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NCT02133196 · ClinicalTrials.gov registry record · Phase 2
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
A Phase 2 study of Squamous Cell Carcinoma and Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT02133196 is a Phase 2 study of Squamous Cell Carcinoma and Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 85 participants, below the 102-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02133196, a Phase 2 study of Squamous Cell Carcinoma and Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study 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. ...
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- BIOLOGICAL Young TIL
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2014-10-23 |
| Est. Completion | 2027-10-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02133196
The ClinicalTrials.gov registry entry for NCT02133196 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 102-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (17% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02133196 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02133196 about?
NCT02133196 is a clinical study titled "T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer". 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...
What is the current status of trial NCT02133196?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2014-10-23. Estimated completion is 2027-10-23.
What conditions does trial NCT02133196 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma, Adenocarcinoma, Advanced Non-Small-Cell Lung Cancer, Adenosquamous Carcinoma, Advanced NSCLC.
What interventions are being tested in trial NCT02133196?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), Young TIL (BIOLOGICAL).
Who is sponsoring clinical trial NCT02133196?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02133196 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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