Confirmatory data were provided by the randomized phase 3 J-ALEX study (JapicCTI-132316), which compared the efficacy and safety of 300 mg twice-daily alectinib with 250 mg twice-daily crizotinib in ALK inhibitor-naïve Japanese patients with ALK-positive NSCLC, who were chemotherapy naïve or who had received one previous chemotherapy regimen. This evidence concerns the gene ALK and non-small cell lung carcinoma.