title: Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400.
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.
authors: Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut. roy.herbst@yale.edu.
authors: Roy S
authors: RS
authors: Herbst
authors: University of California Davis Cancer Center, Sacramento, California.
authors: David R
authors: DR
authors: Gandara
authors: Department of Medical Oncology, University of Colorado Health Sciences Center, Aurora, Colorado.
authors: Fred R
authors: FR
authors: Hirsch
authors: SWOG Statistical Center; Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Mary W
authors: MW
authors: Redman
authors: SWOG Statistical Center; Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Michael
authors: M
authors: LeBlanc
authors: University of California Davis Cancer Center, Sacramento, California.
authors: Philip C
authors: PC
authors: Mack
authors: Department of Radiology, Columbia University Medical College, New York, New York.
authors: Lawrence H
authors: LH
authors: Schwartz
authors: Department of Medicine, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois.
authors: Everett
authors: E
authors: Vokes
authors: Department of Hematology and Medical Oncology, Emory University, Atlanta, Georgia.
authors: Suresh S
authors: SS
authors: Ramalingam
authors: Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri.
authors: Jeffrey D
authors: JD
authors: Bradley
authors: SWOG Operations Office, San Antonio, Texas.
authors: Dana
authors: D
authors: Sparks
authors: Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.
authors: Yang
authors: Y
authors: Zhou
authors: SWOG Operations Office, San Antonio, Texas.
authors: Crystal
authors: C
authors: Miwa
authors: Foundation Medicine, Cambridge, Massachusetts.
authors: Vincent A
authors: VA
authors: Miller
authors: Foundation Medicine, Cambridge, Massachusetts.
authors: Roman
authors: R
authors: Yelensky
authors: Foundation Medicine, Cambridge, Massachusetts.
authors: Yali
authors: Y
authors: Li
authors: Friends of Cancer Research, Washington, District of Columbia.
authors: Jeff D
authors: JD
authors: Allen
authors: Friends of Cancer Research, Washington, District of Columbia.
authors: Ellen V
authors: EV
authors: Sigal
authors: Foundation for the National Institutes of Health, Bethesda, Maryland.
authors: David
authors: D
authors: Wholley
authors: CCS Associates, Mountain View, California.
authors: Caroline C
authors: CC
authors: Sigman
authors: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
authors: Gideon M
authors: GM
authors: Blumenthal
authors: Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.
authors: Shakun
authors: S
authors: Malik
authors: Cancer Imaging Program, National Cancer Institute, Bethesda, Maryland.
authors: Gary J
authors: GJ
authors: Kelloff
authors: Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.
authors: Jeffrey S
authors: JS
authors: Abrams
authors: SWOG Group Chair's Office; Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.
authors: Charles D
authors: CD
authors: Blanke
authors: University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Vassiliki A
authors: VA
authors: Papadimitrakopoulou
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000235:genetics*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000235:genetics; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics; D057285:Precision Medicine / Q000379:methods*; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor