Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1 (NCT06579196)
Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Nebraska Medical Center — Omaha, Nebraska
Age range: 19 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Nebraska Medical Center — Omaha, Nebraska
📞 Contact the Study Coordinator
Phone: (402) 559-1250
Email: samuanderson@unmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer — Houston, Texas
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.