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Lung (Non-Small Cell)

START - Stimulating Targeted Antigenic Responses To NSCLC. A multi-center phase III randomized, double-blind placebocontrolled 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

Unique Data Set IDLungNo_MerckKG_2007_145
DownloadableYes
SponsorMerck KGaAData ProviderEMD SeronoTotal Study Enrolled Patients1513Comparator (Control) Arm Enrolled Patients507RandomizationYesClinicalTrial.gov IDNCT00409188ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/record/NCT00409188
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypePlaceboData Set TypeOther

Clinical Trial Title

START - Stimulating Targeted Antigenic Responses To NSCLC. A multi-center phase III randomized, double-blind placebocontrolled 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

Trial Summary and Conditions

A multi-center phase III randomized, double-blind placebo-controlled study in subjects with unresectable stage III NSCLC who have demonstrated either stable disease or objective response following primary chemo-radiotherapy (concomitant or sequential). Subjects will be randomized 2:1 either to L-BLP25 drug product (hereinafter "L-BLP25") (investigational arm) or to L-BLP25 placebo (hereinafter "placebo"), respectively. Subjects were stratified by Disease stage (IIIA versus IIIB), Response to primary chemo-radiotherapy (stable disease versus objective response), Type of primary chemo-radiotherapy (concomitant versus sequential) and Region (1: North America and Australia, 2: Western Europe, or 3: Rest of World).

Data Summary

Control arm data files include medical history, eligibility, demography, efficacy, safety, concomitant medications, quality of life and laboratory assessment

Study Objectives

Primary 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).

Outcome Measures

Overall Survival, Time to symptom progression (TTSP) as measured by the Lung Cancer Symptom Scale (LCSS), Time to progression (TTP) as determined by the investigator, Progression free survival (PFS), QoL index (EQ-5D), Additional QoL analyses utilizing the LCSS, Time to treatment failure (TTF), Adverse Events (AEs)

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: EMR63325-001_start_v07_Redacted Clinical Study Protocol.pdf

CRF: EMR63325-001_START_SAS annotated eCRF_.pdf.pdf

DATA DICTIONARY: Data Dictionary.pdf

DATA (COMPARATOR ARM): emr63325-001_START_Raw Data.zip