The purpose of this study is to evaluate the clinical efficacy of an investigational agent,
P10s-PADRE, a peptide mimotope-based vaccine, in patients of all races with stage IV
Non-Small Cell Lung Cancer who have completed their primary chemotherapy without
progressing, and who still have measurable residual disease.
A randomized double-blind placebo-controlled trial is designed with the goal being to
evaluate the efficacy of the vaccine. Efficacy will be based primarily on the tumor
response, and secondarily on progression-free survival. Information on safety and
tolerability will be collected. Humoral and cellular immune responses will be analyzed.
- stage IV Non-Small Cell Lung Cancer
- completed their primary chemotherapy
- achieved either stable disease or partial response with measurable residual disease
- Women who are pregnant or breast-feeding.
- Patients who have autoimmune disease or are immunosuppressed or receiving systemic