First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

This is a single center, phase Ib/II study combining an anti-PD-1 antibody and an anti-CTLA-4 antibody with IL-15. It is testing the hypothesis that the addition of nogapendekin alfa inbakicept to nivolumab and ipilimumab will augment the clinical activity of those two drugs.

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC.

Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a CLIA-certified test. Results of the PD-L1 testing are not required for enrollment.

Measurable disease per RECIST 1.1.

At least 18 years of age.

Disqualifiers

Mixed histology including small cell lung cancer.

classic EGFR mutations

HER2 mutation

ALK fusion

Trial design

Treatments tested in this trial

  • Ipilimumab
  • Nivolumab
  • Nogapendekin alfa inbakicept

Treatment groups

26 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Washington University School of Medicine

Lead sponsor

ImmunityBio, Inc.

Collaborator

The Foundation for Barnes-Jewish Hospital

Collaborator