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 infection requiring IV therapy.
* Inadequate organ function:
* ANC \<1,500/mm³; platelets \<100,000/mm³; Hgb \<9 g/dL.
* Total bilirubin \>1.5×ULN (with defined Gilbert's exception).
* AST/ALT \>1.5×ULN (or \>5×ULN with liver mets).
* ALP \>2.5×ULN (or \>5×ULN with bone mets).
* Creatinine clearance \<40 mL/min (Cockcroft-Gault).
* Significant cardiovascular disease (uncontrolled HTN, recent MI, stroke, CHF ≥NYHA II, serious arrhythmia).
* Known hypersensitivity to study drugs.
* Concomitant medications known to interact adversely with study drugs.
* Participation in another investigational drug/device study (except hormone-lowering therapy).
* Pregnancy or breastfeeding.
* Confinement by court order/authority.
* Any condition or noncompliance that, in Investigator judgment, precludes participation.