Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients

This is an open-label, non-randomised, phase II, exploratory, multi-country and multi-centre clinical trial. Chemotherapy-naïve patients with EML4-ALK rearrangement and with locally advanced or metastatic non-small cell lung cancer patients will be selected. Patients enrolled in the study will receive brigatinib 90mg for the first 7 days (D 1-7 at cycle 1) and then 180mg daily thereafter for QW4 cycles of duration (28 days ±3days). Brigatinib will be administered until progression disease, unacceptable toxicity, patient or physician decision to discontinue or death. Brigatinib may continue beyond disease progression per RECIST v1.1 until loss of clinical benefit, unacceptable toxicity, patient or physician decision to discontinue, or death as per SmPC recommendations. Patient accrual is expected to be completed within 1.5 years excluding a run-in-period of 4-6 months. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 1 year after the end of treatment independently of the cause of end of treatment. The study will end once survival follow-up has concluded. The trial will end with the preparation of the final report, scheduled for 5.5 years after the inclusion of the first patient approximately.

NCT Number	NCT04223596
Lead Sponsor	Fundación GECP
Conditions	Lung Cancer, NSCLC, NSCLC Stage IIIB, NSCLC Stage IV
Enrollment	33 participants
Start Date	2020-05-04
Primary Completion	2026-11-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-04