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

Phase 2 Completed 24 enrolled GlobeImmune Memorial Sloan Kettering Cancer Center · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2008-04
Primary completion: 2013-11
Completion: 2013-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GI-4000	Vaccine	40 unknown	Subcutaneous

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

Timeline

Drugs

Indications