Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495125
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Defactinib Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Phase 2 Study of Defactinib and Avutometinib in Combination With Nivolumab for Patients With Anti-PD1 Refractory LKB1-Mutant Advanced Lung Adenocarcinoma
Status:
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 II trial tests how well defactinib and avutometinib in combination with nivolumab works in treating patients with LKB1-mutant non-small cell lung cancer that has not responded refractory to an anti-PD1 treatment and may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced Defactinib and avutometinib belong to a class of drugs called kinase inhibitors These drugs target kinase proteins found in tumor cells Tumor cells need these proteins to survive and grow By blocking these proteins defactinib and avutometinib may cause tumors to stop growing or grow more slowly Immunotherapy with monoclonal antibodies such as nivolumab may help the bodys immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread Giving defactinib and avutometinib in combination with nivolumab may kill more tumor cells in patients with anti-PD1 refractory LKB1-mutant advanced non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine the efficacy 6-months progression free survival PFS rate of defactinib and avutometinib when combined with nivolumab in patients with LKB1 mutated lung adenocarcinoma
SECONDARY OBJECTIVE
I To evaluate response rate overall survival and toxicity assessment
TERTIARYEXPLORATORY OBJECTIVE
I Biomarker evaluation will be conducted on archived tumor samples and on-study biopsies obtained in a subset of patients
OUTLINE
Patients receive defactinib orally PO twice daily BID on days 1-21 avutometinib PO twice weekly on Monday and Thursday Tuesday and Friday or Wednesday and Saturday for 21 days and nivolumab intravenously IV on day 1 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo biopsy blood sample collection computed tomography CT or positron emission tomography PET on study
After completion of study treatment patients are followed up every 3 months for up to 5 years
I To determine the efficacy 6-months progression free survival PFS rate of defactinib and avutometinib when combined with nivolumab in patients with LKB1 mutated lung adenocarcinoma
SECONDARY OBJECTIVE
I To evaluate response rate overall survival and toxicity assessment
TERTIARYEXPLORATORY OBJECTIVE
I Biomarker evaluation will be conducted on archived tumor samples and on-study biopsies obtained in a subset of patients
OUTLINE
Patients receive defactinib orally PO twice daily BID on days 1-21 avutometinib PO twice weekly on Monday and Thursday Tuesday and Friday or Wednesday and Saturday for 21 days and nivolumab intravenously IV on day 1 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo biopsy blood sample collection computed tomography CT or positron emission tomography PET on study
After completion of study treatment patients are followed up every 3 months for up to 5 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-2024-04302 | REGISTRY | None | None |
| STUDY00006144 | None | None | None |
| WINSHIP5947-23 | OTHER | None | None |
| P01CA257906 | NIH | None | None |
| P30CA138292 | NIH | None | None |