drugset / Trial / NCT02049151

Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer

NCT02049151

Phase 3 Terminated 35 enrolled EMD Serono
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.

Timeline

Start
2014-03
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tecemotide Vaccine 806 ug Subcutaneous
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous