NCT07355205

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

A Phase II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-31
• Primary completion: 2032-03-31
• Completion: 2032-03-31
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study