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Protocol Number: 08-C-0075 
The MAGE-3 vaccine is made from a protein (MAGE-3) found in the tumors of some people with non-small-cell lung cancer (NSCLC). It is designed to stimulate an immune response directing the body to destroy cells that have the protein. Objectives: To determine if the MAGE-3 vaccine can prevent a recurrence of cancer in patients with NSCLC whose tumor has the MAGE-3 protein.
Eligibility: Patients with NSCLC whose tumor expresses the MAGE-3 and who have undergone surgical treatment with or without chemotherapy. Design: Vaccine/placebo injections: Patients are randomly assigned to receive injections of either the vaccine MAGE-3 vaccine or placebo (fluid with no active ingredient). The first five injections are given once every 3 weeks; the next eight injections are given every 3 months. At each injection visit, subjects have a physical examination and a review of symptoms, medications, and any hospital admissions since the last injection. Imaging tests: Subjects have a CT scan and chest x-ray to check that all the cancer has been removed during surgery; a brain CT or MRI scan to check that the cancer has not spread to the brain; and CT scans and chest x-rays every 6 months to monitor for cancer recurrence. Other examinations may be done as required. Blood tests are done at study months 12, 24 and 30 for routine laboratory evaluations and at study day 1, weeks 6 and 12 and months 9, 12, 18, 24 and 30 to evaluate the immune response to the injections. Follow-up visits: For 5 years after receiving the last injection, subjects return the hospital every 6 months for a clinic visit. Each visit includes a physical examination, review of symptoms and any hospital admissions and either a CT scan or a chest x-ray to look for recurrence of the tumor. Phone follow-up: After 5 years, participants are contacted by phone yearly for another 5 years to follow their progress.
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National Institutes of Health Clinical Center