Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03707938
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2018-10-12
Brief Title:
Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
BRIGHTSTAR A Pilot Trial of Local Consolidative Therapy LCT With Brigatinib in Tyrosine Kinase Inhibitor-Naive ALK-Rearranged Advanced NSCLC
Status:
ACTIVE_NOT_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:
This early phase I trial studies the side effects and how well local consolidative therapy LCT and brigatinib works in treating patients with non-small cell lung cancer that is stage IV or has come back recurrent Giving LCT such as surgery andor radiation after initial treatment may kill any remaining tumor cells Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving LCT and brigatinib may work better in treating patients with non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety tolerability and feasibility of brigatinib with local consolidative therapy LCT in tyrosine kinase inhibitor-naive ALK-rearranged advanced non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To determine progression-free survival PFS using modified Response Evaluation Criteria in Solid Tumors RECIST 11 in advanced ALK NSCLC patients treated with local consolidative therapy LCT after achieving stable disease or partial response with first-line brigatinib treatment
II To determine overall survival OS
III To assess time to progression TTP of non-LCT lesions
EXPLORATORY OBJECTIVES
I To assess time to appearance of new metastatic lesions
II To determine the utility of pre-treatment pre-LCT and post-LCT circulating free tumor deoxyribonucleic acid DNA cfDNA as a potential prognostic and predictive biomarkers
II To evaluate potential impact of LCT on mechanisms of ALK resistance with molecular analysis of post-progression biopsies
OUTLINE
Patients receive brigatinib orally PO once daily QD on days 1-28 Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients then undergo LCT for up to 3 weeks in the absence of disease progression or unacceptable toxicity Within 7 days after completion of LCT patients receive brigatinib PO QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and every 3 months for up to 2 years
I To assess the safety tolerability and feasibility of brigatinib with local consolidative therapy LCT in tyrosine kinase inhibitor-naive ALK-rearranged advanced non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To determine progression-free survival PFS using modified Response Evaluation Criteria in Solid Tumors RECIST 11 in advanced ALK NSCLC patients treated with local consolidative therapy LCT after achieving stable disease or partial response with first-line brigatinib treatment
II To determine overall survival OS
III To assess time to progression TTP of non-LCT lesions
EXPLORATORY OBJECTIVES
I To assess time to appearance of new metastatic lesions
II To determine the utility of pre-treatment pre-LCT and post-LCT circulating free tumor deoxyribonucleic acid DNA cfDNA as a potential prognostic and predictive biomarkers
II To evaluate potential impact of LCT on mechanisms of ALK resistance with molecular analysis of post-progression biopsies
OUTLINE
Patients receive brigatinib orally PO once daily QD on days 1-28 Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients then undergo LCT for up to 3 weeks in the absence of disease progression or unacceptable toxicity Within 7 days after completion of LCT patients receive brigatinib PO QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and every 3 months for up to 2 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2018-02099 | REGISTRY | None | None |
| 2018-0598 | OTHER | M D Anderson Cancer Center | None |