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
PHASE2
Status
Not Yet 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 a dose of 15 μg/kg.

Study Details

This is an open-label, single center, one cohort, non-randomized, phase II study. The aim of the study is to evaluate the efficacy and safety of the combination of nivolumab and ipilimumab with nogapendekin alfa inbakicept in patients with stage IV or recurrent non-small cell lung cancer (NSCLC). It is hypothesized that the study treatment will be safe and well tolerated and will improve progression-free survival when compared to a historical study which treated advanced NSCLC patients with nivolumab plus ipilimumab. Patients will be treated in cycles lasting 6 weeks with two to three different chemotherapy drugs to up to 24 months.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 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) [ 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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By research site
Washington University School of Medicine· St Louis, MO

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