Lessons from ADAURA: Can we improve on a positive trial?

Abstract

Although ADAURA (ClinicalTrials.gov identifier NCT02511106) was a positive trial that produced a significant improvement in both disease‐free survival and overall survival, the limited crossover to postprotocol osimertinib and some other methodological issues detract from the cancer community's ability to distinguish the benefits of timing of osimertinib versus overall access to osimertinib at a later point. Discrete refinements can be applied to global, randomized phase 3 trials to ensure their design optimally addresses the key clinical question while reducing disparities in best management practices based on resources across health care systems.