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)

Dataset Linkage

Links to additional datasets associated with this dataset are shown below.

• 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