drugset / Trial / NCT06579196

Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1

NCT06579196

Phase 1/2 Recruiting 45 enrolled University of Nebraska
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to: 1) evaluate the safety and recommended dose of the drug OT-101/Trabedersen when combined with Pembrolizumab and 2) determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer. The main question(s) it aims to answer are: * What medical problems to participants have when taking OT101 together with Pembrolizumab? * What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy? * Does the combination therapy delay progression or relapse of the participant\'s Non-Small Cell Lung Cancer? Participants will: * Receive intravenous OT-101/Trabedersen for 4 days once every 2 weeks. Clinic visits are required to receive and disconnect the infusion. * Receive intravenous Pembrolizumab once every 6 weeks.

Timeline

Start
2025-05-12
Primary completion
2028-03
Completion
2029-02

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject trabedersen Antisense oligonucleotide 140 mg/m2 Intravenous
Subject trabedersen Antisense oligonucleotide 190 mg/m2 Intravenous
Subject trabedersen Antisense oligonucleotide 250 mg/m2 Intravenous
Background Pembrolizumab Monoclonal antibody 400 mg Intravenous