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

Overview

Journal Clin Cancer Res

Specialty Oncology

Date 2015 Feb 15

PMID 25680375

Citations 105

Authors

Roy S Herbst

David R Gandara

Fred R Hirsch

Mary W Redman

Michael LeBlanc

Philip C Mack

Lawrence H Schwartz

Everett Vokes

Suresh S Ramalingam

Jeffrey D Bradley

Dana Sparks

Yang Zhou

Crystal Miwa

Vincent A Miller

Roman Yelensky

Yali Li

Jeff D Allen

Ellen V Sigal

David Wholley

Caroline C Sigman

Gideon M Blumenthal

Shakun Malik

Gary J Kelloff

Jeffrey S Abrams

Charles D Blanke

Vassiliki A Papadimitrakopoulou

Affiliations

Soon will be listed here.

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.

Citing Articles

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