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

NCT07355205 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-07-10

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Ipilimumab

Ipilimumab will be given intravenously at a dose of 1mg/kg.

DRUG

Nivolumab

Nivolumab will be given intravenously at a dose of 360mg.

DRUG

Nogapendekin alfa inbakicept

Nogapendekin alfa inbakicept will be given subcutaneously at the assigned dose level.

Sponsors & Collaborators

Principal Investigators

  • Giordano Fabricio Cittolin Santos, MD, PhD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-07
Primary Completion
2032-07-31
Completion
2032-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07355205 on ClinicalTrials.gov