A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer

Inclusion criteria

• 18 to 75 years old.
• Have a life expectancy of at least 3 months.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.
• Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered.
• No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
• Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator.
• Has adequate organ function.

Exclusion criteria

• Undergone major surgery within 30 days prior to the first dose of study treatment.
• Active central nervous system (CNS) metastases.
• History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
• Active Hepatitis B or Hepatitis C.
• Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
• Has received treatment with docetaxel.
• History of severe bleeding tendency or coagulation disorder.