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 article

14 Scopus citations

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.

Original languageEnglish (US)
Article number36
JournalChinese Clinical Oncology
Volume4
Issue number3
DOIs
StatePublished - 2015

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Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Medicine(all)

Cite this

Ferrarotto, R., Redman, M. W., Gandara, D. R., Herbst, R. S., & Papadimitrakopoulou, V. A. (2015). Lung-MAP-framework, overview, and design principles. Chinese Clinical Oncology, 4(3), [36]. https://doi.org/10.3978/j.issn.2304-3865.2015.09.02