Lung Cancer Clinical Trial
A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. 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
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Pathologically proven stage I-III NSCLC
Confirmed product related ras mutation
ECOG performance status of less than or equal to 2
greater than or equal to 18 years of age
Exclusion Criteria:
History of a previous cancer
History of splenectomy
History of Crohns disease or ulcerative colitis
History of major organ transplantation
Concurrent or chronic steroid therapy
History of allergy to yeast
Presence of an unstable or poorly controlled medical condition
Pregnant or nursing mothers
Positive skin test to yeast
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There is 1 Location for this study
New York New York, 10021, United States
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