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NCT03456076 · ClinicalTrials.gov record · last posted 2026-07-15

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started2018-08-16
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from the ClinicalTrials.gov record
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

Protocol amendment history 1 change detected by DataLookout

2026-05-06
minor
Completion pushed: 2026-11-19 → 2031-11-19
Trial Details
NCT Number NCT03456076
Lead Sponsor Hoffmann-La Roche
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 257 participants
Start Date 2018-08-16
Primary Completion 2023-06-26 (estimated)
Study Completion 2031-11-19 (estimated)
Updated on ClinicalTrials.gov 2026-07-15