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

This study is testing an experimental treatment for advanced non-small cell lung cancer (NSCLC), including squamous cell carcinoma, adenosquamous carcinoma, and adenocarcinomas. Researchers will take white blood cells from your tumor, grow them in the lab, and then give them back to you. These cells, called Tumor Infiltrating Lymphocytes (TIL), are specially selected to fight cancer. Before receiving the TIL cells, you will get chemotherapy with Fludarabine and Cyclophosphamide. After the TIL cells, you will receive Aldesleukin. The main goal is to see if this treatment can shrink your tumors and if it is safe. You may be eligible if you are between 18 and 72 years old and have metastatic or unresectable NSCLC with a tumor that can be removed for TIL generation. The study aims to enroll 85 participants.

Study design
This is an interventional study with a planned enrollment of 85 participants. It involves different doses of Aldesleukin in two arms.
What's involved
You will receive chemotherapy (Fludarabine and Cyclophosphamide) for several days, followed by an intravenous infusion of TIL cells. You will then receive Aldesleukin for up to 9 or 12 doses.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured at 6 and 12 weeks after cell infusion, then every 3 months for 9 months, then every 6 months for 2 years, and then as decided by the doctor.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02133196

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

Recruiting
PHASE2Ages 18–72InterventionalTreatment
National Cancer Institute (NCI)
~85 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:AldesleukinFludarabineCyclophosphamideYoung TIL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate
Measured over 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion

Conditions

Advanced Non-Small Cell Lung Cancer
Squamous Cell Carcinoma
Advanced NSCLC
Adenosquamous Carcinoma
Adenocarcinoma

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • James C Yang, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

NCI SB Immunotherapy Recruitment Center
[email protected]
(866) 820-4505
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute neutrophil count \> 1000/mm\^3 without support of filgrastim
Normal WBC (\>= 2500/mm\^3).
Hemoglobin \> 8.0 g/dl. Subjects may be transfused to reach this cut-off.
Platelet count \>= 80,000/mm\^3
Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)
Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
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.

Exclusion

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. 11. Patients who are receiving any other investigational agents.

What this trial measures

  • Response rate6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion

    Percentage of patients who have a clinical response to treatment (objective tumor regression)