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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: Recruiting Phase 1 study of Non-Small Cell Lung Cancer, sponsored by University of Nebraska.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose Limiting toxicity (DLT) and Maximum Tolerated Dose (MTD)
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 |
What NCT06579196 shows while recruiting
NCT06579196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06579196's enrollment target sits among peer trials
45 344th of 454 higher than 111 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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