Cited by 135Lung Cancer Research StudiesLung Cancer Treatments and MutationsLung Cancer Diagnosis and Treatment

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Camrelizumab Plus Apatinib in Extensive-Stage SCLC (PASSION): A Multicenter, Two-Stage, Phase 2 Trial

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Fan, Yun, Zhao, Jun, Wang, Qiming, Huang, Dingzhi, Li, Xingya, Chen, Jianhua, Fang, Yong, Duan, Jianchun, Zhou, Caicun, Hu, Yanping, Yang, Haihua, Hu, Yi, Zhou, Jianying, Lin, Xiaoyan, Wang, Lifeng, Wang, Zhijie, Xu, Yanjun, Zhang, Tao, Shi, Wei, Zou, Jianjun, Wang, Jie·2021·Journal of Thoracic Oncology

DOI 10.1016/j.jtho.2020.10.002

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Abstract

Introduction Treatment options in the second-line extensive-stage SCLC (ED-SCLC) setting are limited. The PASSION study (ClinicalTrials.gov identifier: NCT03417895) was a phase 2 study of camrelizumab plus apatinib in ED-SCLC after platinum-based chemotherapy.Methods In stage I of the study, patients were randomized (1:1:1) to receive camrelizumab 200 mg every 2 weeks plus apatinib 375 mg once daily (QD), 5 days on and 2 days off, or 7 days on and 7 days off (six patients each cohort). On the basis of tolerability during the first 28-day cycle and efficacy data at stage I, one cohort was chosen to expand to 45 patients at stage II. The primary end point was objective response rate (ORR).Results From April 20, 2018 to March 12, 2019, a total of 59 patients were enrolled, with 47 patients in the QD cohort. In the QD cohort, confirmed ORR reached 34.0% (95% confidence interval: 20.9‒49.3), the median progression-free survival was 3.6 months, and the median overall survival was 8.4 months. Chemotherapy-sensitive and chemotherapy-resistant patients (defined as patients with disease relapse at ≥90 and <90 d after platinum-based chemotherapy, respectively) had comparable confirmed ORR (37.5% versus 32.3%), median progression-free survival (3.6 versus 2.7 mo), and median overall survival (9.6 versus 8.0 mo). Treatment-related adverse events of grade 3 or higher were reported in 43 of 59 patients (72.9%). Five patients (8.5%) discontinued because of treatment-related adverse events.Conclusions Camrelizumab plus apatinib exhibited potential antitumor activity in patients with both chemotherapy-sensitive and chemotherapy-resistant ED-SCLC who had failed platinum-based chemotherapy with an acceptable toxicity profile. This phase 2 data warrant further clinical studies of camrelizumab plus apatinib in SCLC.

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Authors: Fan, Y., Zhao, J., Wang, Q., Huang, D., Li, X., Chen, J., Fang, Y., Duan, J., Zhou, C., Hu, Y., Yang, H., Hu, Y., Zhou, J., Lin, X., Wang, L., Wang, Z., Xu, Y., Zhang, T., Shi, W., Zou, J., & Wang, J.
Affiliations: Zhejiang Cancer Hospital (CN)
Peking University Cancer Hospital (CN)
Henan Cancer Hospital (CN)
Tianjin Medical University Cancer Institute and Hospital (CN)
First Affiliated Hospital of Zhengzhou University (CN)
Hunan Cancer Hospital (CN)
Sir Run Run Shaw Hospital (CN)
Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
Tongji University (CN)
Chinese PLA General Hospital (CN)
Zhejiang Taizhou Hospital (CN)
First Affiliated Hospital Zhejiang University (CN)
Union Hospital (CN)
Nanjing Drum Tower Hospital (CN)
Corresponding author: Wang, Jie
ORCID: Fan, Yun
Zhao, Jun
Wang, Qiming
Huang, Dingzhi
Li, Xingya
Chen, Jianhua
Fang, Yong
Duan, Jianchun
Zhou, Caicun
Hu, Yanping
Yang, Haihua
Hu, Yi
Zhou, Jianying
Lin, Xiaoyan
Wang, Lifeng
Wang, Zhijie
Xu, Yanjun
Zhang, Tao
Shi, Wei
Zou, Jianjun
Wang, Jie
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2021-02
Volume: 16
Issue: 2
Pages: 299-309
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1016/j.jtho.2020.10.002
OpenAlex: W3095089286
Cited by: 135
References: 39
Citations by year: 2026: 7 · 2025: 20 · 2024: 35 · 2023: 22 · 2022: 30 · 2021: 19
FWCI: 6.50
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 365 d)
Locations: Journal of Thoracic Oncology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: camrelizumab, apatinib, extensive-stage small cell lung cancer, second-line therapy, PD-1 inhibitors, anti-angiogenic therapy, platinum-based chemotherapy, objective response rate, progression-free survival, overall survival, treatment-related adverse events
MeSH terms: Humans, Lung Neoplasms, Pyridines, Small Cell Lung Carcinoma, Antibodies, Monoclonal, Humanized

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Camrelizumab Plus Apatinib in Extensive-Stage SCLC (PASSION): A Multicenter, Two-Stage, Phase 2 Trial

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