Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
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
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |