Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05735327
Status:
RECRUITING
Last Update Posted:
2023-09-05
First Post:
2023-02-10
Brief Title:
A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer NSCLC ENTIRETY
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Effectiveness and Safety of Brigatinib Treatment as First-line Therapy Administered to ALK Positive Non-Small Cell Lung Cancer NSCLC Patients Prospective Multicenter Observational Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ENTIRETY
Brief Summary:
This is a study of brigatinib in adults with Non-Small Cell Lung Cancer NSCLC The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib Another aim is to learn about the overall rate of participants who respond to the treatment with brigatinib
Participants will receive brigatinib as part of their normal clinical practice Data will be collected during regular visits to the hospital a total of up to 12 visits is planned throughout study duration
Participants will receive brigatinib as part of their normal clinical practice Data will be collected during regular visits to the hospital a total of up to 12 visits is planned throughout study duration
Detailed Description:
This is a non-interventional prospective study of Polish participants with ALK positive NSCLC receiving Brigatinib as their first line of treatment in the scope of routine clinical practice within the frames of National Drug Program NDP This study will evaluate progression-free survival from the time of the first dose of brigatinib
This study will enrol approximately 50 participants Participants will be enrolled in the following cohort to be observed at baseline and every 3 months up to 33 months
Brigatinib
This multi-center trial will be conducted in Poland The overall duration of the study will include approximately 18 months of enrolment and approximately 33 months of data collection and follow-up
This study will enrol approximately 50 participants Participants will be enrolled in the following cohort to be observed at baseline and every 3 months up to 33 months
Brigatinib
This multi-center trial will be conducted in Poland The overall duration of the study will include approximately 18 months of enrolment and approximately 33 months of data collection and follow-up
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