What Is a Master Protocol Trial? Lung-MAP Explained

A master protocol trial is a single, large trial infrastructure that can test multiple different investigational drugs at once, matching patients to different treatment arms based on their specific tumor's molecular profile.

Lung-MAP (Lung Cancer Master Protocol) is a notable example in lung cancer research: a collaboration of many research sites across the country using a shared trial infrastructure to match patients with advanced non-small cell lung cancer to one of several investigational drugs, based on genomic testing results.

This design offers efficiency advantages over running many separate, independent trials: a shared screening and enrollment infrastructure, shared control-arm data in some designs, and the ability to add or remove individual drug arms over time as new investigational treatments become available or existing ones complete testing.

Master protocol trials are technically still clinical trials themselves — patients enrolled are participating in ongoing research, not receiving an established standard treatment outside a trial context.