Trials / Withdrawn
WithdrawnNCT05718297
Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer
A Multicentre, Randomised, Phase II Trial of Brigatinib Consolidation Versus Observation or Durvalumab in Patients with Unresectable Stage III NSCLC and ALK-rearrangement, After Definitive Chemo-radiotherapy
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- ETOP IBCSG Partners Foundation · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brigatinib | Brigatinib is administered for 3 years or until progression of disease, or unacceptable toxicities or withdrawal of consent, whatever occurs first. After the treatment period of 3 years, patient's ongoing treatment will be managed according to local standard and best clinical practice. Brigatinib should be taken approximately at the same time each day. It may be taken with or without food. Patients shall be instructed to swallow the tablets whole and not crush or chew them. |
| DRUG | Durvalumab | Patients in the control arm will be observational, or, as per investigators choice, patients may receive durvalumab, administered within the label in the respective country. |
Timeline
- Start date
- 2024-06-07
- Primary completion
- 2024-09-30
- Completion
- 2024-09-30
- First posted
- 2023-02-08
- Last updated
- 2024-10-08
Locations
20 sites across 5 countries: France, Italy, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05718297. Inclusion in this directory is not an endorsement.