Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05718297
Status:
WITHDRAWN
Last Update Posted:
2024-07-12
First Post:
2023-01-30
Brief Title:
Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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 cant continue without TAKEDAs support and must discontinue the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOUNCE
Brief Summary:
BOUNCE is an international multicentre randomised phase II trial The trial treatment consists of brigatinib 180 mg once daily po 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 observationdurvalumab in patients with unresectable stage III NSCLC and ALK-rearrangement who completed definitive chemo-radiotherapy without disease progression
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None