NCT06219174

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

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

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Non Small Cell Lung Cancer
• Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-07
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2024-01-23
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study