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Lung Cancer “Master Protocol” Eyed As Paradigm-Changing Approach To Drug Development

 
• By Sue Sutter

The biomarker-driven, multi-arm, multi-drug registration trial is expected to get under way in March 2014 with five drugs from different sponsors. With the promise of greater speed and efficiency in patient enrollment and late-stage development, it is being viewed as a potential model for other cancer settings.

A first-of-its-kind “master protocol” for a Phase II/III registration trial in lung cancer not only could lead to new treatments for advanced squamous cell disease, it could fundamentally change the clinical development paradigm for new oncologics in the U.S. and elsewhere.

Governmental entities, research and advocacy communities, and the pharmaceutical and device industries have come together through a public-private partnership to create a novel infrastructure for conducting a biomarker-defined, multi-arm, multi-drug registration trial in second-line, non-small cell lung cancer. Details about the master protocol were announced Nov

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