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Phase 1: Dose Escalation for Pembrolizumab and Difluoromethylornithine (DFMO) for Lung Cancer

Phase 1 & 2
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.
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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
I am willing to provide a new tissue sample from my tumor for the study.
My lung cancer is at stage IV.
My cancer has an STK11 mutation.
I am 18 years old or older.
I am fully active or restricted in physically strenuous activity but can do light work.
I am using two birth control methods or am not having sex to avoid pregnancy during and 120 days after the study.


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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2
Completed Phase 1

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,447 Total Patients Enrolled
Jhanelle E. Gray, M.D.Principal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
68 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants enrolled in this clinical study?

"Indeed, the data available on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible participants. The study was initially posted on January 12th, 2024 and most recently updated on the same day. Currently, there are openings for a total of 45 individuals at one designated site."

Answered by AI

Is the recruitment phase of this clinical trial still ongoing?

"Indeed, according to the information provided on clinicaltrials.gov, this investigation is currently in the recruitment phase. The trial was initially made available on January 12th, 2024 and received its most recent update on the same date."

Answered by AI
~30 spots leftby Dec 2028