CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 275 enrolled
Drug / intervention
Brigatinib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically or cytologically confirmed stage IIIB (not a candidate for definitive multimodality therapy) or stage IV NSCLC
  • ✓Documented ALK rearrangement
  • ✓At least 1 measurable lesion per RECIST v1.1
  • ✓ECOG performance status ≤2
Key exclusion· 14
  • ✕Prior tyrosine kinase inhibitor (TKI) therapy, including ALK-targeted TKIs
  • ✕Prior investigational antineoplastic agent for NSCLC
  • ✕More than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease
  • ✕Chemotherapy or radiation within 14 days of first dose (except SRS/SBRT)

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

Search/NCT02737501
NCT02737501Phase 3Completed
CompareCT.gov

A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer

Ariad Pharmaceuticals·interventional·Posted Apr 14, 2016·Updated Aug 20, 2021

In Brief

A Phase 3 clinical trial evaluating Brigatinib and Crizotinib for Non-small Cell Lung Cancer and 3 related conditions. Completed, enrolled 275 participants across 91 sites in 19 countries.

Detailed Summary

The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer, Lung Cancer, Advanced Malignancies, Carcinoma
CountriesAustralia, Austria, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Netherlands, Norway, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 14, 2016
Enrollment StartMay 26, 2016
Primary CompletionJul 28, 2020
Study CompletionJan 29, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.2 years ago

Interventions

Brigatinibdrug

Brigatinib tablets

Crizotinibdrug

Crizotinib tablets