NCT00157196

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

A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-09-01
• Completion: 2012-04-01
• First posted: 2005-09-12
• Last updated: 2015-08-18
• Results posted: 2015-08-18