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

Eligibility Criteria

• * 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
• * 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