TIL+ Nivolumab for Non-small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FLNon-small Cell Lung Cancer+2 MoreTumor-infiltrating Lymphocytes (TIL) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Non-small Cell Lung Cancer (NSCLC), Recurrent

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Osimertinib
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Antineoplastic Immune Cell
1
Infusion of TBio-4101 TIL

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 Years

Up to 18 Months
Adverse Events (AE)
Up to 5 Years
Objective Response Rate (ORR)
Overall Survival (OS)
Up to 5 years
Duration of Response (DOR)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Osimertinib
1
Antineoplastic Immune Cell
1
Infusion of TBio-4101 TIL

Trial Design

1 Treatment Group

TIL+ Nivolumab
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: TIL+ Nivolumab · No Placebo Group · Phase 1 & 2

TIL+ NivolumabExperimental Group · 6 Interventions: Tumor-infiltrating Lymphocytes (TIL), Nivolumab, Cyclophosphamide, Fludarabine, Tumor-infiltrating Lymphocyte Therapy, Interleukin-2 (IL2) · Intervention Types: Biological, Drug, Drug, Drug, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4480
Cyclophosphamide
1995
Completed Phase 3
~3920
Fludarabine
2012
Completed Phase 3
~1100

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
510 Previous Clinical Trials
126,932 Total Patients Enrolled
5 Trials studying Non-small Cell Lung Cancer
223 Patients Enrolled for Non-small Cell Lung Cancer
Ben Creelan, MD, MSPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
28 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 14 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had or currently have another type of cancer, but it will not affect the safety or effectiveness of the study treatment.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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