Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC

Inclusion Criteria: * Age ≥18 years. * Pathologically confirmed stage IV NSCLC (squamous or nonsquamous). * No prior systemic chemotherapy for advanced/metastatic NSCLC. * Tumor lacks an actionable genomic alteration with approved first-line targeted therapy (EGFR, ALK etc.; AGA status from local or central testing; ctDNA acceptable if tissue unavailable). * PD L1 result available before randomization: TPS ≥1%, \<1%, or unknown. * ECOG performance status 0-1. * At least one measurable lesion per RECIST v1.1. * Able to attend visits and follow-up. * Contraception requirements for women of childbearing potential and nonsterile males, with 7 month post-last-dose window. Exclusion Criteria: * Body weight \<40 kg. * Serious uncontrolled concomitant disease. * Certain prior malignancies (exceptions: adequately treated or nonmetastatic, as per protocol). * Active autoimmune disease requiring systemic treatment (exceptions: autoimmune thyroiditis, etc.). * Prior organ transplant requiring immunosuppression. * Prior pneumonitis/interstitial lung disease requiring active systemic treatment. * Prior systemic chemotherapy or immunotherapy within 3 years. * Requirement for other anticancer therapy while on study (palliative RT allowed). * Known CNS metastases, carcinomatous meningitis, and/or spinal cord compression (with specified exceptions for treated or asymptomatic brain mets). * HIV infection or active/uncontrolled HBV/HCV not meeting the protocol's controlled criteria. * Active …