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Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC (DFMO)

NCT06219174 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-06

No results posted yet for this study

Summary

The purpose of this study is to establish the safety, toxicity, and tolerability of Difluoromethylornithine (DFMO) in combination with pembrolizumab in advanced/metastatic Non-Small Cell Lung Cancer (NSCLC). Researchers also want to investigate how effective DFMO is at treating patients with advanced/ metastatic NSCLC.

Conditions

Interventions

DRUG

Pembrolizumab

200 mg IV Q3 weeks

DRUG

Difluoromethylornithine

Dose Level -1: 4500 mg/m2 by mouth (PO) daily Dose Level 1: 6750 mg/m2 by mouth (PO) daily Dose Level 2: 9000 mg/m2 by mouth (PO) daily

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jhanelle E. Gray, M.D. · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2029-08-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219174 on ClinicalTrials.gov