OncoMatch/Clinical Trials/NCT02133196
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
Is NCT02133196 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Young TIL and Aldesleukin for advanced non-small cell lung cancer.
Treatment: Aldesleukin · Fludarabine · Cyclophosphamide · Young TIL — Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100 patients. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is safe. Eligibility: \- Adults age 18-72 with NSCLC who have a tumor that can be safely removed. Design: * Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed * Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. * Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} * Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — first line
All patients must have had at least one appropriate first line systemic therapy and progressed.
Lab requirements
Blood counts
Absolute neutrophil count > 1000/mm^3 without support of filgrastim; WBC >= 2500/mm^3; Hemoglobin > 8.0 g/dl (may be transfused to reach this cut-off); Platelet count >= 80,000/mm^3
Kidney function
Serum creatinine <= 1.6 mg/dl.
Liver function
Serum ALT/AST <= 2.5 times the upper limit of normal. Total bilirubin <= 2 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin <= 3 mg/dl.
Absolute neutrophil count > 1000/mm^3 without support of filgrastim; WBC >= 2500/mm^3; Hemoglobin > 8.0 g/dl. Subjects may be transfused to reach this cut-off; Platelet count >= 80,000/mm^3; Serum ALT/AST <= 2.5 times the upper limit of normal; Serum creatinine <= 1.6 mg/dl; Total bilirubin <= 2 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin <= 3 mg/dl.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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