Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400.
Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400.
复制标题
DOI：
10.1158/1078-0432.ccr-13-3473
复制
发表时间：
2015-04-01
期刊：
影响因子：
--
通讯作者：
Papadimitrakopoulou VA
中科院分区：
文献类型：
--
作者：
Herbst RS;Gandara DR;Hirsch FR;Redman MW;LeBlanc M;Mack PC;Schwartz LH;Vokes E;Ramalingam SS;Bradley JD;Sparks D;Zhou Y;Miwa C;Miller VA;Yelensky R;Li Y;Allen JD;Sigal EV;Wholley D;Sigman CC;Blumenthal GM;Malik S;Kelloff GJ;Abrams JS;Blanke CD;Papadimitrakopoulou VA
肺主协议(LONG-MAP，S1400)是一项突破性的临床试验，旨在促进肺鳞状细胞癌(SCCA)靶向治疗的有效开发。尽管癌症基因组图谱(TCGA)项目和类似的研究在肺SCCA中发现了大量的体细胞基因突变/扩增，其中一些是研究药物的靶向，但目前还没有针对晚期肺SCCA的靶向治疗。然而，这些变化的频率很低(5%-20%)，这使得招募和研究在传统的临床试验环境中具有挑战性。在这里，我们描述了我们开发生物标记物驱动的2/3期多子研究“主方案”的方法，使用一个通用平台(下一代DNA测序)来识别可操作的分子异常，然后随机进行相关的靶向治疗和护理标准。
The Lung Master Protocol (Lung-MAP, S1400) is a groundbreaking clinical trial designed to advance the efficient development of targeted therapies for squamous cell cancer (SCCA) of the lung. There are no approved targeted therapies specific to advanced lung SCCA, although The Cancer Genome Atlas (TCGA) project and similar studies have detected a significant number of somatic gene mutations/amplifications in lung SCCA, 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 2/3 multi-substudy “Master Protocol,” employing a common platform (Next Generation DNA Sequencing) to identify actionable molecular abnormalities, followed by randomization to the relevant targeted therapy versus standard of care.