Cargando…

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

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-As...

Descripción completa

Detalles Bibliográficos
Autores principales: Wu, Yi-Long, Park, Keunchil, Soo, Ross A, Sun, Yan, Tyroller, Karin, Wages, David, Ely, Guy, Yang, James Chih-Hsin, Mok, Tony
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3203100/
https://www.ncbi.nlm.nih.gov/pubmed/21982342
http://dx.doi.org/10.1186/1471-2407-11-430
_version_ 1782215071889358848
author Wu, Yi-Long
Park, Keunchil
Soo, Ross A
Sun, Yan
Tyroller, Karin
Wages, David
Ely, Guy
Yang, James Chih-Hsin
Mok, Tony
author_facet Wu, Yi-Long
Park, Keunchil
Soo, Ross A
Sun, Yan
Tyroller, Karin
Wages, David
Ely, Guy
Yang, James Chih-Hsin
Mok, Tony
author_sort Wu, Yi-Long
collection PubMed
description 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/DESIGN: 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/m(2)) 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. DISCUSSION: 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 TRIAL REGISTRATION: Clinicaltrials.gov reference: NCT01015443
format Online
Article
Text
id pubmed-3203100
institution National Center for Biotechnology Information
language English
publishDate 2011
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-32031002011-10-28 INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer Wu, Yi-Long Park, Keunchil Soo, Ross A Sun, Yan Tyroller, Karin Wages, David Ely, Guy Yang, James Chih-Hsin Mok, Tony BMC Cancer Study Protocol 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/DESIGN: 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/m(2)) 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. DISCUSSION: 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 TRIAL REGISTRATION: Clinicaltrials.gov reference: NCT01015443 BioMed Central 2011-10-07 /pmc/articles/PMC3203100/ /pubmed/21982342 http://dx.doi.org/10.1186/1471-2407-11-430 Text en Copyright ©2011 Wu et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Wu, Yi-Long
Park, Keunchil
Soo, Ross A
Sun, Yan
Tyroller, Karin
Wages, David
Ely, Guy
Yang, James Chih-Hsin
Mok, Tony
INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer
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
title_full INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer
title_fullStr INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer
title_full_unstemmed INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer
title_short INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer
title_sort inspire: a phase iii study of the blp25 liposome vaccine (l-blp25) in asian patients with unresectable stage iii non-small cell lung cancer
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3203100/
https://www.ncbi.nlm.nih.gov/pubmed/21982342
http://dx.doi.org/10.1186/1471-2407-11-430
work_keys_str_mv AT wuyilong inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer
AT parkkeunchil inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer
AT soorossa inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer
AT sunyan inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer
AT tyrollerkarin inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer
AT wagesdavid inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer
AT elyguy inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer
AT yangjameschihhsin inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer
AT moktony inspireaphaseiiistudyoftheblp25liposomevaccinelblp25inasianpatientswithunresectablestageiiinonsmallcelllungcancer