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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: Recruiting Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by Emory University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

PFS will be defined as the time from the date of first protocol therapy to the date of first documentation of disease progression or death due to any cause, whichever occurs first. PFS will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. PFS will be calculated with a 95% confidence interval using Kaplan-Meier method based on the efficacy evaluable population.

Conditions Studied

Stage IV Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Advanced Lung Adenocarcinoma Refractory Lung Adenocarcinoma

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

FieldValue
Enrollment Target 50 participants
Start Date 2024-07-31
Est. Completion 2028-09-17
Phase Phase 2
Emory University

1,208 total trials

What NCT06495125 shows while recruiting

NCT06495125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (49% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Stage IV Lung Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06495125's enrollment target sits among peer trials

50 36th of 81 higher than 45 of 81 other Stage IV Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06495125

Source: ClinicalTrials.gov NCT06495125, the US trial registry maintained by the National Library of Medicine. NCT06495125 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.