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

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

Outcome

Outcome not reported

Stopped (Enrollment): “Despite our efforts, the trial faced challenges like a longer activation period and slower accrual. We proposed a redesign, but TAKEDA withdrew. As a non-profit organisation, we can't continue without TAKEDA's support and must discontinue the trial.”

Drugs

Indications