OncoMatch/Clinical Trials/NCT06579196
Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
Is NCT06579196 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Trabedersen and Pembrolizumab for non-small cell lung cancer.
Treatment: Trabedersen · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) overexpression (PD-L1 of at least 1%)
NSCLC with a PD-L1 of at least 1%
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Exception: Early-stage disease therapy acceptable if completed at least six months prior and did not include immunotherapy.
No prior treatment for metastatic NSCLC. Early-stage disease therapy acceptable if completed at least six months prior and did not include immunotherapy.
Cannot have received: systemic therapy
Received any systemic treatments including investigational agents within the last 28 days
Cannot have received: radiation therapy
Exception: Palliative radiation is allowed during the study with a 1-week washout
Received radiotherapy within 14 days of the study intervention. Palliative radiation is allowed during the study with a 1-week washout
Lab requirements
Blood counts
Absolute neutrophil count ≥1,500/mm3; Platelets ≥100,000/mm3; Hemoglobin >9.0 mg/dL
Kidney function
Creatinine clearance > 60 ml/min/1.73 m2 using CKD-EPI formula
Liver function
Total serum bilirubin <1.5 X ULN except if known to have Gilbert's syndrome, then excluded if total bilirubin >2.5 X ULN; AST/SGOT and ALT/SGPT ≤ 2.5 x ULN; if participant has liver metastases, ≤5x ULN
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 CKD-EPI formula * Total serum bilirubin <1.5 X ULN except if known to have Gilbert's syndrome, then excluded if total bilirubin >2.5 X ULN * AST/SGOT and ALT/SGPT ≤ 2.5 x ULN; if participant has liver metastases, ≤5x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Nebraska Medical Center · Omaha, Nebraska
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