| Literature DB >> 25680375 |
Roy S Herbst1, David R Gandara2, Fred R Hirsch3, Mary W Redman4, Michael LeBlanc4, Philip C Mack2, Lawrence H Schwartz5, Everett Vokes6, Suresh S Ramalingam7, Jeffrey D Bradley8, Dana Sparks9, Yang Zhou10, Crystal Miwa9, Vincent A Miller11, Roman Yelensky11, Yali Li11, Jeff D Allen12, Ellen V Sigal12, David Wholley13, Caroline C Sigman14, Gideon M Blumenthal15, Shakun Malik16, Gary J Kelloff17, Jeffrey S Abrams18, Charles D Blanke19, Vassiliki A Papadimitrakopoulou20.
Abstract
The Lung Master Protocol (Lung-MAP, S1400) is a groundbreaking clinical trial designed to advance the efficient development of targeted therapies for squamous cell carcinoma (SCC) of the lung. There are no approved targeted therapies specific to advanced lung SCC, although The Cancer Genome Atlas project and similar studies have detected a significant number of somatic gene mutations/amplifications in lung SCC, some of which are targetable by investigational agents. However, the frequency of these changes is low (5%-20%), making recruitment and study conduct challenging in the traditional clinical trial setting. Here, we describe our approach to development of a biomarker-driven phase II/II multisubstudy "Master Protocol," using a common platform (next-generation DNA sequencing) to identify actionable molecular abnormalities, followed by randomization to the relevant targeted therapy versus standard of care. ©2015 American Association for Cancer Research.Entities:
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Year: 2015 PMID： 25680375 PMCID： PMC4654466 DOI： 10.1158/1078-0432.CCR-13-3473
Source DB: PubMed Journal: Clin Cancer Res ISSN： 1078-0432 Impact factor: 12.531