Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 05 September 2018

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 ALK-positive locally advanced or metastatic NSCLC...

purpose

Brief Summary:
A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in ALK-positive Advanced Lung Cancer Participants.

Detailed Description:
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 ALK-positive locally advanced or metastatic NSCLC participants who have not previously been treated with an ALK inhibitor. Participants will be randomized in a 1:1 ratio to receive either brigatinib, 90 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 participants, with at least 3 years for treatment and follow-up.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer
Actual Study Start Date: May 26, 2016
Estimated Primary Completion Date: July 31, 2020
Estimated Study Completion Date: July 31, 2020

Arm:
- Experimental:
Brigatinib
- Active Comparator: Crizotinib

Category Value
Date last updated at source 23-Aug-18
Study type(s) Interventional
Expected enrolment 275
Study start date 26-May-16
Estimated primary completion date 31-Jul-20

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