Trabedersen (OT-101) with Pembrolizumab for the Treatment of Newly Diagnosed PD-L1 Positive Metastatic Non-small Cell Lung Cancer

Inclusion Criteria

• Age ≥ 19 years
• A 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
• Patients did not receive any prior treatment for metastatic NSCLC. Patients who received systemic therapy for early-stage disease are eligible as long as it has been at least 6 months, since completion of such therapy and they did not receive immunotherapy treatment in earlier stages
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelets ≥ 100,000/mm^3
• Hemoglobin > 9.0 mg/dL
• Creatinine clearance > 50 ml/min/1.73 m^2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
• Total serum bilirubin < 1.5 x upper limit of normal (ULN) except if patient is known to have Gilbert’s syndrome then they will be excluded if total bilirubin is > 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, ≤ 5 x ULN
• Serum or urine pregnancy test (for females of childbearing potential) negative ≤ 7 days of treatment
• Male participants must agree to use effective contraception during the trial period and for 4 months after completion of treatment
• Female participants must not be pregnant or breast feeding. If she is at childbearing potential, she must agree to use effective contraceptive during the treatment period and 4 months after completion of treatment
• Able to give informed consent

Exclusion Criteria

• Has an EGFR sensitizing mutation and/or ALK translocation
• Has received any systemic treatments for metastatic disease including investigational agents within the last 28 days
• Known hypersensitivity to any of the excipients of OT101 or pembrolizumab
• Has received radiotherapy within 14 days of the study intervention. However, palliative radiation is allowed during the study with a 1-week washout
• Pregnant or breast-feeding women
• History of autoimmune diseases that has required systemic treatment in the past 2 years with agents such as but not limited to corticosteroids or immunosuppressive drugs. However, 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 activities described in the protocol
• 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
• Patient is diagnosed with immunodeficiency or receiving chronic steroids that are exceeding a dose that is equivalent to prednisone 10 mg daily
• Patients with symptomatic brain metastases are excluded. Patients with asymptomatic metastases or those who received treatment to the brain metastases and are off steroid therapy, can participate
• Known psychiatric or substance use that would interfere with the study requirements
• Inability to co-operate with the requirements of the protocol