drugset
drugset / Trial / NCT07524257

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

NCT07524257 ↗

Phase 3 Withdrawn ImmunityBio, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-29
Primary completion
2029-05-15
Completion
2029-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject N-803 Protein / enzyme biologic 15 ug/kg Subcutaneous
Subject N-803 Protein / enzyme biologic 1.2 mg Subcutaneous
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

non-small cell lung carcinoma