卡瑞利珠单抗联合法米替尼治疗既往治疗过的非小细胞肺癌患者的疗效和安全性：一项单臂II期试验
Efficacy and safety of camrelizumab plus famitinib in patients with previously treated non-small-cell lung cancer: a single-arm, phase II trial.
作者信息
Gao Ming, Zhang Xia, Yan Huan, Zhao Yan, Yuan Fang, Sun Decong, Yang Xuejiao, Ju Yanfang, Wang Lijie, Tao Haitao, Tian Luyuan, Zhao Changhong, Ma Junxun, Hu Yi, Liu Zhefeng
机构信息
Medical School of Chinese PLA, Beijing, China.
Department of Medical Oncology, Senior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.
出版信息
Ther Adv Med Oncol. 2025 Jan 1;17:17588359241311058. doi: 10.1177/17588359241311058. eCollection 2025.
BACKGROUND
For non-small-cell lung cancer (NSCLC) patients who progressed after first-line chemotherapy, immunotherapy targeting programmed cell death (ligand) 1 has shown promising activity. However, the activity is relatively limited in patients harboring epidermal growth factor receptor (EGFR) mutations.
OBJECTIVES
This study aimed to evaluate the efficacy and safety of camrelizumab plus famitinib in previously treated patients with locally advanced and metastatic NSCLC.
DESIGN
A single-center, single-arm, phase II study.
METHODS
Previously treated patients with locally advanced and metastatic NSCLC were enrolled to receive camrelizumab (200 mg, administered intravenously every 3 weeks) and famitinib (20 mg, administered orally once daily). Patients harboring EGFR mutation genes had received at least one EGFR tyrosine kinase inhibitor and no more than two lines of chemotherapy regimen before the enrollment. The other patients had progressed on first-line chemotherapy with or without immunotherapy before the enrollment. The primary endpoint was the objective response rate (ORR) per RECIST v1.1 by the investigator.
RESULTS
Our study encompassed 23 NSCLC patients between October 2019 and October 2022. For all patients, the confirmed ORR was 30.4%, and the disease control rate was 95.7%. The median progression-free survival (PFS) was 6.9 months (95% CI: 4.9 months-not reached). The median overall survival (OS) was not reached. 1- and 2-year OS rates were 85.6% (95% CI: 71.8%-100.0%) and 56.8% (95% CI: 37.7%-85.7%). Especially, for the 6 patients with EGFR genetic aberrations, the confirmed ORR was 33.3%, the median PFS was 10.3 months (95% CI: 1.8-18.8 months), and the median OS was 20.3 months (95% CI: 0.8-39.8 months). The most common grade 3 and above treatment-related adverse events were platelet count decreased, white blood cell count decreased, and hypertension. No unexpected adverse events were reported.
CONCLUSION
Camrelizumab plus famitinib demonstrated encouraging clinical activity with a manageable safety profile in previously treated patients with locally advanced and metastatic NSCLC. The results warranted further validation.
TRIAL REGISTRATION
Chinese Clinical Trial Registry identifier: ChiCTR1900026641.
背景
对于一线化疗后进展的非小细胞肺癌（NSCLC）患者，靶向程序性细胞死亡蛋白1（配体）的免疫疗法已显示出有前景的活性。然而，在携带表皮生长因子受体（EGFR）突变的患者中，该活性相对有限。
目的
本研究旨在评估卡瑞利珠单抗联合法米替尼在既往接受过治疗的局部晚期和转移性NSCLC患者中的疗效和安全性。
设计
一项单中心、单臂、II期研究。
方法
纳入既往接受过治疗的局部晚期和转移性NSCLC患者，接受卡瑞利珠单抗（200mg，每3周静脉注射一次）和法米替尼（20mg，每日口服一次）治疗。携带EGFR突变基因的患者在入组前至少接受过一种EGFR酪氨酸激酶抑制剂治疗，且接受的化疗方案不超过两线。其他患者在入组前一线化疗（无论是否联合免疫治疗）后病情进展。主要终点是研究者根据RECIST v1.1标准评估的客观缓解率（ORR）。
结果
我们的研究纳入了2019年10月至2022年10月期间的23例NSCLC患者。所有患者的确认ORR为30.4%，疾病控制率为95.7%。中位无进展生存期（PFS）为6.9个月（95%CI：4.9个月-未达到）。中位总生存期（OS）未达到。1年和2年OS率分别为85.6%（95%CI：71.8%-100.0%）和56.8%（95%CI：37.7%-85.7%）。特别是，6例有EGFR基因异常的患者，确认ORR为33.3%，中位PFS为10.3个月（95%CI：1.8-18.8个月），中位OS为20.3个月（95%CI：0.8-39.8个月）。最常见的3级及以上治疗相关不良事件为血小板计数降低、白细胞计数降低和高血压。未报告意外不良事件。
结论
卡瑞利珠单抗联合法米替尼在既往接受过治疗的局部晚期和转移性NSCLC患者中显示出令人鼓舞的临床活性，且安全性可控。结果有待进一步验证。
试验注册
中国临床试验注册中心标识符：ChiCTR1900026641。
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