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DFMO + Pembrolizumab for Lung Cancer

Phase 1 & 2

Recruiting

Led By Jhanelle E. Gray, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Patients enrolled on the Phase II trial must be willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.

Patients must have a histologic or cytologic diagnosis of Stage IV NSCLC.

Must not have

Patients that have an active infection requiring systemic therapy.

Patients that have a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses ≥ 10 mg prednisone or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial aims to test the safety and effectiveness of a drug called Difluoromethylornithine (DFMO) when used in combination with pembrolizumab for the treatment of

Who is the study for?

This trial is for adults with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Participants should not have had prior treatment with DFMO or pembrolizumab. They must be able to perform daily activities with minimal assistance and have acceptable organ function.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of combining Difluoromethylornithine (DFMO), a drug that targets cancer cell growth, with pembrolizumab, an immunotherapy drug. The goal is to see if this combination works better for treating NSCLC than current options.See study design

What are the potential side effects?

Possible side effects include immune-related reactions such as skin rash, colitis, hepatitis, endocrine disorders like thyroid dysfunction; fatigue; nausea; and potential blood abnormalities. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

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

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I am willing to provide a new tissue sample from my tumor for the study.

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My lung cancer is at stage IV.

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My cancer has an STK11 mutation.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am using two birth control methods or am not having sex to avoid pregnancy during and 120 days after the study.

Exclusion Criteria

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

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I am currently being treated for an infection.

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.

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I have been diagnosed with HIV.

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I have or had lung inflammation not caused by infection, treated with steroids.

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My cancer does not have STK11 variants considered non-harmful.

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I have active Hepatitis B or C.

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I haven't been in a drug or device trial within the last 4 weeks.

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I have cancer that has spread to my brain or spinal cord.

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I have interstitial lung disease.

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I have a history of heart failure that affects my daily activities.

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I have a history of tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I- Maximum Tolerated Dose (MTD)

Phase II- Objective Response Rate (ORR)

Secondary outcome measures

Phase II- Overall Survival (OS)

Phase II- Progression Free Survival (PFS)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Phase 1: Dose Escalation for Pembrolizumab and Difluoromethylornithine (DFMO)Experimental Treatment2 Interventions

Difluoromethylornithine (DFMO) + Pembrolizumab Pre-treated or treatment naive advanced or metastatic NSCLC. The phase I dose escalation will include a fixed dose of Pembrolizumab IV every 3 weeks and escalating doses of DFMO (three dose levels) to determine the maximum tolerated dose (MTD) to be used in the phase II portion of the trial. DFMO level -1: Dose Level -1: 4500 mg/m2 by mouth (PO) once a day (QD). DFMO Level 1: (start): 6750 mg/m2 PO QD Dose Level 2: 9000 mg/m2 PO QD

Group II: Phase II: Pembrolizumab and Difluoromethylornithine (DFMO)Active Control2 Interventions

Difluoromethylornithine (DFMO) + Pembrolizumab Advanced/metastatic NSCLC who are immunotherapy naïve. Pembrolizumab IV flat dose every 3 weeks DFMO dose to be determined (TBD) based on maximum tolerated dose (MTD) and dose limiting toxicities (DLT) in Phase I dose escalation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Difluoromethylornithine

2015

Completed Phase 1

~50

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

549 Previous Clinical Trials

135,665 Total Patients Enrolled

Jhanelle E. Gray, M.D.Principal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

68 Total Patients Enrolled

~30 spots leftby Dec 2028

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