Lung Master Protocol (Lung-MAP) - A biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400

Roy S. Herbst, David R. Gandara, Fred R. Hirsch, Mary W. Redman, Michael LeBlanc, Philip C. Mack, Lawrence H. Schwartz, Everett Vokes, Suresh S. Ramalingam, Jeffrey D. Bradley, Dana Sparks, Yang Zhou, Crystal Miwa, Vincent A. Miller, Roman Yelensky, Yali Li, Jeff D. Allen, Ellen V. Sigal, David Wholley, Caroline C. SigmanGideon M. Blumenthal, Shakun Malik, Gary J. Kelloff, Jeffrey S. Abrams, Charles D. Blanke, Vassiliki A. Papadimitrakopoulou

Research output: Contribution to journalArticle

136 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1514-1524
Number of pages11
JournalClinical Cancer Research
Volume21
Issue number7
DOIs
StatePublished - Apr 1 2015

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Herbst, R. S., Gandara, D. R., Hirsch, F. R., Redman, M. W., LeBlanc, M., Mack, P. C., Schwartz, L. H., Vokes, E., Ramalingam, S. S., Bradley, J. D., Sparks, D., Zhou, Y., Miwa, C., Miller, V. A., Yelensky, R., Li, Y., Allen, J. D., Sigal, E. V., Wholley, D., ... Papadimitrakopoulou, V. A. (2015). Lung Master Protocol (Lung-MAP) - A biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400. Clinical Cancer Research, 21(7), 1514-1524. https://doi.org/10.1158/1078-0432.CCR-13-3473