Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)
Condition: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: Tecemotide (L-BLP25); Single low dose cyclophosphamide; Best Supportive Care (BSC)
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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