NCT04223596

Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients

Clinical Utility of Liquid Biopsy as a Tool to Assess the Evolution of Brigatinib Treated Patients With Non-small Cell Lung Cancer With EML4-ALK Translocation: an Exploratory Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Fundación GECP · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• NSCLC
• NSCLC Stage IIIB
• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	Brigatinib	Brigatinib 90 mg for the first 7 days (D1-7 at cycle 1) and then 180 mg daily thereafter for QW4 cycles of duration (28 days+-3 days)

Timeline

• Start date: 2020-05-04
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2020-01-10
• Last updated: 2026-02-04

Locations

15 sites across 1 country: Spain