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. Sigman; Gideon M. Blumenthal; Shakun Malik; Gary J. Kelloff; Jeffrey S. Abrams; Charles D. Blanke; Vassiliki A. Papadimitrakopoulou

doi:10.1158/1078-0432.CCR-13-3473

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

Knight Cancer Institute

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194 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 language	English (US)
Pages (from-to)	1514-1524
Number of pages	11
Journal	Clinical Cancer Research
Volume	21
Issue number	7
DOIs	https://doi.org/10.1158/1078-0432.CCR-13-3473
State	Published - Apr 1 2015

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General Medicine

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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

Herbst, RS, Gandara, DR, Hirsch, FR, Redman, MW, LeBlanc, M, Mack, PC, Schwartz, LH, Vokes, E, Ramalingam, SS, Bradley, JD, Sparks, D, Zhou, Y, Miwa, C, Miller, VA, Yelensky, R, Li, Y, Allen, JD, Sigal, EV, Wholley, D, Sigman, CC, Blumenthal, GM, Malik, S, Kelloff, GJ, Abrams, JS, Blanke, CD & Papadimitrakopoulou, VA 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, vol. 21, no. 7, pp. 1514-1524. https://doi.org/10.1158/1078-0432.CCR-13-3473

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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.",

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doi = "10.1158/1078-0432.CCR-13-3473",

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AU - Hirsch, Fred R.

AU - Redman, Mary W.

AU - LeBlanc, Michael

AU - Mack, Philip C.

AU - Schwartz, Lawrence H.

AU - Vokes, Everett

AU - Ramalingam, Suresh S.

AU - Bradley, Jeffrey D.

AU - Sparks, Dana

AU - Zhou, Yang

AU - Miwa, Crystal

AU - Miller, Vincent A.

AU - Yelensky, Roman

AU - Li, Yali

AU - Allen, Jeff D.

AU - Sigal, Ellen V.

AU - Wholley, David

AU - Sigman, Caroline C.

AU - Blumenthal, Gideon M.

AU - Malik, Shakun

AU - Kelloff, Gary J.

AU - Abrams, Jeffrey S.

AU - Blanke, Charles D.

AU - Papadimitrakopoulou, Vassiliki A.

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

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