Status:
RECRUITING
Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
Lead Sponsor:
University of Nebraska
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief 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 ther...
Detailed Description
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 ther...
Eligibility Criteria
Inclusion
- 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
- Platelets ≥100,000/mm3
- Hemoglobin \>9.0 mg/dL
- Creatinine clearance \> 60 ml/min/1.73 m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- Total serum bilirubin \<1.5 X upper limit of normal (ULN) except if known to have Gilbert's syndrome, then excluded if total bilirubin \>2.5 X ULN
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 x ULN; if participant has liver metastases, ≤5x ULN
- For females of childbearing potential, negative serum or urine pregnancy test ≤7 days of treatment, \& agree to use effective contraceptive during treatment \& 90 days after end of treatment
- Male participants must agree to use effective contraception during the trial \& for 90 days after end of treatment
- Able to give informed consent
Exclusion
- 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
- Symptomatic brain metastases. Asymptomatic metastases or having received treatment for brain metastases and are off steroid therapy is acceptable.
- Known psychiatric or substance use that would interfere with the study requirements
- Inability to co-operate with the requirements of the protocol
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06579196
Start Date
May 12 2025
End Date
February 1 2029
Last Update
July 24 2025
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198