Developing biomarker-specific end points in lung cancer clinical trials

Evaluating overall survival improvement as a cancer clinical trials end point is time-consuming and costly, but traditional radiographic measurements of tumours might not accurately reflect clinical benefit due to confounding factorsMolecular imaging aims to augment traditional radiographic measurements by differentiating malignant from normal tissues in order to better capture biological or molecular responses to therapyCirculating tumour factors, such as proteins, DNA, and cells, hold great promise as early predictors of therapeutic response and disease recurrenceTumour-derived factors present in the circulation might also enable early detection of molecular resistance markers and provide information on tumour heterogeneityPharmacodynamic biomarkers evaluate the biological, molecular, and functional effects of a drug on its target, potentially offering insights into mechanisms of action of new compounds and/or validating new targetsValidation of specific biomarkers requires their broad inclusion in clinical trials for assessment of performance