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Investigator(s):
David S. Schrump, M.D. Principal Investigator Phone: 301-496-2128 Fax: 301-451-6934 David_Schrump@nih.gov
Referral Contact(s):
Tricia Kunst, R.N. Research Nurse Phone: 301-451-1233 Fax: 301-451-6933 tricia_kunst@nih.gov	Ana Hancox, R.N. Research Nurse Phone: 301-451-1233 Fax: 301-451-6933 ana_hancox@nih.gov

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Primary Eligibility:

• Non-small cell lung cancer pathologically proven stage IB, II, or IIIA
• Completely resected with no evidence of disease
• Tumor shows expression of MAGE-A3 gene
• The surgical technique for resection of the tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy
• No metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain
• The mediastinal lymph node sampling is done according to study protocol guidelines
• ≥ 18 years of age
• ECOG ≤ 2
• Adequate bone-marrow reserve, adequate renal function, and adequate hepatic function as assessed by standard laboratory criteria
• No uncontrolled bleeding disorder
• No uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction), or uncontrolled arrhythmia
• No previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for 5 years or more
• No autoimmune disease such as multiple sclerosis, lupus, inflammatory bowel disease, or HIV-positivity
• No concomitant treatment with systemic corticosteroids or any immunosuppressive agents
• No home oxygen dependence

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Study Outline:

This is a multicenter study. Participants are randomized to receive the MAGE-A3 vaccine or a placebo.

Arm I:

• Patients receive recombinant MAGE-A3 vaccine and SB-AS15 intramuscularly (IM) every 3 weeks for 5 doses and then every 3 months for 8 doses (total of 13 doses)

Arm II:

• Patients receive placebo IM every 3 weeks for 5 doses and then every 3 months for 8 doses (total of 13 doses)

After completion of study treatment, patients are followed every 6 months for a maximum of 5 years after initial injection and then annually for 5 years via telephone contact from a general practitioner until 10 years after the first injection.

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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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/3/09
Updated: 11/5/09