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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 1 of 5 entries · Site details revised · 2 more Show 5 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised
    • Publications: details revised at 30 of 31 entries
    • Study description expanded, about 5 words
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2025 to May 12, 2025 · Site details revisedv8 Show 2 more changesShow less
    • Start date changed from estimate of May 2025 to May 12, 2025
    • Site details revised
  3. Start date: Mar 2025 to May 2025v7
  4. Eligibility criteria shortened, about 11 wordsv6 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Jan 2028 to Mar 2028 Completion date: Dec 2029 to Feb 2029 · Start date: Jan 2025 to Mar 2025v4 Show 2 more changesShow less
    • Completion date: Dec 2029 to Feb 2029
    • Start date: Jan 2025 to Mar 2025
  2. Eligibility criteria shortened, about 62 wordsv3 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06579196
Lead Sponsor University of Nebraska
Conditions Non-small Cell Lung Cancer
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov