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Investigator(s):
Giuseppe Giaccone, M.D., Ph.D. Principal Investigator Phone: 301-496-4916 Fax: 301-402-0172 giacconeg@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov	Arlene Berman, R.N., M.S., O.C.N. Research Nurse Phone: 301-435-5609 arleneb@mail.nih.gov	Corrine Keen, R.N., M.S., O.C.N. Research Nurse Phone: 301-496-3778 ckeen@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed stage IIIA (T3N2 only), IIIB and IV non-small cell lung cancer
• Stable disease or objective response to prior single, front-line, platinum-based chemotherapy regimen consisting of up to six treatment cycles with or without concomitant radiotherapy or other anticancer therapy
• No evidence of brain metastases
• No painful bone metastases, or bone metastases that require immediate therapy
• No significant and/or symptomatic pleural effusions, defined as clinically detectable (by physical exam) third-space fluid collections that cannot be controlled by prior chemotherapy and/or drainage or other procedures
• Recovered from all prior treatment
• No prior splenectomy
• No concurrent systemic steroids > 2 mg/day prednisone (or prednisone-equivalent of prednisolone or dexamethasone)
• 18 to 75 years of age
• Performance Status (ECOG) ≤ 2
• Absolute neutrophil count ≥ 1,500/mm³
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/mm³
• Albumin ≥ 3.5 g/dL
• Bilirubin ≤ 1.5 x the upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x ULN
• Creatinine ≤ 1.5 x ULN
• Alkaline phosphatase ≤ 5 x ULN
• No medical condition that would preclude study participation
• No known allergy to eggs or soy
• No significant weight loss ≥ 10% body weight in preceding 6 weeks
• HIV negative
• No peripheral neuropathy > grade 2 according to NCI CTC
• No other prior malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years
• Not pregnant or nursing; fertile patients must use effective contraception during and for 3 months after completion of study treatment
• No known active Epstein-Barr infection within ≤ 60 days of study registration

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Study Outline:

This is a multicenter study. Patients are stratified according to disease stage (IIIA vs IIIB or IV), response to prior treatment with front-line chemotherapy (stable disease vs partial response or complete response), prior treatment with front-line chemotherapy and radiotherapy (front-line chemotherapy with radiotherapy vs front-line chemotherapy alone), and prior treatment with front-line chemotherapy and other anticancer therapy (front-line chemotherapy with bevacizumab vs front-line chemotherapy alone or in combination with another anticancer agent). Patients are randomized to one of two treatment arms.

Arm I:
• Patients receive belagenpumatucel-L (Lucanix™) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity

Arm II:
• Patients receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity

• Blood samples are collected periodically and analyzed for cytokines and chemokines and circulating tumor cells, including response to multiple lung cancer-associated antigens by IFN-γ ELISPOT CD8+ assay; CEA by CD4 class II assay; lung tumor-associated antigens by in vitro proliferation assays; regulatory T-cell (Treg) phenotype by flow cytometry; and Treg function
• Patients complete the Lung Cancer Symptom Scale quality of life questionnaire at baseline, on the days of treatment, 30 days after completion of study treatment, and then every 3 months for 1 year
• After completion of study treatment, patients are followed every 3 months for 1 year and then annually for 4 years

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/9/09
Updated: 8/21/09