis. At the second interim analysis, PFS benefit was maintained in serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.42-0.67). At the final analysis, serplulimab-chemotherapy significantly improved median OS compared to placebo-chemotherapy (HR 0.73, 95% CI 0.58-0.93; p = 0.010). Grade ≥3 serplulimab or placebo-related adverse events occurred in 126 (35.2%) and 58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimab to chemotherapy significantly improves survival in advanced squamous NSCLC patients, with manageable safety.Copyright © 2023 Elsevier Inc. All rights reserved.

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出版当年[2023]版:
大类 | 1 区 医学
小类 | 1 区 细胞生物学 1 区 肿瘤学
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大类 | 1 区 医学
小类 | 1 区 细胞生物学 1 区 肿瘤学
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出版当年[2023]版:
Q1 CELL BIOLOGY Q1 ONCOLOGY
最新[2023]版:
Q1 CELL BIOLOGY Q1 ONCOLOGY

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[2023版]

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第一作者机构: [1]Department of Medical Oncology, Shanghai Pulmonary Hospital, Shanghai 200433, China
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