02708nam a2200301 4500 ESSALUD 20260804150724.0 ta t pe ||||| |||| 00| 0 spa d BMG eng Yue, Dongsheng Autor 53711 Ensartinib in resected ALK-positive non–small-cell lung cancer páginas: 151-161 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. CANCER DE PULMÓN 53712 NEUMOLOGÍA 25628 CUIDADOS INTENSIVOS 5208 TRATAMIENTO EN ONCOLOGÍA 53713 Huang, Meijuan 53714 Song, Pingping 53715 Chen, Yuejun 53716 Li, Bin 53717 Fu, Junke 53718 Guo, Jianji 53719 22717 22635 Massachusetts NEJM Group NEJM002 The New England Journal of Medicine ESSALUD 0028-4793 ARTICULOS 2026-07-30 sqb 22732 22732