cancer vaccine study for unresectable stage iii non-small cell lung cancer (start)

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine whether the cancer vaccine tecemotide (l-blp25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage iii non-small cell lung cancer, compared to best supportive care alone. a local ancillary (sub) study in european centers will evaluate the immune response in peripheral blood after tecemotide (l-blp25) or placebo vaccination.

ancillary trial: an exploratory investigation of immune response in peripheral blood after tecemotide (l-blp25) or placebo vaccination. the ancillary study is a sub-study within start. this is an exploratory investigation of the immune response in peripheral blood after tecemotide (l-blp25) or placebo vaccination. the main objective is to evaluate whether administration of single-shot, low-dose cyclophosphamide followed by tecemotide (l-blp25) vaccinations induces specific immune response in peripheral blood to blp25 (the mucinous glycoprotein 1 \[muc1\] antigen) as well as a modulation of cellular and soluble components of the immune response in subjects with unresectable stage iii nsclc. twenty-five of the european start sites will participate in the ancillary study. sample size: up to 60 to 80 subjects all inclusion criteria specified in the start clinical trial protocol except for hemoglobin \>= 100 gram/liter (g/l) all exclusion criteria are the same as specified in the start clinical trial protocol schedule of events: blood samples will be taken at baseline, visit week 4, 8 13 and 25 (80 milliliter (ml) whole blood each)

Eligibility criteria:
inclusion criteria: * histologically or cytologically documented unresectable stage iii non-small cell lung cancer (nsclc) * documented stable disease or objective response, according to response evaluation criteria in solid tumors (recist), after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage iii disease, within 4 weeks (28 days) prior to randomization * receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of \>=50 gray (gy). subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible * geographically accessible for ongoing follow-up, and committed to comply with the designated visits * an eastern cooperative oncology group (ecog) performance status of 0-1 * a platelet count \> 140 x 10\^9/liter; white blood cells (wbc) \> 2.5 x 10\^9/liter and hemoglobin \> 90 gram per liter (g/l) exclusion criteria: pre-therapies: * undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy * receipt of immunotherapy (e.g. interferons, tumor necrosis factor \[tnf\], interleukins, or biological response modifiers \[granulocyte macrophage colony stimulating factor {gm-csf}, granulocyte colony stimulating factor {g-csf}, macrophage-colony stimulating factor {m-csf}\], monoclonal antibodies) within 4 weeks (28 days) prior to randomization * receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization disease status: * metastatic disease * malignant pleural effusion at initial diagnosis and/or at study entry * 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 * a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies * any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed) * known hepatitis b and/or c physiological functions: * clinically significant hepatic dysfunction * clinically significant renal dysfunction * clinically significant cardiac disease * splenectomy * infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response standard safety: * pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator * known drug abuse/alcohol abuse * legal incapacity or limited legal capacity

Keywords: non-small cell lung carcinoma; stage iii; unresectable; vaccine; tecemotide; l-blp25; cyclophosphamide; placebo controlled; randomized; double blind; immunotherapy;