A Phase 3 Multicenter Open-label Study of Brigatinib versus Crizotinib
Research type
Research Study
Full title
A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in Patients with ALK-positive Advanced Lung Cancer
IRAS ID
203281
Contact name
Samreen Ahmed
Contact email
Sponsor organisation
ARIAD Pharmaceuticals, Inc.
Eudract number
2015-003447-19
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The purpose of this phase III, randomized, open-label, comparative, multicenter, international study is to compare the efficacy and safety of brigatinib to that of crizotinib in anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have not previously been treated with an ALK inhibitor. Participants will be randomized in a 1:1 ratio to receive either brigatinib, 90 milligrams (mg) orally once daily (QD) for 7 days, then a 180 mg orally QD, or crizotinib, 250 mg orally twice daily (BID). Participants will receive treatment until disease progression, intolerable toxicity, consent withdrawal, or death. The total estimated duration of the study is at least 5 years, including 2 years to accrue patients, with at least 3 years for treatment and follow-up.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0165
Date of REC Opinion
13 Jun 2016
REC opinion
Further Information Favourable Opinion