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Clin Cancer Res. 2015 Apr 1;21(7):1514-24. doi: 10.1158/1078-0432.CCR-13-3473. Epub 2015 Feb 13.

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

Author information

1
Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut. roy.herbst@yale.edu.
2
University of California Davis Cancer Center, Sacramento, California.
3
Department of Medical Oncology, University of Colorado Health Sciences Center, Aurora, Colorado.
4
SWOG Statistical Center; Fred Hutchinson Cancer Research Center, Seattle, Washington.
5
Department of Radiology, Columbia University Medical College, New York, New York.
6
Department of Medicine, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois.
7
Department of Hematology and Medical Oncology, Emory University, Atlanta, Georgia.
8
Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri.
9
SWOG Operations Office, San Antonio, Texas.
10
Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.
11
Foundation Medicine, Cambridge, Massachusetts.
12
Friends of Cancer Research, Washington, District of Columbia.
13
Foundation for the National Institutes of Health, Bethesda, Maryland.
14
CCS Associates, Mountain View, California.
15
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
16
Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.
17
Cancer Imaging Program, National Cancer Institute, Bethesda, Maryland.
18
Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.
19
SWOG Group Chair's Office; Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.
20
University of Texas MD Anderson Cancer Center, Houston, Texas.

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.

PMID:
25680375
PMCID:
PMC4654466
DOI:
10.1158/1078-0432.CCR-13-3473
[Indexed for MEDLINE]
Free PMC Article

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