Going into BATTLE: umbrella and basket clinical trials to accelerate the study of biomarker-based therapies

With the recognition that tumor molecular phenotypes may predict response to targeted therapies, a number of national multi-center umbrella and basket trials have been initiated in recent years. Umbrella trials enroll patients with a single tumor type, defined by primary anatomic site, and assign various treatments according to the molecular characterization of each case. Conversely, basket trials enroll patients with multiple tumor types, restricting eligibility according to biomarker status. Examples of both models abound, including the Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis (I SPY) trials in breast cancer (1), Lung Master Protocol (Lung MAP) trial in advanced squamous lung cancer (2), Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) in surgically resected non-small cell lung cancer (NSCLC) (3), Lung Cancer Mutation Consortium (LCMC)-associated trials in advanced lung adenocarcinoma (4), the National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (NCI MATCH) Trial (5), and the Targeted Agent and Profiling Utilization Registry (TAPUR) (6), sponsored by the American Society of Clinical Oncology (ASCO) in previously treated advanced solid tumors.