Multicenter phase 3 study of ensartinib after resection of ALK-positive non-small cell lung cancer

Ensartinib is a second-generation ALK inhibitor. The multicenter phase 3 ELEVATE trial in China evaluated ensartinib after complete resection of ALK-positive stage IB to IIIB NSCLC and adjuvant chemotherapy. Patients were randomized 1:1 to receive ensartinib 225 mg once daily (n=137) or placebo (n=137) for 24 months. The primary endpoint was disease-free survival in patients with stage II to IIIB NSCLC, with disease-free survival in the overall population as key secondary endpoint. 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 (HR 0.20; p<0.001). In the overall population, the corresponding percentages were 87.3% and 57.2% (HR 0.20; pxtagstartz0.001). Overall survival data were immature. Adverse events of grade 3 or higher occurred in 35.8% of the patients who received ensartinib and 18.2% of those who received placebo. The authors conclude that among patients with completely resected stage IB to IIIB