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Open Access Highly Accessed Study protocol

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

Yi-Long Wu1, Keunchil Park2, Ross A Soo3, Yan Sun4, Karin Tyroller5, David Wages6, Guy Ely, James Chih-Hsin Yang7 and Tony Mok8*

Author Affiliations

1 Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China

2 Samsung Medical Center, 50, Irwon-Dong, Gangnam-gu, Seoul, 135-710 Korea

3 National University Cancer Institute Singapore (NCIS), National University Hospital, Singapore; Cancer Science Institute of Singapore, National University of Singapore, Singapore

4 Cancer Hospital and Institute Chinese Academy of Medical Sciences, China

5 Merck KGaA, Darmstadt, Germany

6 EMD Serono, Rockland, USA

7 National Taiwan University Hospital Department of Oncology, 4404 Room, 4F, No.1 Chang De St, 100 Taipei, Taiwan

8 State Key Laboratory of Southern China, The Chinese University of Hong Kong, Sir YK Pau Cancer Center, Prince of Wales Hospital, Hong Kong, China

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BMC Cancer 2011, 11:430  doi:10.1186/1471-2407-11-430

Published: 7 October 2011

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/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/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.

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