“…Therefore, the DEDICATION-1 trial has been designed to serve as a platform for extensive biomarker research that investigates multiple biomarkers (e.g., liquid biopsies, proteomics, pharmacokinetics and immunopharmacology, exhaled breath, artificial intelligence (AI)-based lung imaging, computational pathology, and the microbiome) in order to assess their utility–both individually and within the context of a compound biomarker–in predicting (non-)response to pembrolizumab-containing treatment. Importantly, the trial design allows for the development of predictive biomarkers that are able to identify both primary treatment resistance (e.g., predictive biomarkers that predict (non-)response before start or early after start of treatment) and secondary treatment resistance (e.g., monitoring biomarkers that can be applied to identify (non-)response during course of treatment) ( Buma et al, 2021 ; van Delft et al, 2022 ; Buma et al, 2023 ). In parallel, an early Health Technology Assessment (HTA) analysis is being performed to assess the value of biomarker-guided treatment selection by providing high-quality research information on the effectiveness, costs, and impact of the implementation of such an approach ( Ferraro et al, 2022 ).…”