Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients
Status:
Recruiting
Trial end date:
2025-04-15
Target enrollment:
Participant gender:
Summary
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.