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

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

September 30, 2007

Study Completion Date

April 30, 2012

Conditions
Carcinoma, Non-Small-Cell LungLung Neoplasms
Interventions
BIOLOGICAL

Tecemotide (L-BLP25)

After receiving single low-dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide \[L-BLP25\]) at 6-week intervals, commencing at Week 13, until disease progression is documented.

DRUG

Single low dose cyclophosphamide

A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.

OTHER

Best standard of care (BSC)

The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00157196 - Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease | Biotech Hunter | Biotech Hunter