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Mutations in the anaplastic lymphoma kinase (ALK) gene occur in about 5% of patients with non–small-cell lung cancer (NSCLC). These patients are more likely than those with other types of NSCLC to be aged ≤55 years, to be never smokers, and to develop central nervous system (CNS) metastases. Alectinib is currently approved for the first-line treatment of advanced ALK-positive NSCLC.
The industry-supported, international, open-label, phase 3 ALINA trial assessed the efficacy and safety of 24 months of adjuvant alectinib versus platinum-based chemotherapy in 257 patients with completely resected stage IB to IIIA ALK-positive NSCLC. The primary endpoint was disease-free survival (DFS). Patients were randomized to receive oral alectinib (600 mg …