机构：[a]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China[b]Department of Medical Oncology-Chest (1), Hunan Cancer Hospital, Changsha, People’s Republic of China[c]Respiratory Department, Northern Jiangsu People’s Hospital, Yangzhou, People’s Republic of China江苏省人民医院[d]Department of Medical Oncology, Jilin Cancer Hospital, Changchun, People’s Republic of China[e]First Ward of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, People’s Republic of China[f]Department of Chemotherapy Oncology, Anhui Provincial Hospital, Hefei, People’s Republic of China[g]Department of Medical Oncology, Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, People’s Republic of China[h]Department of Oncology, Henan Cancer Hospital, Zhengzhou, People’s Republic of China河南省肿瘤医院[i]Department of Thoracic Surgery, Yunnan Cancer Hospital and the Third Affiliated Hospital of Kunming Medical University and Yunnan Cancer Centre, Kunming, People’s Republic of China[j]Department of Thoracic Oncology, Sichuan Provincial Cancer Hospital, Chengdu, People’s Republic of China四川省肿瘤医院[k]Department of Medical Oncology, Anhui Chest Hospital, Hefei, People’s Republic of China[l]Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China[m]Department of Respiratory Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, People’s Republic of China[n]The 3rd departement of Medical Oncology, Shaanxi Provincial Cancer Hospital, Xi’an, People’s Republic of China[o]Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, People’s Republic of China[p]Department of Oncology, Jiangsu Province Hospital, Nanjing, People’s Republic of China江苏省人民医院[q]Internal Medicine Ward 2, LinYi Cancer Hospital, Linyi, People’s Republic of China[r]Second Department of Radiotherapy and Chemotherapy, Tangshan People’s Hospital, Tangshan, People’s Republic of China[s]Oncology Department, The Third Xiangya Hospital of Central South University, Changsha, People’s Republic of China[t]Department of Medical Oncology, Chongqing University Cancer Hospital, Chongqing, People’s Republic of China[u]The Second Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing, People’s Republic of China[v]The Second Department of Thoracic Oncology, Jiangxi Cancer Hospital, Nanchang, People’s Republic of China[w]Oncology Department, Baoji Central Hospital, Baoji, People’s Republic of China[x]Department of Respiratory Medicine, Jinan Central Hospital, Jinan, People’s Republic of China[y]Department of Breath Internal Medicine, Taizhou Hospital of Zhejiang Province, Taizhou, People’s Republic of China台州恩泽医疗中心(集团)台州医院[z]Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, People’s Republic of China浙江省肿瘤医院[aa]Department of Internal Medicine-Oncology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, People’s Republic of China[bb]Department of Medical Oncology, Henan Provincial People’s Hospital, Zhengzhou, People’s Republic of China[cc]Department of Medicine, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, People’s Republic of China
Introduction: Camrelizumab, a humanized immunoglobulin G4-kappa monoclonal antibody against programmed cell death protein 1, has exhibited antitumor activity and tolerability across various tumors, including lung cancers. We conducted this double-blind, randomized phase 3 trial to investigate the efficacy and safety of camrelizumab or placebo plus chemotherapy as first-line treatment for patients with advanced squamous NSCLC. The predictive value of circulating tumor DNA (ctDNA) dynamics was also analyzed. Methods: CameL-sq, a double-blind, randomized phase 3 trial (NCT03668496), was conducted in 53 centers in the People's Republic of China. A total of 389 patients with stage IIIB-IV squamous NSCLC were randomized (1:1) to receive 4 to 6 cycles of carboplatin plus paclitaxel with camrelizumab or placebo (every 3 wk), followed by maintenance therapy with camrelizumab or placebo. Peripheral blood ctDNA samples were collected at baseline and the time after two cycles of treatment. Results: Of 389 eligible patients, 193 patients allocated camrelizumab plus chemotherapy and 196 patients allocated placebo plus chemotherapy were included in the efficacy and safety analysis. The results revealed significantly prolonged progression-free survival (median, 8.5 vs. 4.9 mo; p <0.0001) and overall survival (median, not reached vs. 14.5 mo; p <0.0001) with camrelizumab chemotherapy versus placebo-chemotherapy. No unexpected treatment immune-related adverse events were observed in both groups. Biomarker analysis revealed that ctDNA clearance after two cycles of treatment was independently associated with dramatically longer progression-free survival (p <0.0001) and overall survival (p <0.0001) in camrelizumab plus chemotherapy group. Conclusions: Our findings support camrelizumab plus chemotherapy as a first-line treatment option in advanced squamous NSCLC. On-treatment ctDNA dynamics exhibited the potency to predict the efficacy of camrelizumab plus chemotherapy. (C) 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
基金：
This study was funded by Jiangsu Hengrui Pharmaceuticals,
which participated in study design, data collection,
data analysis, and data interpretation. All authors had
full access to all the data in the study, and the corresponding
authors had final responsibility for the decision
to submit for publication. This study was also supported,
in part, by grants from the National Natural Science
Foundation of People’s Republic of China (No. 81871865,
81874036, and 81972167), the Backbone Program of
Shanghai Pulmonary Hospital (No. FKGG1802), Shanghai
Pujiang Talent Plan (No. 2019PJD048), Shanghai Science
and Technology Committee Foundation (NO.
19411950300), Program of Shanghai Academic Research
Leader (NO. 21XD1423200), and Shanghai Key disciplines
of Respiratory (No. 2017ZZ02012).
第一作者机构：[a]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China
共同第一作者：
通讯作者：
通讯机构：[a]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China[*1]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No. 507, Zhengmin Road, Shanghai 200433, People’s Republic of China.
推荐引用方式(GB/T 7714)：
Shengxiang Ren,Jianhua Chen,Xingxiang Xu,et al.Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial[J].JOURNAL OF THORACIC ONCOLOGY.2022,17(4):544-557.doi:10.1016/j.jtho.2021.11.018.
APA：
Shengxiang Ren,Jianhua Chen,Xingxiang Xu,Tao Jiang,Ying Cheng...&Caicun Zhou.(2022).Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial.JOURNAL OF THORACIC ONCOLOGY,17,(4)
MLA：
Shengxiang Ren,et al."Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial".JOURNAL OF THORACIC ONCOLOGY 17..4(2022):544-557
医学