Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522360
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer BrightStar-2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer BrightStar-2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy such as radiotherapy or surgery or chemotherapy pemetrexed and carboplatin can help to control the disease compared with brigatinib alone The safety of these combinations will also be studied
Detailed Description:
To compare the 2-year PFS rate of ALK NSCLC patients treated with brigatinib to those treated with brigatinib and local consolidation therapy LCT
To compare the 2-year PFS rate of ALK NSCLC patients treated with brigatinib to those treated with brigatinib and chemotherapy
To assess the safety and tolerability of brigatinib and LCT To assess the safety and tolerability of brigatinib and chemotherapy
To increase trial enrollment in underserved population
To determine overall survival OS in patients treated with single agent brigatinib brigatinib plus LCT and brigatinib plus chemotherapy
To assess the time to progression of non-LCT lesions in the brigatinib plus LCT arm
To compare the 2-year PFS rate of ALK NSCLC patients treated with brigatinib to those treated with brigatinib and chemotherapy
To assess the safety and tolerability of brigatinib and LCT To assess the safety and tolerability of brigatinib and chemotherapy
To increase trial enrollment in underserved population
To determine overall survival OS in patients treated with single agent brigatinib brigatinib plus LCT and brigatinib plus chemotherapy
To assess the time to progression of non-LCT lesions in the brigatinib plus LCT arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None