title: INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer.
abstract: BACKGROUND
  Previous research suggests the therapeutic cancer vaccine L-BLP25 potentially provides a survival benefit in patients with locally advanced unresectable stage III non-small cell lung carcinoma (NSCLC). These promising findings prompted the phase III study, INSPIRE, in patients of East-Asian ethnicity. East-Asian ethnicity is an independent favourable prognostic factor for survival in NSCLC. The favourable prognosis is most likely due to a higher incidence of EGFR mutations among this patient population.
  
  
  METHODS
  The primary objective of the INSPIRE study is to assess the treatment effect of L-BLP25 plus best supportive care (BSC), as compared to placebo plus BSC, on overall survival time in East-Asian patients with unresectable stage III NSCLC and either documented stable disease or an objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria following primary chemoradiotherapy. Those in the L-BLP25 arm will receive a single intravenous infusion of cyclophosphamide (300 mg/m2) 3 days before the first L-BLP25 vaccination, with a corresponding intravenous infusion of saline to be given in the control arm. A primary treatment phase of 8 subcutaneous vaccinations of L-BLP25 930 μg or placebo at weekly intervals will be followed by a maintenance treatment phase of 6-weekly vaccinations continued until disease progression or discontinuation from the study.
  
  
  CONCLUSIONS
  The ongoing INSPIRE study is the first large study of a therapeutic cancer vaccine specifically in an East-Asian population. It evaluates the potential of maintenance therapy with L-BLP25 to prolong survival in East-Asian patients with stage III NSCLC where there are limited treatment options currently available. STUDY NUMBER: EMR 63325-012
  
  
  BACKGROUND
  Clinicaltrials.gov reference: NCT01015443.
authors: Guangdong General Hospital & Guangdong Academy of Medical Sciences,Guangzhou, China.
authors: Yi-Long
authors: YL
authors: Wu
authors: Keunchil
authors: K
authors: Park
authors: Ross A
authors: RA
authors: Soo
authors: Yan
authors: Y
authors: Sun
authors: Karin
authors: K
authors: Tyroller
authors: David
authors: D
authors: Wages
authors: Guy
authors: G
authors: Ely
authors: James Chih-Hsin
authors: JC
authors: Yang
authors: Tony
authors: T
authors: Mok
mesh_terms: D044466:Asian People; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008562:Membrane Glycoproteins / Q000627:therapeutic use*; D009367:Neoplasm Staging; D012107:Research Design
chemical_list: D019496:Cancer Vaccines; C518273:L-BLP25; D008562:Membrane Glycoproteins