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NCT06495125 · ClinicalTrials.gov registry record · Phase 2
Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT06495125 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 50 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (49% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT06495125, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Avutometinib
- DRUG Defactinib
Study Locations (3)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2028-09-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06495125
The ClinicalTrials.gov registry entry for NCT06495125 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (49% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06495125 reports 3 study locations spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT06495125 about?
NCT06495125 is a clinical study titled "Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer". 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 nod...
What is the current status of trial NCT06495125?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-07-31. Estimated completion is 2028-09-17.
What conditions does trial NCT06495125 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Advanced Lung Adenocarcinoma, Refractory Lung Adenocarcinoma.
What interventions are being tested in trial NCT06495125?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Avutometinib (DRUG), Defactinib (DRUG).
Who is sponsoring clinical trial NCT06495125?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06495125 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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