Actively Recruiting
Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-31
20
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 18 years
- Diagnosis of stage IV or recurrent non-small cell lung cancer with activating EGFR, ALK, ROS1, or ERBB2 genomic alterations
- ECOG performance status of 0 or 1
- Expected survival of at least 4 months
- Disease progression after at least one prior systemic therapy including targeted therapy if applicable
- Measurable disease excluding lesions used for TIL harvest
- Safely accessible tumor for TIL harvest estimated to yield 1.5 cm3 of tissue
- Stable or treated brain metastases if present, with size ≤10 mm or clinically stable
- Adequate organ and marrow function including specified blood counts and liver/kidney tests
- Pulmonary function with DLCO ≥45% of predicted within past 4 months
- HIV patients must be on effective therapy with undetectable viral load and normal CD4 count
- Controlled hepatitis B or cured hepatitis C infection with no cirrhosis
- Prior or concurrent malignancies allowed if they do not interfere with study assessments
You will not qualify if you...
- More than six prior lines of systemic therapy for NSCLC
- Prior treatment with PD-1 or PD-L1 inhibitors for metastatic NSCLC
- Rapidly progressing tumors as judged by investigator
- Active or recent autoimmune disease within 2 years (with some exceptions)
- Active leptomeningeal or pachymeningeal metastases or carcinomatous meningitis
- Primary immunodeficiency or recent systemic immunosuppressive therapy
- Uncontrolled serious illnesses including heart conditions and significant carotid artery stenosis
- Unresolved grade 2 or higher toxicity from prior cancer therapy
- QTc interval ≥480 ms on electrocardiogram
- Active systemic infections requiring intravenous antibiotics within 1 week
- History of allogeneic organ transplant
- Psychiatric or social situations limiting study compliance
- History of anaphylaxis to beta-lactam antibiotics
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
B
Ben Creelan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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