Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05200481
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2022-01-07
Brief Title:
Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer MASTERPROTOCOL ALK
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Organization:
Intergroupe Francophone de Cancerologie Thoracique
Study Overview
Official Title:
A Phase II Randomized Open-Labelled Multicenter Study of Safety Efficacy of Combination Brigatinib and Carboplatin-Pemetrexed Therapy or Brigatinib Monotherapy As First-Line Treatment in Advanced ALK-Positive Non-Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II randomized open-labelled non-comparative multicenter study in which ALK NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy Arm A or brigatinib and carboplatin-pemetrexed therapy Arm B An estimated 110 patients 55 in Arm A 55 in Arm B will be enrolled at approximately 30 centers A safety phase will evaluate the safety of brigatinib with carboplatin and pemetrexed treatment combination Arm B The first twenty-six patients enrolled in Arm B will represent the population of the safety phase Patients will be treated until they experience progressive disease intolerable toxicity or another discontinuation criterion is met Continuation of brigatinib beyond progression is permitted at the investigators discretion if there is evidence of continued clinical benefit The null hypothesis is progression free survival at 12 months 69 for Arm B which is considered not sufficiently clinically meaningful to warrant further study The alternative hypothesis is that 86 or more of patients in Arm B would achieve progression free survival at 12 months
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