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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: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

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 a dose of 15 μg/kg.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    collaborator INDUSTRY

  • The Foundation for Barnes-Jewish Hospital

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2032-06-30
Completion
2032-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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