drugset / Trial / NCT05718297

Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer

NCT05718297

RandomizedParallel-groupOpen-labelTreatment

Summary

BOUNCE is an international multicentre randomised phase II trial. The trial treatment consists of brigatinib 180 mg once daily p.o., with seven day lead-in at 90 mg once daily, for 3 years or until progression of disease. The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation, compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement who completed definitive chemo-radiotherapy without disease progression.

Timeline

Start
2024-06-07
Primary completion
2024-09-30
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Brigatinib Small molecule 180 mg Oral
Comparator Durvalumab Monoclonal antibody