NCT02049151

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of Tecemotide Versus Placebo in Subjects With Completed Concurrent Chemo-radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Tecemotide	Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.
DRUG	Placebo	Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.
DRUG	Cyclophosphamide (CPA)	CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m\^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide.
DRUG	Saline (sodium chloride)	Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent \[%\] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-01-30
• Last updated: 2017-08-23
• Results posted: 2017-03-30

Locations

2 sites across 2 countries: United States, Germany