Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400

• Type of Material: Article
• Authors: Roy S. Herbst, Yale University; David R. Gandara, University of California Davis; Fred R. Hirsch, University of Colorado; Mary W. Redman, Fred Hutchinson Cancer Research Center; Michael LeBlanc, Fred Hutchinson Cancer Research Center; Philip C. Mack, University of California Davis; Lawrence H. Schwartz, Columbia University; Everett Vokes, University of Chicago; Suresh Ramalingam, Emory University; Jeffrey D. Bradley, Washington University in St. Louis; Dana Sparks, SWOG; Yang Zhou, Yale University; Crystal Miwa, SWOG; Vincent A. Miller, Foundation Medicine; Roman Yelensky, Foundation Medicine; Yali Li, Foundation Medicine; Jeff D. Allen, Friends of Cancer Research; Ellen V. Sigal, Friends of Cancer Research; David Wholley, Foundation for the National Institutes of Health; Caroline C. Sigman, CCS Associates; Gideon M. Blumenthal, US Food & Drug Administration; Shakun Malik, National Cancer Institute; Gary J. Kelloff, National Cancer Institute; Jeffrey S. Abrams, National Cancer Institute; Charles D. Blanke, SWOG; Vassiliki A. Papadimitrakopoulou, MD Anderson Cancer Center
• Language: English
• Date: 2015-04-01
• Publisher: American Association for Cancer Research
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: ©2015 American Association for Cancer Research.
• Final Published Version (URL): http://dx.doi.org/10.1158/1078-0432.CCR-13-3473
• Title of Journal or Parent Work: Clinical Cancer Research
• ISSN: 1078-0432
• Volume: 21
• Issue: 7
• Start Page: 1514
• End Page: 1524
• Grant/Funding Information: This work was supported in part by the NCI of the NIH under award numbers U10CA180888 (to SWOG), U10CA180819 (to SWOG), and R01CA155196 (to R.S. Herbst) and by Amgen, AstraZeneca, Genentech, and Pfizer, through the Foundation for the National Institutes of Health and in partnership with Friends of Cancer Research.
• Keywords: Life Sciences & Biomedicine; DESIGN; BREAST-CANCER; ALECTINIB; Oncology; AZD4547; ANTITUMOR-ACTIVITY; IN-VIVO; ONCOLOGY; CLINICAL-TRIALS; Science & Technology; GENOMICS; SELECTIVE INHIBITOR
• Research Categories: Health Sciences, Oncology; Health Sciences, Pharmacology

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.