02711nam a2200301   4500001000800000005001700008007000300025008004100028040000800069041000800077100003400085245006900119300002300188520177300211650003001984650002402014650003002038650003802068700002702106700002702133700002502160700002002185700002202205700002402227773011002251942003102361999001702392ESSALUD20260804150724.0ta      t        pe ||||| |||| 00| 0 spa d  aBMG  aeng  aYue, Dongsheng eAutor953711  aEnsartinib in resected ALK-positive non–small-cell lung cancer  apáginas: 151-161  aBackground: 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.
  aCANCER DE PULMÓN953712  aNEUMOLOGÍA925628  aCUIDADOS INTENSIVOS95208  aTRATAMIENTO EN ONCOLOGÍA953713  aHuang, Meijuan 953714  aSong, Pingping 953715  aChen, Yuejun 953716  aLi, Bin 953717  aFu, Junke 953718  aGuo, Jianji 9537190 022717922635dMassachusetts NEJM GroupoNEJM002tThe New England Journal of Medicine wESSALUDx0028-4793  cARTICULOSe2026-07-30zsqb  c22732d22732