A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

Prior treatment

• NSCLC with driver gene mutations for approved targeted drug indications.
• Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose.
• Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.
• Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.

Other illness

• Histologically confirmed small cell lung cancer (SCLC).
• Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
• Clinically significant cardiovascular or cerebrovascular disease.
• Known active pulmonary tuberculosis.
• Patients with active hepatitis B or active hepatitis C.
• Known medical history of immunodeficiency or positive HIV test.

Other

• Active central nervous system (CNS) metastases were present.
• Pregnant or lactating women.

• The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
• Aged ≥18 years when the subject signed the informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
• No prior systemic therapy for advanced or metastatic NSCLC was received.
• PD-L1 TPS \< 1%.
• No EGFR sensitive mutations or ALK gene translocation alterations.