drugset / Trial / NCT00455572

Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer

NCT00455572

Phase 1 Terminated 71 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start
2007-05-11
Primary completion
2013-08-04
Completion
2013-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK1572932A Protein / enzyme biologic 300 ug Intramuscular
Background Cisplatin Other / unclassified Intravenous
Background Vinorelbine Small molecule Intravenous