AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

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.