A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

Inclusion criteria

• Subjects must sign the written informed consent form (ICF) voluntarily.
• Age ≥18 years.
• Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
• Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
• Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
• Chemotherapy regimens should be in accordance with current clinical guidelines.
• Consolidation chemotherapy is not allowed after radiotherapy.
• Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
• No disease progression after concurrent or sequential chemoradiotherapy.
• ECOG performance status score of 0-1.
• Expected survival of over 3 months.
• Adequate organ and bone marrow function.

Exclusion criteria

• The histopathology contains any component of small cell lung cancer.
• Currently participating in another interventional clinical study.
• Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
• Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
• Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
• Tumor invades important vessels or organs.
• Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.
• Presence of interstitial lung disease that requires treatment.
• Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
• Experienced severe infection within 4 weeks prior to the first dose.
• Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose.
• Any condition that required systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.