Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria: Subjects enroll in the study and sign the Informed Consent Form (ICF); Aged ≥18 years and ≤75 years; histologically or cytologically confirmed advanced non-small cell lung cancer without driver genes (diagnostic criteria refer to AJCC 8th edition of squamous or non-squamous non-small cell lung cancer); Subjects with an Eastern Cooperative Oncology Group (ECOG) score of 0 ~1 for physical status; expected survival ≥ 12 weeks; Subjects with measurable lesions (at least 1 extracranial lesion) according to the Solid Tumor Evaluation Criteria (RECIST v1.1). Subjects provide formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections (at least 6), either archived or freshly obtained within 5 years prior to the first study treatment (freshly obtained is preferred); Organ function meets the following criteria: Adequate bone marrow reserve (not acceptable for corrective therapy with hematologic products or cell growth factors administered within 14 days prior to first study dose): absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 90 x 109/L, and hemoglobin ≥ 9 g/dL; Liver: serum albumin ≥ 3.0 g/dL; total bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN), and ALT and AST ≤ 3 times the ULN (or AST and ALT ≤ 5 × ULN for patients with known liver metastases); Renal: blood creatinine ≤ 1.25 times ULN; Heart: left ventricular ejection fraction (LVEF) ≥ 50%. Subjects of childbearing potential must be using highly effective contraception during the study and for at least 6 months after the last dose; female subjects of childbearing potential must have a negative blood pregnancy test within 3 days prior to study enrollment. Exclusion Criteria: Severe immunotherapy-related toxicity during prior treatment with anti-ICIs; Prior grade ≥ 3 irAE on immunotherapy and who have not recovered to grade ≤ 1 from the last adverse reaction to antineoplastic therapy; With primary or secondary immunodeficiency； Any active, known or suspected autoimmune disease; Known CNS metastases ; Prior severe allergic reactions to large protein preparations/monoclonal antibodies (CTCAE V5.0 classification ≥ grade 4); Previous treatment with anti-LAG-3 antibodies; Other malignant tumors within 5 years prior to screening, except cured cervical carcinoma in situ and cured basal cell carcinoma of the skin; Have uncontrolled cardiac clinical symptoms or disease； Subjects have received a live attenuated vaccine (except inactivated viral seasonal influenza vaccine and novel coronavirus vaccine) within 4 weeks prior to the first dose and who will not receive intranasally administered live attenuated influenza vaccine; Pregnant or nursing females； Poorly compliant or otherwise unsuitable for participation in this study.