Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
This is a prospective open label, controlled, randomized study to test the safety and
efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of
subjects with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC). To be eligible,
subjects entering the trial will have to demonstrate either stable disease or a clinical
response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy)
and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Following a 3 week washout period, subjects will be stratified by disease status (either
Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV),
and randomized to either best supportive care (BSC) plus tecemotide (L-BLP25) treatment or
BSC alone.