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Clinical Trial Summary

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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT03456076
Study type Interventional
Source Hoffmann-La Roche
Contact Reference Study ID Number: BO40336
Phone 888-662-6728 (U.S. and Canada)
Status Recruiting
Phase Phase 3
Start date August 16, 2018
Completion date August 13, 2026

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