Clinical Research Directory

Inclusion Criteria: * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * ≥18 years old and ≤75 years old (at the time consent is obtained). * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has a life expectancy of at least 3 months. * Has a histologically confirmed diagnosis of squamous NSCLC. * Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer \[AJCC\]). * Has no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. * Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Has adequate organ function. Exclusion Criteria: * Histological diagnosis of non-squamous NSCLC. * Has EGFR-sensitive mutations or ALK gene translocations. * Known ROS1 rearrangement, MET exon 14 skipping mutation, or RET gene fusion positivite. * Is currently participating in a study of an investigational agent or using an investigational device. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment. * Has undergone major surgery within 30 days of Study Day 1. * Has known active central nervous system (CNS) metastases. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Has an active infection requiring systemic therapy. * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Has received a live virus vaccine within 30 days of the planned first dose of study therapy. * Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.