Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)

PHASE2CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

August 31, 2000

Primary Completion Date

March 31, 2006

Study Completion Date

July 31, 2012

Conditions
Lung NeoplasmsCarcinoma, Non-Small-Cell Lung
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 discontinuation from the study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of the investigator, and in case of unavailability of study vaccine.

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 given 3 days before the first vaccine treatment.

OTHER

Best Supportive Care (BSC)

The BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease.

Trial Locations (1)

Unknown

Please Contact the Merck KGaA Communication Center, Darmstadt

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00157209 - Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer) | Biotech Hunter | Biotech Hunter