Actively Recruiting
Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
Led by University of Nebraska · Updated on 2025-07-24
45
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age = 19 years
- Histologically or cytologically confirmed non-small cell lung cancer with PD-L1 of at least 1%
- Metastatic disease or disease not suitable for curative treatment
- No prior treatment for metastatic NSCLC; early-stage treatment allowed if completed at least 6 months ago and did not include immunotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Measurable disease according to RECIST criteria
- Adequate organ and marrow function, including neutrophil count 1,500/mm3, platelets 100,000/mm3, hemoglobin >9.0 mg/dL, creatinine clearance >60 ml/min/1.73 m2
- Total serum bilirubin <1.5 times upper limit of normal unless Gilbert's syndrome; then bilirubin <2.5 times upper limit
- AST and ALT less than or equal to 2.5 times upper limit of normal, or 5 times if liver metastases present
- For females able to have children, negative pregnancy test within 7 days before treatment and agreement to use effective contraception during treatment and 90 days after
- Male participants must agree to use effective contraception during the trial and for 90 days after
- Able to give informed consent
You will not qualify if you...
- Received any systemic treatments including investigational drugs within the last 28 days
- Known allergy to any components of OT-101 or Pembrolizumab
- Received radiotherapy within 14 days before study intervention (except allowed palliative radiation with 1-week washout)
- Pregnant or breastfeeding women
- History of autoimmune diseases needing systemic treatment in past 2 years (except certain allowed hormone treatments)
- Uncontrolled systemic diseases that may interfere with study
- Active second cancer requiring treatment (exceptions for some skin, bladder, cervical, and prostate cancers)
- Immunodeficiency or on chronic steroids above prednisone 10 mg daily
- Symptomatic brain metastases (asymptomatic or treated brain metastases off steroids allowed)
- Psychiatric or substance use issues interfering with study
- Unable to cooperate with study requirements
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Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
S
Samuel P Anderson, BS
CONTACT
T
Taylor A Johnson, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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