drugset / Trial / NCT00157196

Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease

NCT00157196

Phase 2 Completed 22 enrolled Merck KGaA, Darmstadt, Germany
NaSingle-groupOpen-labelTreatment

Summary

The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This population includes Stage IIIA NSCLC subjects, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of subjects treated.

Timeline

Start
2005-04
Primary completion
2007-09
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Tecemotide Vaccine 1000 ug Subcutaneous
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous