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

NCT05681780 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-31

No results posted yet for this study

Summary

To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.

Conditions

  • Non Small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Recurrent Non Small Cell Lung Cancer

Interventions

BIOLOGICAL

Tumor-infiltrating Lymphocytes (TIL)

Tumor harvest for TIL growth in the lab: A sample of the participant's tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.

DRUG

Nivolumab

Nivolumab (Opdivo®), 360 mg, IV infusion every 3 weeks prior to TIL infusion, and then after TIL infusion 480 mg ever 4 weeks for up to 12 months.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered on days -7 and -6.

DRUG

Fludarabine

Fludarabine will then be infused per institutional standard on Days -7 to -3.

OTHER

Tumor-infiltrating Lymphocyte Therapy

On day 0, all patients will receive a dose infusion TIL cells.

DRUG

Interleukin-2 (IL2)

Participants will receive IL-2 for up to 6 doses, based on participants tolerance and investigator judgement. This will be given after the infusion of the T-cells.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Ben Creelan, MD, MS · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-10
Primary Completion
2026-06-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681780 on ClinicalTrials.gov