Last updated on June 2019

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


Brief description of study

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 Study Identifier: NCT03456076

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MGH Cancer Center

Boston, MA United States
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University of Michigan

Ann Arbor, MI United States
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Allegheny General Hospital

Pittsburgh, PA United States
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Uni Hospital Mostar

Mostar, Bosnia and Herzegovina
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CHU Angers

Angers, France
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Private Health Organization Acibadem Sistina Hospital

Skopje, Macedonia, The Former Yugoslav Republic of
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Townsville Hospital

Townsville, Australia
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National Cancer Center

Gyeonggi-do, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Recruitment Status: Open


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