Lung-MAP—framework, overview, and design principles

摘要: 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 small population sub-group. Targeted-therapy matched trials have higher potential to achieve better results, however, given the low frequency of driver genetic alterations, they are associated large number screen-failures, not cost-effective, frequently feasible. Lung-MAP an umbrella master protocol for recurrent or metastatic SCC patients that uses central genomic profiling screening platform allocate phase II/III biomarker-matched target therapy "non-match" treatment arm; therefore, all eligible screened can be treated under protocol. If evidence efficacy seen in II portion particular treatment/marker combination, sub-study moves directly III incorporates II. has efficient adaptable structure allows sub-studies open close based on changes evolving cancer research field. It also provides path FDA-approval order bring promising agents clinic time manner, ultimate goal significantly improving patient's quality length life.