IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic NSCLC or non squamous NSCLC
• Have biomarker-positive solid tumor
• Male participants of childbearing potential must agree to use an adequate method ofcontraception starting with the first dose of study medication through 120 days afterthe last dose of study medication
• Female participants of childbearing potential must be willing to use an adequatemethod of contraception for the course of the study through 120 days after the lastdose of study medication
• The participant must provide written informed consent
• Have measurable disease per RECIST 1.1
• Have provided a blood sample and archival tumor tissue sample or newly obtained coreor excisional biopsy of a tumor lesion not previously irradiated
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
• Adequate organ function

Exclusion Criteria:

• Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agentdirected to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40,CD137) and was discontinued from that treatment due to a Grade 3 or higherimmune-related AE (irAE)
• Is currently participating and receiving study therapy or has participated in a studyof an investigational agent and received study therapy or used an investigationaldevice within 4 weeks of the first dose of treatment
• Radiotherapy within 2 weeks of start of trial treatment
• Vaccination with a live vaccine within 30 days prior to the first dose of trialtreatment.Examples of live vaccines include, but are not limited to, the following:measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies,Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines forinjection are generally killed virus vaccines and are allowed; however, intranasalinfluenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.
• Is currently participating in or has participated in a trial of an investigationalagent or has used an investigational device within 4 weeks prior to the first dose oftrial treatment.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form ofimmunosuppressive therapy within 7 days prior the first dose of trial treatment.
• Has a known additional malignancy that is progressing or has required active treatmentwithin the past 2 years.
• Has known active CNS metastases and/or carcinomatous meningitis.
• Has severe hypersensitivity (≥Grade 3) to IO102, pembrolizumab, carboplatin,pemetrexed and/or any of its excipients.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has a history of (non-infectious) pneumonitis that required steroids or has currentpneumonitis.
• Has an active infection requiring systemic therapy.
• Has a known history of human immunodeficiency virus (HIV) infection.
• Known active Hepatitis B or Hepatitis C
• Has a history or current evidence of any condition, therapy, or laboratory abnormalitythat might confound the results of the trial, interfere with the patient'sparticipation for the full duration of the trial, or is not in the best interest ofthe patient to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere withcooperating with the requirements of the trial.
• Is pregnant or breastfeeding or expecting to conceive or father children within theprojected duration of the trial.