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Chin Clin Oncol. 2015 Sep;4(3):36. doi: 10.3978/j.issn.2304-3865.2015.09.02.

Lung-MAP--framework, overview, and design principles.

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Department of Thoracic and Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center, USA.
Clinical Statistics, Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
University of California Davis Cancer Center, Sacramento, CA, USA.
Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Department of Thoracic and Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center, USA.


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.


Clinical trial; lung cancer; master protocol; squamous cell carcinoma (SCC)

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