Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04227028
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-01-10
Brief Title:
Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced Metastatic or Recurrent NSCLC
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase Ib Study of Brigatinib Plus Bevacizumab in Patients With ALK-Rearranged Non-Small Cell Lung Cancer NSCLC Who Have Previously Progressed on Prior ALK-Directed Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 phase Ib trial studies the side effects and best dose of brigatinib and how well it works with bevacizumab in treating patients with ALK-rearranged non-small cell lung cancer that has spread to nearby tissues or lymph nodes locally advanced or other places in the body metastatic or has come back recurrent Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as bevacizumab may interfere with the ability of tumor cells to grow and spread It is not yet known if brigatinib and bevacizumab will work better in treating patients with ALK-rearranged non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine toxicity and tolerability and the maximum tolerated dose MTD of brigatinib and bevacizumab in patients with ALK rearranged non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To describe the dose-limiting toxicities of brigatinib in combination with bevacizumab
II To estimate overall response rate ORR to treatment with brigatinib and bevacizumab
III To estimate the duration of response as defined by the time of first documented clinical benefit to the time of progression
IV To estimate patient survival by measuring progression free survival PFS as defined by the time from treatment initiation to documented disease progression or death from any cause Overall survival OS as defined by the time from treatment initiation until death due to any cause
EXPLORATORY OBJECTIVES
I To identify predictive biomarkers using genetics and tumor immunology-based assessment platforms
Ia Analysis with next-generation sequencing NGS to identify predictive biomarkers for response using tissue and cerebral spinal fluid CSF optional for patients with brain metastases
Ib Tumor tissue will be obtained at baseline and cell free deoxyribonucleic acid DNA cfDNAcell tumor DNA ctDNA obtained at baseline and the time of progression or study completion will be evaluated for genomic alterations and biomarkers
II Evaluation of central nervous system CNS penetration through cerebral spinal fluid CSF obtained by lumbar puncture on cycle 2 day 1 C2D1 with time matched pharmacokinetic PK blood draw and at progression or study completion for consenting patients optional
OUTLINE This is a dose-escalation study of brigatinib
Patients receive brigatinib orally PO once daily QD on days 1-28 of cycle 1 and days 1-21 of subsequent cycles Patients also receive bevacizumab intravenously IV on day 8 of cycle 1 and day 1 of subsequent cycles Starting cycle 2 cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days 3 6 9 and 12 months then every 6 months for up to 3 years
I To determine toxicity and tolerability and the maximum tolerated dose MTD of brigatinib and bevacizumab in patients with ALK rearranged non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To describe the dose-limiting toxicities of brigatinib in combination with bevacizumab
II To estimate overall response rate ORR to treatment with brigatinib and bevacizumab
III To estimate the duration of response as defined by the time of first documented clinical benefit to the time of progression
IV To estimate patient survival by measuring progression free survival PFS as defined by the time from treatment initiation to documented disease progression or death from any cause Overall survival OS as defined by the time from treatment initiation until death due to any cause
EXPLORATORY OBJECTIVES
I To identify predictive biomarkers using genetics and tumor immunology-based assessment platforms
Ia Analysis with next-generation sequencing NGS to identify predictive biomarkers for response using tissue and cerebral spinal fluid CSF optional for patients with brain metastases
Ib Tumor tissue will be obtained at baseline and cell free deoxyribonucleic acid DNA cfDNAcell tumor DNA ctDNA obtained at baseline and the time of progression or study completion will be evaluated for genomic alterations and biomarkers
II Evaluation of central nervous system CNS penetration through cerebral spinal fluid CSF obtained by lumbar puncture on cycle 2 day 1 C2D1 with time matched pharmacokinetic PK blood draw and at progression or study completion for consenting patients optional
OUTLINE This is a dose-escalation study of brigatinib
Patients receive brigatinib orally PO once daily QD on days 1-28 of cycle 1 and days 1-21 of subsequent cycles Patients also receive bevacizumab intravenously IV on day 8 of cycle 1 and day 1 of subsequent cycles Starting cycle 2 cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days 3 6 9 and 12 months then every 6 months for up to 3 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-08726 | REGISTRY | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP30CA060553 |
| STU00211030 | None | None | None |
| NU 19L01 | OTHER | None | None |
| P30CA060553 | NIH | None | None |