Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial.

Abstract

INTRODUCTION:

Camrelizumab, a humanized immunoglobulin G4-κ 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.

• Authors: Shengxiang Ren, Jianhua Chen, Xingxiang Xu, Tao Jiang, Ying Cheng, Gongyan Chen, Yueyin Pan, Yong Fang, Qiming Wang, Yunchao Huang, Wenxiu Yao, Rui Wang, Xingya Li, Wei Zhang, Yanjun Zhang, Sheng Hu, Renhua Guo, Jianhua Shi, Zhiwu Wang, Peiguo Cao, Donglin Wang, Jian Fang, Hui Luo, Yi Geng, Chunyan Xing, Dongqing Lv, Yiping Zhang, Junyan Yu, Shundong Cang, Zeyu Yang, Wei Shi, Jianjun Zou, Caicun Zhou, CameL-sq Study Group
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 17 Issue 4 Pg. 544-557 (04 2022) ISSN: 1556-1380 [Electronic] United States
• PMID: 34923163 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• camrelizumab
• Carboplatin
• Paclitaxel

Topics

• Animals
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Camelus
• Carboplatin
• Carcinoma, Non-Small-Cell Lung (pathology)
• Carcinoma, Squamous Cell (drug therapy)
• Humans
• Lung Neoplasms (pathology)
• Paclitaxel