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Checkpoint Inhibitor

TIL + Nivolumab for Lung Cancer

Phase 1 & 2

Recruiting

Led By Daniel Abate Daga, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 or 1

Participants must have had disease progression after at least one prior line of systemic therapy for NSCLC, including appropriate prior targeted therapy for cases in which a targeted therapy is conventionally used for this genomic alteration, prior to initiating nivolumab trial therapy

Must not have

No prior PD-1 or PD-L1 inhibitor treatment for metastatic NSCLC. Examples of inhibitors include: nivolumab, atezolizumab, pembrolizumab, avelumab, cemplimumab, spartalizumab, or durvalumab.

No more than six prior lines of systemic therapy for NSCLC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special cell preparation to treat genomically altered lung cancer with a drug called nivolumab.

Who is the study for?

This trial is for adults over 18 with stage IV or recurrent NSCLC who have specific genetic alterations (EGFR, ALK, ROS1, HER2) and have progressed after at least one systemic therapy. They must have a tumor that can be biopsied for TIL harvest and adequate organ function. Those with certain heart conditions, uncontrolled illnesses, more than six prior NSCLC therapies, previous PD-1/PD-L1 inhibitor treatment for metastatic NSCLC or active infections are excluded.

What is being tested?

The trial tests the effectiveness of CD40L-stimulated TILs combined with nivolumab in patients with genetically altered lung cancer. It aims to see how well these specially prepared immune cells work when given alongside an established immunotherapy drug.

What are the potential side effects?

Potential side effects include reactions from the cell infusion such as fever and chills, fatigue from interleukin-2 or fludarabine treatments, possible damage to organs due to nivolumab's effect on the immune system which might cause inflammation in various parts of the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My NSCLC worsened after treatment, including targeted therapy if applicable.

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You need to have normal blood and organ function, including specific levels of red blood cells, white blood cells, platelets, and certain liver and kidney function tests. You should also have certain levels of lung function and specific requirements related to HIV, hepatitis B and C, and any history of other cancers.

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I am 18 years old or older.

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My lung cancer is stage IV or recurrent with specific genetic changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken drugs like nivolumab or pembrolizumab for my lung cancer.

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I have had 6 or fewer treatments for my lung cancer.

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I do not have any severe illnesses like heart failure or major artery blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events (AE)

Secondary study objectives

Duration of Response (DOR)

Objective Response Rate (ORR)

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TIL+ NivolumabExperimental Treatment6 Interventions

Nivolumab infusion every 3 weeks prior to lymphodepletion chemotherapy with cyclophosphamide/fludarabine, TIL infusion and interleukin-2. Then nivolumab infusion every 4 weeks up to 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Tumor-infiltrating Lymphocytes (TIL)

2017

Completed Phase 1

~20