Ensartinib in Resected ALK-Positive Non-Small-Cell Lung Cancer.

Authors

Dongsheng Yue, Meijuan Huang, Pingping Song, Yuejun Chen, Bin Li, Junke Fu, Jianji Guo, Chao Cheng, Qixun Chen, Shidong Xu, Hongxu Liu, Fang Lv, Jian Hu, Ke Jiang, Weimin Mao, Bo Shen, Feng Ye, Jie Li, Xueying Zhang, Shiping Guo, Bentong Yu, Yuming Zhu, Ming Wu, Wei Zheng, Fang Chen, Zhengfu He, Yuansong Bai, Hua Xin, Keneng Chen, Naiquan Mao, Yu Zhang, Bo Wang, Lei Zhang, Xingwu Chen, Xinyu Mei, Liyun Miao, Runjie Wang, Gaofeng Li, Juntao Yao, Jun Zhao, Chun Chen, Junfeng Liu, Li Wei, Xiaolong Yan, Bo Jin, Xianling Liu, Zhidong Liu, Hui Tian, Wenqun Xing, Lin Yang, Di Ge, Xiangnan Li, Shanqing Li, Yongxiang Song, Aimin Zang, Dahai Zhang, Wu Zhuang, Zijin Liu, Xiaobin Yuan, Tao Fu, Zhilin Shen, Xiaojun Zhang, Qiuyue Cao, Luyang Zhao, Li Mao, Lieming Ding, You Lu, Changli Wang, ELEVATE Study Group

Published in

The New England journal of medicine. Volume 395. Issue 2. Pages 151-161. Jul 09, 2026.

Abstract

Anaplastic lymphoma kinase (ALK) inhibitors have emerged as promising agents for patients with resectable ALK-positive non-small-cell lung cancer (NSCLC). Whether ensartinib, a second-generation ALK inhibitor, is safe and effective in such patients is unknown.
In this phase 3, double-blind, randomized trial involving patients with completely resected, ALK-positive stage IB to IIIB NSCLC after adjuvant chemotherapy, we randomly assigned patients in a 1:1 ratio to receive ensartinib at a dose of 225 mg once daily or placebo for 24 months. The primary end point was disease-free survival in patients with stage II to IIIB NSCLC. The key secondary end point was disease-free survival in the overall patient population.
A total of 274 patients were randomly assigned to receive ensartinib or placebo (137 patients in each group). At 24 months, the percentage of patients with stage II to IIIB disease who were alive and disease-free was 86.4% in the ensartinib group and 53.5% in the placebo group (hazard ratio for disease recurrence or death, 0.20; 95% confidence interval [CI], 0.11 to 0.38; P<0.001). In the overall patient population, the percentage of patients who were alive and disease-free was 87.3% in the ensartinib group and 57.2% in the placebo group (hazard ratio, 0.20; 95% CI, 0.10 to 0.37; P<0.001). Overall survival data were immature. Adverse events of grade 3 or higher occurred in 35.8% of the patients who received ensartinib (most commonly rash) and in 18.2% of those who received placebo.
Among patients with completely resected stage IB to IIIB ALK-positive NSCLC, the percentage of patients who were alive and disease-free at 24 months was significantly higher with ensartinib than with placebo. (Funded by Betta Pharmaceuticals; ELEVATE ClinicalTrials.gov number, NCT05341583.).

PMID:
42418775
Bibliographic data and abstract were imported from PubMed on 09 Jul 2026.

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