TY - JOUR
T1 - Lung Master Protocol (Lung-MAP) - A biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer
T2 - SWOG S1400
AU - Herbst, Roy S.
AU - Gandara, David R.
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.
N1 - Publisher Copyright:
©2015 American Association for Cancer Research.
PY - 2015/4/1
Y1 - 2015/4/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84927606243&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-13-3473
DO - 10.1158/1078-0432.CCR-13-3473
M3 - Article
C2 - 25680375
AN - SCOPUS:84927606243
SN - 1078-0432
VL - 21
SP - 1514
EP - 1524
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 7
ER -