T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer

Recruiting now · Phase 2

Conditions studied: Advanced Non-Small Cell Lung Cancer, Squamous Cell Carcinoma, Advanced NSCLC, Adenosquamous Carcinoma, Adenocarcinoma

In brief

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.

Key facts

Study ID: NCT02133196
Run by: National Cancer Institute (NCI)
People needed: 85
Starts: 2014-10-23
Expected to finish: 2027-10-23
Last updated by the study team: 2026-06-08

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Participants who are nursing because of the potentially dangerous effects of the treatment on the infant.
Ongoing need for pharmacological immunosuppression, including steroids
Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses
Major bronchial occlusion or bleeding not amenable to palliation.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency
Disease and AIDS).
Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
History of severe immediate hypersensitivity reaction to any of the agents used in this study.
For select patients with a clinical history prompting cardiac evaluation: last known LVEF <= 45%.
For select patients with a clinical history prompting pulmonary evaluation: known FEV1 <= 50%
Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm:
Greater than 2 invasive thoracic procedures
Poor exercise tolerance
Greater than 66 years of age
Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate high-dose.
Patients who are receiving any other investigational agents.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.