Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-03 @ 11:20 PM
Study NCT ID:
NCT06522360
Status:
WITHDRAWN
Last Update Posted:
2025-04-24
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)
Status:
WITHDRAWN
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
0 participants enrolled
Has Expanded Access:
False
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:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-06173 | OTHER | NCI-CTRP Clinical Trials Registry | View |