Actively Recruiting

Phase 2
Age: 18Years - 72Years
All Genders
NCT02133196

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

85

Participants Needed

1

Research Sites

678 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 72Years
All Genders

Eligibility Criteria

Eligible

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 cell growth
  • Three or fewer brain metastases less than 1 cm and asymptomatic, or stable after treatment
  • Received at least one prior systemic therapy and cancer has progressed
  • Clinical performance status of ECOG 0 or 1
  • Age between 18 and 72 years
  • Willingness to practice birth control during and after treatment as specified
  • Willing to sign durable power of attorney
  • Able to understand and sign informed consent
  • Adequate blood counts and normal white blood cell levels
  • Negative tests for HIV, active hepatitis B, and hepatitis C
  • Liver and kidney function within specified limits
  • Negative pregnancy test for individuals of childbearing potential
  • Completed prior systemic therapy before enrollment
  • Recovery from 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
Not Eligible

You will not qualify if you...

  • Nursing due to potential risk to infant
  • Need for ongoing immunosuppressive drugs including steroids
  • Active systemic infections or major uncontrolled medical illnesses
  • Major bronchial obstruction or bleeding not manageable by palliation
  • Primary immunodeficiency or AIDS
  • Opportunistic infections
  • History of severe allergic reactions to study agents
  • Low heart function if cardiac history exists (LVEF ≤ 45%)
  • Low lung function if pulmonary history exists (FEV1 ≤ 50%)
  • More than two invasive chest procedures, poor exercise tolerance, age over 66, or other significant issues preventing high-dose aldesleukin use (may qualify for low-dose arm)
  • Receiving other investigational treatments

AI-Screening

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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

CONTACT

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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