drugset / Trial / NCT05718297
Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brigatinib | Small molecule | 180 mg | Oral |
| Comparator | Durvalumab | Monoclonal antibody | — | — |