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

PHASE3TerminatedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
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.

Trial Locations (2)

Unknown

Please Contact U.S. Medical Information Located in, Rockland

Please contact the Merck KGaA Communication Center Located in, Darmstadt

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT02049151 - Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer | Biotech Hunter | Biotech Hunter