Current Readings: Window-of-Opportunity Trials for Thoracic Malignancies

Recent major advances in metastatic non–small cell lung cancer have occurred with the identification of molecular biomarker targets and administration of novel agents with resulting improvement in clinical outcomes. In the early-stage setting, personalized therapy with novel agents and molecular profiling are being incorporated into neoadjuvant “window-of-opportunity” trials. These important studies enable biomarker research and an expedited analysis of the efficacy of the targeted agent. However, there are significant limitations to window-of-opportunity trials. The aim of this article is to review the current window-of-opportunity trials of neoadjuvant targeted agents for thoracic malignancies, discuss the benefits and limitations of these trials, and propose more optimal alternative trial end points. Neoadjuvant trials of resectable non–small cell lung cancer and mesothelioma that are ongoing or under development and relevant to thoracic surgeons are also discussed. The success of these trials will depend on a collaborative multidisciplinary effort, especially from the field of thoracic surgery.