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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
April 2012
NCT00409188Uploaded 10-21-2015
Available for Download
PDS UID: LungNo_MerckKG_2007_145
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.
PDS UID: LungNo_Multipl_2018_231Go to Study
Enhancing the Analytic Capacity of LungNo_MerckKG_2007_145 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionPrimary objective: To compare survival duration of all randomized subjects in the primary analysis population by treatment arm. Secondary objectives of this trial are to compare all randomized subjects in the primary analysis population by treatment arm for: Time to symptom progression (TTSP) as measured by the Lung Cancer Symptom Scale (LCSS); Time to progression (TTP) as determined by the investigator; One-, two- and three-year survival and Safety. Other assessments include Progression free survival (PFS), QoL index (EQ-5D), ? Healthcare resource utilization and work status, Additional QoL analyses utilizing the LCSS, Time to treatment failure (TTF).
SponsorMerck KGaA
Data ProviderEMD Serono
Partial set or SubsetOriginal Data
Patients in dataset1513
# of Patients Control507
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/qr3r-sr08
CDISC StandardSAS Raw Datasets
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsNon-small Cell Lung Cancer
Intervention TypeBiological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Drug: Placebo
Drug(s)Drug: Single low dose cyclophosphamide
Drug: Placebo
Total Enrolled1513
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionTecemotide (L-BLP25) - Experimental
Placebo - Placebo Comparator
Secondary IDN/A
PubMed (PMID)24331154
24976972
34870327
25722382
Collaborator(s)Merck KGaA, Darmstadt, Germany
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Romania
Russian Federation
Singapore
Slovakia
Spain
Sweden
Switzerland
Taiwan
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLEMR63325-001_start_v07_Redacted Clinical Study Protocol.pdf
CRFEMR63325-001_START_SAS annotated eCRF_.pdf.pdf
DATA DICTIONARYData Dictionary.pdf
DATA (COMPARATOR ARM)emr63325-001_START_Raw Data.zip
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