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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07355205
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Non-small Cell Lung Cancer Recurrent
  • Non-small Cell Lung Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab will be given intravenously at a dose of 1mg/kg.
  • Nivolumab — DRUG
    Nivolumab will be given intravenously at a dose of 360mg.
  • Nogapendekin alfa inbakicept — DRUG
    Nogapendekin alfa inbakicept will be given subcutaneously at the assigned dose level.

Study Details

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.

Key Dates

First listed
Jan 21, 2026
Start date
Jul 7, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2032
Completion
Jul 31, 2032

Study Design

Enrollment
26 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib Dose Level 1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803)
    Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks).
  • Experimental: Phase Ib Dose Level -1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803)
    Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks).
  • Experimental: Phase II: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803)
    Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks).

Primary Outcome Measure

Progression-free survival (PFS) (Phase Ib acceptable dose participants and Phase II participants) [ Time Frame: Start of treatment through 2 years after end of treatment (up to 4 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Giordano Fabricio Cittolin Santos, MD, PhD
[email protected]
314-273-4731
Giordano Fabricio Cittolin Santos, MD, PhD (PRINCIPAL_INVESTIGATOR)
Daniel Morgensztern, MD (SUB_INVESTIGATOR)
Maria Q Baggstrom, MD (SUB_INVESTIGATOR)
Brett Herzog, MD, PhD (SUB_INVESTIGATOR)
Anjali Rohatgi, MD (SUB_INVESTIGATOR)
Saiama N Waqar, MD (SUB_INVESTIGATOR)
Jeffrey Ward, MD, PhD (SUB_INVESTIGATOR)
Danielle Turlington, PharmD, BCOP (SUB_INVESTIGATOR)
Ningying Wu, PhD (SUB_INVESTIGATOR)

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Washington University School of Medicine· St Louis, MO

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