Shuyu Ji, Zhenxin Sheng, Dongliang Bian, Minwei Bao, Kaiqi Jin, Wentian Zhang, Xinsheng Zhu, Fenghuan Sun, Haoran Xia, Han Zhang, Ziyun Shen, Huansha Yu, Lele Zhang, Jie Huang, Zhang Peng, Nan Song, Haifeng Wang, Biyun Qian, Yuming Zhu
{"title":"Neoadjuvant camrelizumab plus chemotherapy or apatinib for resectable stage IIA-IIIA NSCLC: a multicenter, two-arm, phase II exploratory trial.","authors":"Shuyu Ji, Zhenxin Sheng, Dongliang Bian, Minwei Bao, Kaiqi Jin, Wentian Zhang, Xinsheng Zhu, Fenghuan Sun, Haoran Xia, Han Zhang, Ziyun Shen, Huansha Yu, Lele Zhang, Jie Huang, Zhang Peng, Nan Song, Haifeng Wang, Biyun Qian, Yuming Zhu","doi":"10.1186/s12916-025-04250-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This study aimed to evaluate the efficacy and safety of camrelizumab, an anti-PD-1 antibody, combined with either chemotherapy or apatinib, a VEGFR-2 inhibitor, as neoadjuvant treatment for stage IIA-IIIA NSCLC.</p><p><strong>Methods: </strong>This prospective, multicenter, dual-arm, non-randomized phase II trial enrolled participants from four hospitals in China between September 2020 and March 2022. Patients received 2-4 cycles of neoadjuvant treatment followed by surgery. Arm-AR (n = 28) included patients treated with camrelizumab (200 mg every 3 weeks) plus platinum-based chemotherapy, regardless of PD-L1 status. Arm-BR (n = 10) included PD-L1-positive patients treated with camrelizumab (200 mg every 3 weeks) plus apatinib (250 mg daily). The primary endpoint was the major pathological response (MPR) rate. Secondary endpoints included pathological complete response (pCR) rate, objective response rate (ORR), disease control rate (DCR), event-free survival (EFS), overall survival (OS), and safety profiles.</p><p><strong>Results: </strong>In the ITT population, MPR rates were 25.0% (95% CI 10.7-44.9) in arm-AR and 60.0% (95% CI 26.2-87.8) in arm-BR. The 24-month EFS rates were 53.6% and 70.0%, respectively, after a median follow-up of 30.5 months. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 25% of arm-AR patients and 10% of arm-BR patients.</p><p><strong>Conclusions: </strong>Camrelizumab combined with platinum-based chemotherapy demonstrated promising efficacy and tolerability for resectable IIA-IIIA NSCLC, regardless of PD-L1 status. In PD-L1-positive patients, camrelizumab plus apatinib showed improved safety and effectiveness, highlighting a potential treatment option for this subgroup.</p><p><strong>Trial registration: </strong>NCT04379739, initiated on July 26, 2020.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"429"},"PeriodicalIF":7.0000,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12916-025-04250-4","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: This study aimed to evaluate the efficacy and safety of camrelizumab, an anti-PD-1 antibody, combined with either chemotherapy or apatinib, a VEGFR-2 inhibitor, as neoadjuvant treatment for stage IIA-IIIA NSCLC.
Methods: This prospective, multicenter, dual-arm, non-randomized phase II trial enrolled participants from four hospitals in China between September 2020 and March 2022. Patients received 2-4 cycles of neoadjuvant treatment followed by surgery. Arm-AR (n = 28) included patients treated with camrelizumab (200 mg every 3 weeks) plus platinum-based chemotherapy, regardless of PD-L1 status. Arm-BR (n = 10) included PD-L1-positive patients treated with camrelizumab (200 mg every 3 weeks) plus apatinib (250 mg daily). The primary endpoint was the major pathological response (MPR) rate. Secondary endpoints included pathological complete response (pCR) rate, objective response rate (ORR), disease control rate (DCR), event-free survival (EFS), overall survival (OS), and safety profiles.
Results: In the ITT population, MPR rates were 25.0% (95% CI 10.7-44.9) in arm-AR and 60.0% (95% CI 26.2-87.8) in arm-BR. The 24-month EFS rates were 53.6% and 70.0%, respectively, after a median follow-up of 30.5 months. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 25% of arm-AR patients and 10% of arm-BR patients.
Conclusions: Camrelizumab combined with platinum-based chemotherapy demonstrated promising efficacy and tolerability for resectable IIA-IIIA NSCLC, regardless of PD-L1 status. In PD-L1-positive patients, camrelizumab plus apatinib showed improved safety and effectiveness, highlighting a potential treatment option for this subgroup.
Trial registration: NCT04379739, initiated on July 26, 2020.
期刊介绍:
BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.