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Lung-MAP—framework, overview, and design principles

  
@article{CCO7845,
	author = {Renata Ferrarotto and Mary W. Redman and David R. Gandara and Roy S. Herbst and Vassiliki A. Papadimitrakopoulou},
	title = {Lung-MAP—framework, overview, and design principles},
	journal = {Chinese Clinical Oncology},
	volume = {4},
	number = {3},
	year = {2015},
	keywords = {},
	abstract = {Metastatic lung squamous cell carcinoma (SCC) is a common disease with limited therapeutic options and poor patient outcomes. Standard “all comers” clinical trial designs usually benefit only a small population sub-group. Targeted-therapy matched clinical trials have a higher potential to achieve better results, however, given the low frequency of driver genetic alterations, they are associated with a large number of screen-failures, are not cost-effective, and frequently not feasible. Lung-MAP is an umbrella master protocol for recurrent or metastatic lung SCC patients that uses a central genomic profiling screening platform to allocate patients to phase II/III biomarker-matched target therapy clinical trials or to a “non-match” treatment arm; therefore, all eligible patients screened can be treated under the protocol. If evidence of efficacy is seen in the phase II trial portion for a particular treatment/marker combination, that sub-study moves directly to phase III and incorporates the patients treated in phase II. Lung-MAP has an efficient and adaptable structure that allows for sub-studies to open and close based on changes in an evolving cancer research field. It also provides a path for FDA-approval in order to bring promising agents to clinic in a time efficient manner, with the ultimate goal of significantly improving lung SCC patient’s quality and length of life.},
	issn = {2304-3873},	url = {http://cco.amegroups.com/article/view/7845}
}