Lung-MAP-framework, overview, and design principles

Renata Ferrarotto, Mary W. Redman, David R Gandara, Roy S. Herbst, Vassiliki A. Papadimitrakopoulou

Research output: Contribution to journalReview articlepeer-review

23 Scopus citations


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.

Original languageEnglish (US)
Article number36
JournalChinese Clinical Oncology
Issue number3
StatePublished - 2015


  • Clinical trial
  • Lung cancer
  • Master protocol
  • Squamous cell carcinoma (SCC)

ASJC Scopus subject areas

  • Oncology
  • Medicine(all)


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