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

About this trial
This is an interventional treatment trial for Lung Neoplasms
Eligibility Criteria
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
Sites / Locations
- Please Contact the Merck KGaA Communication Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Tecemotide (L-BLP25) plus Best Supportive Care (BSC)
Best Supportive Care (BSC) Alone