Abstract
9008Background: ALC showed promising efficacy and tolerability in the phase I/II study (AF-001JP). Here, we conducted the randomized open-label phase III trial (J-ALEX study, JapicCTI-132316) to prove superior progression-free survival (PFS) of ALC to CRZ in ALK+ NSCLC patients (pts) without prior ALK inhibitor treatment. Methods: ALK+ NSCLC pts were randomized 1:1 either to receive ALC (300 mg b.i.d.) or CRZ (250 mg b.i.d.) and stratified by ECOG PS (0/1 vs 2), treatment line (1st vs 2nd), and clinical stage (IIIB/IV vs recurrence). Treatment on both arms was continued until disease progression or unacceptable toxicity. Primary endpoint was PFS according to the blinded independent review board. Secondary endpoints included overall survival, objective response rate, and safety. Under an assumption of expected hazard ratio (HR) of 0.643, 164 events were required to have 80% power with 2-sided alpha of 0.05. Three interim analyses (IA) for early stopping due to efficacy were planned after 33%, 50%, and 75% ...
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