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

被引：181

作者：

Herbst, Roy S. ^{[1
]}

Gandara, David R. ^{[2
]}

Hirsch, Fred R. ^{[3
]}

Redman, Mary W. ^{[4
,5
]}

LeBlanc, Michael ^{[4
,5
]}

Mack, Philip C. ^{[2
]}

Schwartz, Lawrence H. ^{[6
]}

Vokes, Everett ^{[7
]}

Ramalingam, Suresh S. ^{[8
]}

Bradley, Jeffrey D. ^{[9
]}

Sparks, Dana ^{[10
]}

Zhou, Yang ^{[1
]}

Miwa, Crystal ^{[10
]}

Miller, Vincent A. ^{[11
]}

Yelensky, Roman ^{[11
]}

Li, Yali ^{[11
]}

Allen, Jeff D. ^{[12
]}

Sigal, Ellen V. ^{[12
]}

Wholley, David ^{[13
]}

Sigman, Caroline C. ^{[14
]}

Blumenthal, Gideon M. ^{[15
]}

Malik, Shakun ^{[16
]}

Kelloff, Gary J. ^{[17
]}

Abrams, Jeffrey S. ^{[18
]}

Blanke, Charles D. ^{[19
,20
]}

Papadimitrakopoulou, Vassiliki A. ^{[21
]}

机构：

[1] Yale Univ, Sch Med, Yale Canc Ctr, New Haven, CT 06520 USA

[2] Univ Calif Davis, Ctr Canc, Sacramento, CA 95817 USA

[3] Univ Colorado, Dept Med Oncol, Hlth Sci Ctr, Aurora, CO USA

[4] SWOG Stat Ctr, Seattle, WA USA

[5] Fred Hutchinson Canc Res Ctr, Seattle, WA 98104 USA

[6] Columbia Univ, Dept Radiol, Coll Med, New York, NY USA

[7] Univ Chicago Med & Biol Sci, Dept Med, Chicago, IL USA

[8] Emory Univ, Dept Hematol & Med Oncol, Atlanta, GA 30322 USA

[9] Washington Univ, Sch Med, Dept Radiat Oncol, St Louis, MO USA

[10] SWOG Operat Off, San Antonio, TX USA

[11] Fdn Med, Cambridge, MA USA

[12] Friends Canc Res, Washington, DC USA

[13] Fdn Natl Inst Hlth, Bethesda, MD USA

[14] CCS Associates, Mountain View, CA USA

[15] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[16] NCI, Ctr Canc Res, Bethesda, MD 20892 USA

[17] NCI, Canc Imaging Program, Bethesda, MD 20892 USA

[18] NCI, Canc Therapy Evaluat Program, Bethesda, MD 20892 USA

[19] SWOG Grp Chairs Office, Portland, OR USA

[20] Oregon Hlth & Sci Univ, Knight Canc Inst, Portland, OR 97201 USA

[21] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

来源：

CLINICAL CANCER RESEARCH | 2015年 / 21卷 / 07期

基金：

美国国家卫生研究院;

关键词：

SELECTIVE INHIBITOR; CLINICAL-TRIALS; ONCOLOGY; PALBOCICLIB; ALECTINIB; GENOMICS; AZD4547; TARGETS; POTENT; BAR;

D O I：

10.1158/1078-0432.CCR-13-3473

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The Lung Master Protocol (Lung-MAP, S1400) is a ground-breaking 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. (C) 2015 AACR.

引用

页码：1514 / 1524

页数：11

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