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Kinase Inhibitor

Defactinib + Avutometinib + Nivolumab for Lung Cancer

Phase 2

Recruiting

Led By Conor E Steuer

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have known LKB1 mutation

Patients must have been histologically or cytologically diagnosed with non-small cell lung cancer, specifically lung adenocarcinoma

Must not have

Patients who experienced serious auto-immune toxicity with prior immune checkpoint inhibitor therapy

History of rhabdomyolysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at start of treatment to death up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of three drugs (defactinib, avutometinib, and nivolumab) to treat patients with advanced non-small cell lung cancer that has not

Who is the study for?

This trial is for patients with advanced non-small cell lung cancer that has LKB1 mutation and hasn't responded to anti-PD1 treatments. It's aimed at those whose cancer may have spread, and who are looking for new treatment options.

What is being tested?

The trial tests a combination of defactinib and avutometinib (kinase inhibitors) with nivolumab (an immunotherapy drug). The goal is to see if this mix can better kill tumor cells in patients resistant to previous anti-PD1 therapy.

What are the potential side effects?

Potential side effects include reactions related to the immune system, such as inflammation in various organs, fatigue, skin issues, digestive problems, and possibly an increased risk of infections due to immune response alteration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has a known LKB1 mutation.

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My lung cancer is specifically diagnosed as adenocarcinoma.

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My liver function tests are within the required range.

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My kidney function is normal or only mildly reduced.

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My heart's electrical activity is within a healthy range, and I don't have a specific heart block condition.

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My advanced disease cannot be treated with surgery or combined therapy.

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I am 18 years old or older.

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I am fully active or have some restrictions but can still care for myself.

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I can take pills by mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a severe allergic reaction to previous immunotherapy.

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I have had rhabdomyolysis in the past.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I do not have an autoimmune condition that worsens with nivolumab.

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I have an active hepatitis B, C, or HIV infection that needs treatment.

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I cannot take pills by mouth or have issues absorbing them due to stomach surgery or active bowel inflammation.

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I am switching from warfarin to another blood thinner due to my treatment.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at start of treatment to death up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at start of treatment to death up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at start of treatment to death up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Duration of response (DOR)

Incidence of adverse events (AEs)

Overall survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (defactinib, avutometinib, nivolumab)Experimental Treatment7 Interventions

Patients receive defactinib PO 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 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, CT or PET on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Defactinib

2013

Completed Phase 1

~60

Positron Emission Tomography

2011

Completed Phase 2

~2200