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Master Protocol for squamous cell lung cancer readies for launch

Nature Biotechnology volume 32, pages 116–117 (2014)Cite this article

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The master protocol is a “truly exciting development, one that will benefit industry and patients,” says US Food and Drug Administration (FDA) Commissioner Margaret Hamburg. “It vastly increases the chances of finding more and better treatments.” Although a concept paper from several years ago laid the groundwork, the practical genesis of the master protocol was a brainstorming session early during 2012, according to oncologist David Gandara of the University of Davis, California, part of the steering committee whose members worked out details for the protocol. “We concluded the classic drug development paradigm needed to be revised because it takes seven and a half years to complete and has too many failures,” he says.

Other biomarker-driven screening trials are already under way, such as I-SPY2 (Box 1) for breast cancer and BATTLE-2 for non-small cell lung cancer. But the master protocol is pioneering in that it aims to create an infrastructure that could be applicable to other types of cancer and other diseases as well. It also allows successful agents to be followed into phase 3, whereas experimental agents in I-SPY2 'graduate' after phase 2. “We hope that this serves as a prototype,” says Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

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Change history

  • 29 May 2014

    In the version of this article initially published, Genentech's compound Taselisib was incorrectly labeled as Pictilisib in Table 1. The error has been corrected in the HTML and PDF versions of the article.

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    Jeffrey L Fox

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Fox, J. Master Protocol for squamous cell lung cancer readies for launch. Nat Biotechnol 32, 116–117 (2014). https://doi.org/10.1038/nbt0214-116b

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