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

A Multicenter Phase IIb Randomised, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer

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.

Inclusion Criteria:

• Stage IIIB or Stage IV NSCLC
• Stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. Subjects must have completed the first-line treatment at least 3 weeks prior to study entry
• Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (>=) 2
• Ability to understand and willingness to sign a written informed consent
• Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

• Received immunotherapy within 4 weeks prior to study entry
• Received immunosuppressive drugs within 3 weeks prior to study entry
• Subjects with known brain metastases
• Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
• Autoimmune disease or immunodeficiency
• Clinically significant hepatic, renal or cardiac dysfunction
• Subjects with clinically significant active infection
• Pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
• Other protocol-defined exclusion criteria could apply