Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
Eligible age
19+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Nebraska
You may qualify if…
- ✓ Age ≥ 19 years
- ✓ Histologically/cytologically proven diagnosis of non-small cell lung cancer (NSCLC) with a PD-L1 of at least 1%
- ✓ Metastatic disease or disease not amenable for curative intent therapy
- ✓ No prior treatment for metastatic NSCLC. Early-stage disease therapy acceptable if completed at least six months prior and did not include immunotherapy.
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- ✓ Measurable disease by RECIST criteria
- ✓ Adequate organ and marrow function as defined below:
- ✓ Absolute neutrophil count ≥1,500/mm3
You may not qualify if…
- ✕ Received any systemic treatments including investigational agents within the last 28 days
- ✕ Known hypersensitivity to any of the excipients of OT101 or pembrolizumab
- ✕ Received radiotherapy within 14 days of the study intervention. Palliative radiation is allowed during the study with a 1-week washout
- ✕ Pregnant or breast-feeding women
- ✕ History of autoimmune diseases that required systemic treatment in the past 2 years with agents such as, but not limited to, corticosteroids or immunosuppressive drugs. Thyroid replacement for hypothyroidism, insulin treatment for type I diabetes or corticosteroids adrenal/pituitary insufficiency are allowed.
- ✕ Uncontrolled systemic diseases that in the opinion of the investigator may interfere with the protocol activities
- ✕ Known active second malignancy that needs treatment. Exceptions include basal cell or squamous cancers of the skin, bladder or cervical carcinoma in situ, prostate cancer on hormone therapy alone.
- ✕ Immunodeficiency diagnosis or receiving chronic steroids that exceed a dose equivalent to prednisone 10 mg daily
Where it's recruiting
Omaha
Source: ClinicalTrials.gov · NCT06579196 · last updated 2025-07-24