Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837716
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2021-04-05
Brief Title:
Ensartinib Carboplatin Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase 1b Study of Ensartinib in Combination With Platinum-Based Chemotherapy and Bevacizumab in ALK-Positive Non-Small Cell Lung Cancer NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 phase Ib trial finds the best dose and side effects of ensartinib and its effects when given with carboplatin pemetrexed and bevacizumab for in treating patients with ALK-positive non-small cell lung cancer that is stage IIIC or IV or has come back recurrent Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Chemotherapy drugs such as carboplatin and pemetrexed work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread Giving ensartinib carboplatin pemetrexed and bevacizumab may help to control the disease
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety of ensartinib in combination with carboplatin pemetrexed and bevacizumab in patients with ALK-rearranged advanced non-small cell lung cancer NSCLC
II Determine the recommended phase 2 dose RP2D of ensartinib in combination with carboplatin pemetrexed and bevacizumab
SECONDARY OBJECTIVES
I To determine an objective response rate ORR in patients with ALK-rearranged advanced NSCLC treated with ensartinib in combination with carboplatin pemetrexed and bevacizumab using modified Response Evaluation Criteria in Solid Tumors RECIST 11
II To determine progression-free survival PFS III To determine overall survival
EXPLORATORY OBJECTIVE
I To determine biomarkers associated with response and resistance to the study combination
OUTLINE This is a dose de-escalation study of ensartinib and fixed-dose carboplatin pemetrexed and bevacizumab followed by a dose-expansion study
INDUCTION THERAPY Patients receive ensartinib orally PO once daily QD on days 1-21 carboplatin intravenously IV over 15-60 minutes on day 1 pemetrexed IV over 10 minutes on day 1 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE THERAPY Patients receive ensartinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
I To determine the safety of ensartinib in combination with carboplatin pemetrexed and bevacizumab in patients with ALK-rearranged advanced non-small cell lung cancer NSCLC
II Determine the recommended phase 2 dose RP2D of ensartinib in combination with carboplatin pemetrexed and bevacizumab
SECONDARY OBJECTIVES
I To determine an objective response rate ORR in patients with ALK-rearranged advanced NSCLC treated with ensartinib in combination with carboplatin pemetrexed and bevacizumab using modified Response Evaluation Criteria in Solid Tumors RECIST 11
II To determine progression-free survival PFS III To determine overall survival
EXPLORATORY OBJECTIVE
I To determine biomarkers associated with response and resistance to the study combination
OUTLINE This is a dose de-escalation study of ensartinib and fixed-dose carboplatin pemetrexed and bevacizumab followed by a dose-expansion study
INDUCTION THERAPY Patients receive ensartinib orally PO once daily QD on days 1-21 carboplatin intravenously IV over 15-60 minutes on day 1 pemetrexed IV over 10 minutes on day 1 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE THERAPY Patients receive ensartinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
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-2021-02560 | REGISTRY | None | None |
| 2020-0838 | OTHER | M D Anderson Cancer Center | None |