Ipilimumab + Nivolumab + Nogapendekin for Lung Cancer

(FLINN Trial)

Overseen By Giordano Fabricio Cittolin Santos, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Corticosteroids, Immunosuppressives, Live vaccines, others

Disqualifiers: Small cell lung cancer, EGFR mutation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Giordano Fabricio Cittolin Santos, MD, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with advanced or recurrent non-small cell lung cancer (NSCLC). Participants should not have had prior treatment for this stage of cancer. Specific criteria will determine eligibility, and those who meet the conditions can join the study.

Inclusion Criteria

I can provide previous biopsy samples or am willing to have a biopsy for study purposes.

Measurable disease per RECIST 1.1

People of childbearing potential and people able to father a child must agree to use highly effective methods of contraception, according to the protocol, from the time of consent through 6 months after the last dose of study treatment

Exclusion Criteria

I have chronic hepatitis B but it's under control with medication.

I either have untreated hepatitis C, or I've been treated and cured, or I'm currently being treated with an undetectable viral load.

Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab intravenously on Days 1 and 22, ipilimumab IV on Day 1, and nogapendekin alfa inbakicept subcutaneously on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab is discontinued after Cycle 4, and patients continue with nivolumab and nogapendekin alfa inbakicept for up to 2 years.

24 months

Visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Ipilimumab
• Nivolumab
• Nogapendekin alfa inbakicept

Trial Overview

The trial tests a combination of two immunotherapy drugs, Ipilimumab and Nivolumab, with an additional agent called Nogapendekin alfa inbakicept. It's a phase II study to see if this mix improves survival without cancer progression compared to previous treatments.

How Is the Trial Designed?

Group I: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) Experimental Treatment 3 Interventions

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).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

ImmunityBio, Inc.

Industry Sponsor

Trials

75

Recruited

5,000+

Richard Adcock

ImmunityBio, Inc.

Chief Executive Officer since 2024

Information not available

Dr. Patrick Soon-Shiong

ImmunityBio, Inc.

Chief Medical Officer since 2021

MD

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+