title: Lung-MAP--framework, overview, and design principles.
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.
authors.affiliation: Department of Thoracic and Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center, USA.
authors.forename: Renata
authors.initials: R
authors.lastname: Ferrarotto
authors.affiliation: Clinical Statistics, Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
authors.forename: Mary W
authors.initials: MW
authors.lastname: Redman
authors.affiliation: University of California Davis Cancer Center, Sacramento, CA, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Gandara
authors.affiliation: Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA.
authors.forename: Roy S
authors.initials: RS
authors.lastname: Herbst
authors.affiliation: Department of Thoracic and Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center, USA. vpapadim@mdanderson.org.
authors.forename: Vassiliki A
authors.initials: VA
authors.lastname: Papadimitrakopoulou
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000473:pathology / Q000628:therapy*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D057166:High-Throughput Screening Assays / Q000379:methods*; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000628:therapy*; D058990:Molecular Targeted Therapy / Q000379:methods*; D009362:Neoplasm Metastasis; D012107:Research Design
keywords: Clinical trial; lung cancer; master protocol; squamous cell carcinoma (SCC)