drugset / Trial / NCT06219174

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

NCT06219174

Phase 1/2 Suspended 45 enrolled H. Lee Moffitt Cancer Center and Research Institute
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2024-08-07
Primary completion
2029-08
Completion
2029-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Eflornithine Small molecule 4500 mg/m2 Oral
Subject Eflornithine Small molecule 6750 mg/m2 Oral
Subject Eflornithine Small molecule 9000 mg/m2 Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous