OncoMatch/Clinical Trials/Alectinib

Alectinib (Alecensa) Clinical Trials

Alectinib (Alecensa, RO5424802) is a highly selective, CNS-penetrant second-generation ALK inhibitor that demonstrated superiority over crizotinib in the Phase 3 ALEX trial, establishing itself as a standard first-line option for ALK-positive advanced NSCLC. The Phase 3 ALINA trial subsequently showed that adjuvant alectinib significantly reduced the risk of recurrence or death in patients with resected stage IB–IIIA ALK-positive NSCLC, earning FDA approval in the adjuvant setting in April 2024 — the first ALK inhibitor approved for early-stage disease. Active trials explore alectinib combinations with immunotherapy for treatment-naive advanced disease, as well as strategies for post-alectinib progression. Eligibility requires confirmed ALK rearrangement by an approved test; adjuvant trials specify surgical resection, pathologic staging (stage IB tumors must be ≥4 cm), and confirmed ALK rearrangement.