The oncology field pioneered adaptive trial designs through efforts such as I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2), Puma Biotechnology Inc.’s phase II study of the pan-HER tyrosine kinase inhibitor neratinib (Nerlynx) as neoadjuvant therapy in metastatic breast cancer, and the ongoing multidrug, biomarker-driven
non-small-cell lung cancer trial known as Lung-MAP.