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Table 2 Study objectives

From: INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer

Primary objective

To assess the treatment effect of L-BLP25 plus BSC, as compared to BSC alone, on overall survival time

Secondary objectives

Time to symptom progression (based on LCSS questionnaire)

 

Time to progression

 

Progression-free survival time

 

Time to treatment failure

 

Safety

Other objectives

Quality-of-life (EQ-5D/LCSS)

 

Healthcare resource utilization and work status

 

Biomarkers/pharmacogenetics

  1. BSC: best supportive care; EQ-5D: EuroQol Group 5-Dimension questionnaire; LCSS: Lung Cancer Symptom Scale.