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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events (AE)

Secondary outcome measures

Duration of Response (DOR)

Objective Response Rate (ORR)

Overall Survival (OS)

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

Interleukin-2 (IL2)

2017

Completed Phase 1

~20

Cyclophosphamide

1995

Completed Phase 3

~3770

Nivolumab

2014

Completed Phase 3

~4750

Tumor-infiltrating Lymphocytes (TIL)

2017

Completed Phase 1

~20

Fludarabine

2012

Completed Phase 3

~1100

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,462 Total Patients Enrolled

Daniel Abate Daga, PhDPrincipal InvestigatorMoffitt Cancer Center

Ben Creelan, MD, MSPrincipal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

28 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05681780 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: TIL+ Nivolumab

Non-Small Cell Lung Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05681780 — Phase 1 & 2

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05681780 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still underway for this experiment?

"Correct. According to clinicaltrials.gov, this medical trial was originally posted on December 23rd 2022 and is actively recruiting participants; the study requires 20 individuals from a single centre."

Answered by AI

Can you provide the aggregate number of participants currently enrolled in this trial?

"Indeed, the information hosted on clinicaltrials.gov indicates that this medical study is recruiting patients as of December 28th 2022. Initially posted on December 23rd 2020, it seeks to enrol 20 individuals at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

2023. "Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05681780.