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Protocol Details

A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived from Patients with Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 72 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Non-Small Cell Lung Cancer;
Lung Cancer

Recruitment Keyword(s)



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

Investigational Drug(s)

Young TIL

Investigational Device(s)



Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide
Biological/Vaccine: Young TIL

Supporting Site

National Cancer Institute


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.


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.


- Adults age 18-72 with NSCLC who have a tumor that can be safely removed.


-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.

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a. 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.)

b. 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.

c. All patients must have had at least one appropriate first line systemic therapy and progressed.

d. Clinical performance status of ECOG 0 or 1.

e. Age Greater than or equal to 18 years of age and less than or equal to 72 years of age.

f. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment.

g. Willing to sign a durable power of attorney

h. Able to understand and sign the Informed Consent Document

I. Hematology:

-Absolute neutrophil count greater than 1000/mm3 without support of filgrastim

-Normal WBC (> 2500/mm3).

-Hemoglobin greater than 8.0 g/dl. Subjects may be transfused to reach this cut-off.

-Platelet count greater than 80,000/mm3

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 RTPCR and be HCV RNA negative.

k. Chemistry:

-Serum ALT/AST less than or equal to2.5 times the upper limit of normal.

-Serum creatinine less than or equal to 1.6 mg/dl.

-Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert s Syndrome, who must have a total bilirubin less than or equal to 3 mg/dl.

l.Women of child-bearing potential 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


a. Women who are breastfeeding because of the potentially dangerous effects of the treatment on the infant.

b. Ongoing need for pharmacological immunosuppression, including steroids

c. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses.

d. Major bronchial occlusion or bleeding not amenable to palliation.

e. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency

Disease and AIDS).

f. 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.)

g. History of severe immediate hypersensitivity reaction to any of the agents used in this study.

h. For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.

i. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%

j. 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.

k. Patients who are receiving any other investigational agents.

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Delbaldo C, Michiels S, Rolland E, Syz N, Soria JC, Le Chevalier T, Pignon JP. Second or third additional chemotherapy drug for non-small cell lung cancer in patients with advanced disease. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD004569. Review. Update in: Cochrane Database Syst Rev. 2012;4:CD004569.

Boni C, Tiseo M, Boni L, Baldini E, Recchia F, Barone C, Grossi F, Germano D, Matano E, Marini G, Labianca R, Di Costanzo F, Bagnulo A, Pennucci C, Caroti C, Mencoboni M, Zanelli F, Prochilo T, Cafferata MA, Ardizzoni A; Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC). Triplets versus doublets, with or without cisplatin, in the first-line treatment of stage IIIB-IV non-small cell lung cancer (NSCLC) patients: a multicenter randomised factorial trial (FAST). Br J Cancer. 2012 Feb 14;106(4):658-65. doi: 10.1038/bjc.2011.606. Epub 2012 Jan 12.

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Principal Investigator

Referral Contact

For more information:

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

NCI SB Immunotherapy Recruitment Center
National Cancer Institute (NCI)

(866) 820-4505

Recruitment Center - SB
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Building 10, Room 2-1730, Bethesda, Maryland 20892, United States
(866) 820-4505

Clinical Trials Number:


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