Ensartinib in Resected ALK-Positive Non–Small-Cell Lung Cancer
Published July 8, 2026
N Engl J Med 2026;395:151-161
DOI: 10.1056/NEJMoa2518990
Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
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.)
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Notes
A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
Supported by Betta Pharmaceuticals.
Disclosure forms provided by the authors are available with the full text of this article.
We thank all the patients and their families, all the trial site coordinators, and the ELEVATE trial independent data monitoring committee. Hangzhou Astrocyte Technology provided the immunohistochemical assay for anaplastic lymphoma kinase.
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History
Published online: July 8, 2026
Published in issue: July 9, 2026
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