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NCT06579196 · ClinicalTrials.gov registry record · Phase 1
Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT06579196 is a Phase 1 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 45 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06579196, a Phase 1 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trabedersen
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-05-12 |
| Est. Completion | 2029-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06579196
The ClinicalTrials.gov registry entry for NCT06579196 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06579196 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT06579196 about?
NCT06579196 is a clinical study titled "Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1". 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 answ...
What is the current status of trial NCT06579196?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2025-05-12. Estimated completion is 2029-02.
What conditions does trial NCT06579196 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06579196?
The interventions under investigation include: Pembrolizumab (DRUG), Trabedersen (DRUG).
Who is sponsoring clinical trial NCT06579196?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06579196 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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