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)
Washington University School of Medicine
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC. * Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a CLIA-certified test. Results of the PD-L1 testing are not required for enrollment. * Measurable disease per RECIST 1.1. * At least 18 years of age. * ECOG performance status ≤ 1 * Adequate organ and marrow function, as defined below: * Absolute neutrophil count ≥ 1.5 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobin ≥ 9.0 g/dL * AS…
Interventions
- DrugIpilimumab
Ipilimumab will be given intravenously at a dose of 1mg/kg.
- DrugNivolumab
Nivolumab will be given intravenously at a dose of 360mg.
- DrugNogapendekin alfa inbakicept
Nogapendekin alfa inbakicept will be given subcutaneously at a dose of 15 μg/kg.
Location
- Washington University School of MedicineSt Louis, Missouri