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Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial

Zhou, Caicun, Chen, Gongyan, Huang, Yunchao, Zhou, Jianying, Lin, LiZhu, Feng, Jifeng, Wang, Zhehai, Shu, Yongqian +28 more·2021·The Lancet Respiratory Medicine
DOI 10.1016/s2213-2600(20)30365-9
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Abstract

Background Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations; however, there is scarce evidence of the effectiveness of the combinations in the Asian population. We evaluated camrelizumab plus chemotherapy against non-squamous NSCLC in China.Methods We did a randomised, open-label, multicentre, phase 3 trial (CameL) in 52 hospitals in China for patients with non-squamous NSCLC without EGFR and ALK alteration. Eligible patients were aged 18-70 years and had no previous systemic chemotherapy, Eastern Cooperative Oncology Group performance status of 0 or 1, and at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (version 1.1). Patients were randomly assigned (1:1) to receive 4-6 cycles of carboplatin (area under curve 5 mg/mL per min) plus pemetrexed (500 mg/m 2) with or without camrelizumab (200 mg) every 3 weeks, followed by maintenance therapy with camrelizumab plus pemetrexed or pemetrexed alone. Medication was administered intravenously on day 1 of each 3-week treatment cycle. Randomisation was done using a centralised interactive web-response system with the block size randomly generated as four or six and stratified by sex and smoking history. The two primary endpoints were progression-free survival per blinded independent central review, in all patients and in patients who were PD-L1 positive. Primary analysis was done in the full analysis set that included all randomly assigned patients who received at least one dose of the study treatment. Herein, due to the primary endpoint being met at the interim analysis, we reported the findings of prespecified interim analysis, which only included confirmatory statistical testing for progression-free survival in all patients. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT03134872 (follow-up is ongoing).Findings Between May 12, 2017, and June 6, 2018, of the 419 patients who were randomly assigned, seven did not receive assigned treatment and 412 received either camrelizumab plus chemotherapy (n=205) or chemotherapy alone (n=207). At interim analysis, median follow-up duration was 11·9 months (IQR 9·0-14·9). Progression-free survival in this interim analysis was significantly prolonged with camrelizumab plus chemotherapy than with chemotherapy alone (median 11·3 months [95% CI 9·6-15·4] vs 8·3 months [6·0-9·7]; hazard ratio 0·60 [0·45-0·79]; one-sided p=0·0001). Most common grade 3 or worse treatment-related adverse events were decreased neutrophil count (78 [38%] patients in the camrelizumab plus chemotherapy group vs 63 [30%] patients in the chemotherapy alone group), decreased white blood cell count (40 [20%] vs 30 [14%]), anaemia (38 [19%] vs 23 [11%]), and decreased platelet count (34 [17%] vs 24 [12%]). Serious treatment-related adverse events occurred in 74 (36%) patients in the camrelizumab plus chemotherapy group and 27 (13%) patients in the chemotherapy alone group.Interpretation The primary endpoint was met at the interim analysis, showing a statistically significant and clinically meaningful improvement in progression-free survival with camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in all patients, supporting camrelizumab plus carboplatin and pemetrexed as a first-line treatment option for Chinese patients with advanced non-squamous NSCLC without EGFR and ALK alterations. The trial is being continued to collect long-term outcomes in all patients and carry out confirmatory statistical testing for progression-free survival in the PD-L1-positive population.Funding Jiangsu Hengrui Medicine.

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  • In 2020, the NMPA approved camrelizumab plus carboplatin and pemetrexed as the first-line treatment for non-squamous NSCLC, based on the results of CameL.

    “In 2020, the NMPA also approved camrelizumab plus carboplatin and pemetrexed as the first-line treatment for non-squamous NSCLC, based on the results of CameL [61].”

    From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [61]

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Authors
Zhou, C., Chen, G., Huang, Y., Zhou, J., Lin, L., Feng, J., Wang, Z., Shu, Y., Shi, J., Hu, Y., Wang, Q., Cheng, Y., Wu, F., Chen, J., Lin, X., Wang, Y., Huang, J., Cui, J., Cao, L., Liu, Y., Zhang, Y., Pan, Y., Zhao, J., Wang, L., Chang, J., Chen, Q., Ren, X., Zhang, W., Fan, Y., He, Z., Fang, J., Gu, K., Dong, X., Zhang, T., Shi, W., & Zou, J.
Affiliations
  • Tongji University (CN)
  • Third Affiliated Hospital of Harbin Medical University (CN)
  • Kunming Medical University (CN)
  • First Affiliated Hospital Zhejiang University (CN)
  • First Affiliated Hospital of Guangzhou University of Chinese Medicine (CN)
  • Jiangsu Cancer Hospital (CN)
  • Shandong Tumor Hospital (CN)
  • Jiangsu Province Hospital (CN)
  • Chinese People's Liberation Army (CN)
  • Henan Cancer Hospital (CN)
  • Jilin Province Tumor Hospital (CN)
  • Hunan Cancer Hospital (CN)
  • Union Hospital (CN)
  • Sichuan University (CN)
  • First Affiliated Hospital of Soochow University (CN)
  • First Hospital of Jilin University (CN)
  • University of Science and Technology of China (CN)
  • First Hospital of China Medical University (CN)
  • Zhejiang Cancer Hospital (CN)
  • Peking University Cancer Hospital (CN)
  • First Affiliated Hospital of Zhengzhou University (CN)
  • Fudan University (CN)
  • Fuzhou Pulmonary Hospital of Fujian (CN)
  • Tianjin Medical University Cancer Institute and Hospital (CN)
  • First Affiliated Hospital of Nanchang University (CN)
  • Fujian Provincial Cancer Hospital (CN)
  • First Affiliated Hospital of Anhui Medical University (CN)
  • Wuhan Union Hospital (CN)
  • Jiangsu Hengrui Medicine (China) (CN)
Corresponding author
Zhou, Caicun
ORCID
Venue
The Lancet Respiratory Medicine
Publisher
Elsevier BV
Published
2021-03
Volume
9
Issue
3
Pages
305-314
ISSN
2213-2600 (ISSN-L)
DOI
10.1016/s2213-2600(20)30365-9
OpenAlex
W3111665711
Cited by
483
References
26
Citations by year
2026: 39 · 2025: 66 · 2024: 102 · 2023: 118 · 2022: 107 · 2021: 49 · 2020: 1
FWCI
38.70
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Respiratory Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords
camrelizumab, non-squamous non-small cell lung cancer, carboplatin, pemetrexed, immune checkpoint inhibitors, PD-L1, progression-free survival, maintenance therapy, chemotherapy-naive patients, Asian patients, treatment-related adverse events, chemoimmunotherapy, interim analysis
MeSH terms
Pemetrexed, Progression-Free Survival, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, China, Female, Humans, Lung Neoplasms, Male, Middle Aged, Single-Blind Method, Carboplatin, Antibodies, Monoclonal, Humanized, Administration, Intravenous

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