A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation
NSCLC is the deadliest form of human cancer, killing approximately 150,000 people a year in
the United States. The best treatment for NSCLC is surgical resection. For patients with
inoperable or unresectable NSCLC chemotherapy and radiation is used as first line therapy.
This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with
curative intent who are disease free at their first post-treatment restaging assessment.
These subjects must also have a ras mutation.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Immune response to GI-4000
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|