A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.
A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.
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)
Inclusion Criteria:
Exclusion Criteria:
Pre-Therapies:
Disease Status:
Physiological Functions:
Standard Safety:
Los Angeles, California 90048, United States
Metarie, Louisiana 70006, United States
Baltimore, Maryland, United States
Chapel Hill, North Carolina 27599, United States
San Antonio, Texas 78229, United States
Capital, Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Argentina
Inssbruck, Austria
Wein, Venna, Austria
Porto Alegre, Rio Grande Do Sol, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Algre, Rio Grande do Sul, Brazil
Ondina-Salvdor, Brazil
Rio de Janeriro, Brazil
Saint Catharines, Ontario, Canada
Thunder Bay, Ontario, Canada
Ostrava-Poruba, Czechia
Nantes-Saint Herblain, France
Tatabayana, Hungary
Avelino, Italy
Orbassano-Torino, Italy
Rozzano-Milano, Italy
Hoofdrop, Netherlands
Santa Maria de Feira, Portugal
Chelaybinsk, Russia
Seoul, Gyeonggi-do, South Korea
Cornwall, United Kingdom
Surrey, United Kingdom