T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
Launched by NATIONAL CANCER INSTITUTE (NCI) · May 6, 2014
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new treatment for patients with advanced non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread beyond its original site. The researchers are using a special method called T cell receptor immunotherapy. They will take certain white blood cells from the patient's tumor, grow them in the lab to increase their numbers, and then return these cells to the patient to help fight the cancer. The main goal is to see if these specially selected cells can shrink tumors and to check if the treatment is safe for patients.
To participate in this study, patients need to be between 18 and 72 years old and have a specific type of NSCLC that can be surgically removed. They should have already tried at least one other treatment for their cancer. If eligible, patients will have a series of tests, undergo surgery to remove a tumor, and then receive the treatment in the hospital over about four weeks. After treatment, there will be regular follow-up visits to monitor their health and the response of their tumors. This trial aims to find out if this innovative approach can provide a new option for people battling advanced lung cancer.
Gender
ALL
Eligibility criteria
- * INCLUSION CRITERIA:
- • 1. Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation. (Note: neuroendocrine tumors are not eligible.)
- • 2. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
- • 3. All patients must have had at least one appropriate first line systemic therapy and progressed.
- • 4. Clinical performance status of ECOG 0 or 1.
- • 5. Age \>= 18 years of age and \<= 72 years of age.
- • 6. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for individuals of childbearing potential (IOCBP) and for four months after treatment for individuals able to father a child.
- • 7. Willing to sign a durable power of attorney
- • 8. Able to understand and sign the Informed Consent Document
- I. Hematology:
- • 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
- j. Serology:
- • 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.
- k. Chemistry:
- • 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.
- • l. IOCBP must have a negative pregnancy test or evidence that they are not pregnant (e.g., ultrasound or serial HCG measurements) prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.
- • m. Patients must have completed any prior systemic therapy at the time of enrollment.
- • Note: Patients may have undergone minor surgical procedures or local radiotherapy within the past 4 weeks, as long as related major organ toxicities have recovered to grade 1 or less.
- • n. More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient's toxicities must have recovered to a grade 1 or less.
- • o. Subjects must be co-enrolled in protocol 03-C-0277.
- EXCLUSION CRITERIA:
- • 1. Participants who are nursing because of the potentially dangerous effects of the treatment on the infant.
- • 2. Ongoing need for pharmacological immunosuppression, including steroids
- • 3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses
- • 4. Major bronchial occlusion or bleeding not amenable to palliation.
- • 5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency
- • Disease and AIDS).
- • 6. 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.)
- • 7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- • 8. For select patients with a clinical history prompting cardiac evaluation: last known LVEF \<= 45%.
- • 9. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 \<= 50%
- 10. 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.
- • 11. Patients who are receiving any other investigational agents.
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Trial Officials
James C Yang, M.D.
Principal Investigator
National Cancer Institute (NCI)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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