RecruitingPhase 2NCT06495125

Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer

A Phase 2 Study of Defactinib and Avutometinib, in Combination With Nivolumab for Patients With Anti-PD1 Refractory LKB1-Mutant Advanced Lung Adenocarcinoma


Sponsor

Emory University

Enrollment

50 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

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 body's 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a triple-drug combination — defactinib, avutometinib, and nivolumab — for people with advanced lung adenocarcinoma (a type of non-small cell lung cancer) that has a specific genetic mutation in LKB1 and has stopped responding to immunotherapy. **You may be eligible if...** - You have been diagnosed with advanced lung adenocarcinoma that cannot be surgically removed - Your tumor has been tested and has a known LKB1 mutation - Your cancer has progressed after prior immunotherapy and first-line chemotherapy - You are in reasonably good physical condition **You may NOT be eligible if...** - You have received more than one prior line of chemotherapy for advanced disease - You have active brain metastases that are untreated or unstable - You have serious autoimmune disease or active infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAvutometinib

Given PO

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

DRUGDefactinib

Given PO

BIOLOGICALNivolumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET


Locations(3)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT06495125


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