Second or third additional chemotherapy drug for non-small cell lung cancer in patients with advanced disease.
Catherine Delbaldo, Stefan Michiels, Estelle Rolland...
https://pubmed.ncbi.nlm.nih.gov/17943820Actively Recruiting
Phase 2
Age: 18Years - 72Years
All Genders
ID02133196
A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen
Led by National Cancer Institute (NCI) · Updated on 2026-06-08
85
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating an experimental treatment for advanced non-small cell lung cancer (NSCLC) using specially selected tumor-infiltrating lymphocytes (TIL), a type of white blood cell from the patient's own tumor. This study aims to determine if these TIL cells can shrink tumors and assess the safety of the treatment in patients aged 18 to 72 with resectable tumors. The study is a Phase II trial sponsored by the National Cancer Institute (NCI). Participants will first undergo outpatient evaluations including exams, scans, and lab tests. If eligible, patients will have surgery to remove a tumor for growing the TIL cells and may also undergo leukapheresis to collect additional white blood cells. Following cell growth, patients receive a non-myeloablative lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine, then an infusion of the TIL cells intravenously on Day 0. Patients are assigned to receive either high-dose or low-dose aldesleukin intravenously after the cell infusion, with dosing schedules based on individual health considerations. Hospitalization for about four weeks is required during treatment. After treatment, participants return for regular follow-up visits including physical exams, side effect reviews, lab tests, and scans every 1 to 3 months during the first year, then every 6 to 12 months if tumors continue to shrink. These visits can last up to two days. Researchers will evaluate tumor response rates at multiple time points, monitor treatment side effects, and study the characteristics and feasibility of generating TIL cells. The total study duration includes initial work-up, treatment, and long-term follow-up to assess outcomes and safety.
CONDITIONS
Brief Title
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
Who Can Participate
Age: 18Years - 72Years
All Genders
Eligibility Criteria
You may qualify if you...
- Measurable metastatic or unresectable non-small cell lung cancer with at least one lesion that can be removed for TIL growth
- Three or fewer brain metastases less than 1 cm and asymptomatic, or stable after treatment
- Completed at least one prior systemic therapy with disease progression
- Clinical performance status of ECOG 0 or 1
- Age between 18 and 72 years
- Willingness to use birth control during and after treatment as specified
- Willing to sign a durable power of attorney
- Able to understand and sign informed consent
- Adequate blood counts and normal white blood cell levels
- Negative tests for HIV, hepatitis B, and hepatitis C as specified
- Liver and kidney function within defined limits
- Negative pregnancy test for individuals of childbearing potential
- Completed prior systemic therapy at enrollment
- Recovery from any recent minor surgery or local radiotherapy to grade 1 or less toxicity
- More than two weeks since any major bronchial palliation with recovery to grade 1 or less
- Co-enrollment in protocol 03-C-0277
You will not qualify if you...
- Currently nursing
- Need for ongoing pharmacological immunosuppression including steroids
- Active systemic infections or major medical illnesses
- Major bronchial occlusion or bleeding not treatable
- Any primary immunodeficiency such as severe combined immunodeficiency or AIDS
- Concurrent opportunistic infections
- History of severe allergic reaction to study agents
- Low heart function (LVEF ≤ 45%) if clinically indicated
- Low lung function (FEV1 ≤ 50%) if clinically indicated
- More than two prior invasive thoracic procedures, poor exercise tolerance, over 66 years of age, or other significant conditions excluding high-dose Aldesleukin
- Receiving other investigational agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 2 weeks including preparative regimen and aldesleukin dosing
Participants undergo a non-myeloablative lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine followed by infusion of autologous young tumor-infiltrating lymphocytes (TIL) and receive high-dose or low-dose aldesleukin intravenously.
Multiple visits including 5 days of preparative chemotherapy and 1 day for TIL infusion followed by up to 9 doses (high-dose) or 12 doses (low-dose) of aldesleukin over several days
Follow-up
Duration - Up to 2 years with ongoing assessments
Participants are followed to evaluate tumor response and monitor safety after cell infusion.
Visits at about 4-6 weeks after infusion, then every 3 months for 9 months, then every 6 months up to 2 years
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
N
NCI SB Immunotherapy Recruitment Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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