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Aldesleukin / Advanced Non Small Cell Lung Cancer / Advanced NSCLC · Phase 2 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 registration for a T-cell receptor immunotherapy (tumor-infiltrating lymphocytes, TIL) in metastatic non-small cell lung cancer. No results have been posted in the registry record; the trial is actively recruiting and has not yet reported outcomes. The evidence cannot be evaluated until efficacy and safety data are published.
Phase 2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Advanced Non-Small Cell Lung Cancer, Squamous Cell Carcinoma, Advanced NSCLC, Adenosquamous Carcinoma, Adenocarcinoma; age from 18 Years; to 72 Years. Intervention: 1/High-Dose Aldesleukin; 2/Low-Dose Aldesleukin. n = 85. 1 site: United States.
This is a Phase 2 registration for a T-cell receptor immunotherapy (tumor-infiltrating lymphocytes, TIL) in metastatic non-small cell lung cancer. No results have been posted in the registry record; the trial is actively recruiting and has not yet reported outcomes. The evidence cannot be evaluated until efficacy and safety data are published.
No blinding is mentioned; no adverse event data are reported in the registry.
Clinicians should not interpret this registry record as evidence of efficacy or safety; results must be awaited from publication before clinical decisions can be informed. The approach of selecting T-cell receptor-expressing TIL represents an experimental refinement to adoptive cell therapy.
This is a Phase 2 trial registration with no posted results; the study is actively recruiting and has not yet reported efficacy or safety outcomes.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should not interpret this registry record as evidence of efficacy or safety; results must be awaited from publication before clinical decisions can be informed. The approach of selecting T-cell receptor-expressing TIL represents an experimental refinement to adoptive cell therapy.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT02133196). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 85 participants (ESTIMATED). Conditions: Advanced Non-Small Cell Lung Cancer, Squamous Cell Carcinoma, Advanced NSCLC, Adenosquamous Carcinoma, Adenocarcinoma. Interventions: DRUG: Aldesleukin; DRUG: Fludarabine; DRUG: Cyclophosphamide; BIOLOGICAL: Young TIL. Primary outcome measures: Response rate , 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.