Neoadjuvant Camrelizumab Plus Platinum-Based Chemotherapy vs Chemotherapy Alone for Chinese Patients With Resectable Stage IIIA or IIIB (T3N2) Non–Small Cell Lung Cancer

作者：Jie Lei, Jinbo Zhao, Li Gong, Yunfeng Ni, Yongan Zhou, Feng Tian, Honggang Liu, Zhongping Gu, Lijun Huang, Qiang Lü, Xiaoping Wang, Jianyong Sun, Ende Yang, Tao Wang, Daixing Zhong, Jian Wang, Zhengwei Zhao, Zhigang Liu, Cheng Wang, Xiaojing Wang, Guangyan Lei, Xiaolong Yan, Tao Jiang · 发表于：JAMA Oncology · 年份：2023 · DOI：10.1001/jamaoncol.2023.2751 · 被引用次数：105 · 研究领域：Lung Cancer Diagnosis and Treatment、Cancer Immunotherapy and Biomarkers、Lung Cancer Treatments and Mutations

Importance: The benefit of neoadjuvant camrelizumab plus chemotherapy for resectable stage IIIA or IIIB non-small cell lung cancer (NSCLC) remains unknown. Objective: To assess the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy vs chemotherapy alone for patients with resectable stage IIIA or IIIB NSCLC. Design, Setting, and Participants: In this randomized phase 2 clinical trial conducted at 2 hospitals in China, patients aged 18 to 70 years with resectable stage IIIA or IIIB (T3N2) NSCLC were enrolled between April 7, 2020, and January 12, 2022. Interventions: Patients were randomly assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2, and platinum [cisplatin, 75 mg/m2; carboplatin, area under the curve, 5; or nedaplatin, 100 mg/m2]) or chemotherapy alone, followed by surgery after 4 to 6 weeks. Main Outcomes and Measures: The primary end point was the pathologic complete response (pCR) rate. Secondary end points included the major pathologic response (MPR) rate, objective response rate (ORR), event-free survival (EFS), and safety. Disease-free survival (DFS, defined as the time from surgery to disease recurrence or death from any cause) was analyzed post hoc. Efficacy was assessed on a modified intention-to-treat basis. Results: Ninety-four Chinese patients were randomized, and 88 (93.6%; median age, 61 years [IQR, 54-65 years]; 74 men [84.1%]) received allocated neoadjuvant treatment (43 received camrelizumab...