At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 103 enrolled
Drug / intervention
Brigatinibdrug
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.
Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
In Brief
A Phase 2 clinical trial evaluating Brigatinib for ALK-positive Advanced NSCLC. Completed, enrolled 103 participants across 80 sites in 15 countries.
Detailed Summary
The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors \[RECIST\]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALK-positive Advanced NSCLC
CountriesAustralia, Austria, Canada, China, France, Germany, Hong Kong, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United States
CollaboratorsTakeda
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartJan 2019
Primary CompletionSep 2020
Study CompletionAug 2024
TodayJul 2026
First PostedMay 24, 2018
Enrollment StartJan 31, 2019
Primary CompletionSep 30, 2020
Study CompletionAug 21, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.1 years ago
Interventions
Brigatinibdrug
Brigatinib Tablets