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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE3

Sponsor: ImmunityBio, Inc.

Summary

This is a randomized, open-label, phase 3 study evaluating nogapendekin alfa inbakicept (NAI) plus chemoimmunotherapy containing pembrolizumab and platinum-based chemotherapy versus chemoimmunotherapy alone as first-line treatment in patients with stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Primary endpoint is progression-free survival by RECIST v1.1 based on blinded independent central review.

Eligibility Criteria

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%, \1.5×ULN (or \>5×ULN with liver mets). * ALP \>2.5×ULN (or \>5×ULN with bone mets). * Creatinine clearance \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07524257). StuddyBuddy aggregates publicly available trial information.