Challenges of the phase I drug development in non-small cell lung cancer

In this article, the challenges and strategies of phase 1 drug development for lung cancer are discussed. These include the use of precise dose determinations via statistical modelling, the improved selection of patients based on genetic or molecular biomarkers, relevant pharmacokinetic and pharmacodynamic analyses, and the early evaluation of efficacy. The application of molecular tumor profiling for individualizing therapy is increasingly seen in phase I trials. Finally, the implication of a shift towards multi-institutional trials and centralized study management are discussed.