CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 248 enrolled
Drug / intervention
Brigatinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03596866
NCT03596866Phase 3Completed

A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)

Takeda·interventional·Posted Jul 24, 2018·Updated Sep 12, 2025

In Brief

A Phase 3 clinical trial evaluating Brigatinib and Alectinib for ALK+ Advanced NSCLC. Completed, enrolled 248 participants across 114 sites in 20 countries.

Detailed Summary

Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: * Brigatinib tablets * Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 24, 2018
Enrollment StartApr 19, 2019
Primary CompletionFeb 27, 2024
Study CompletionSep 18, 2024
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.9 years ago

Interventions

Brigatinibdrug

Brigatinib Tablets.

Alectinibdrug

Alectinib Capsules.