Operational strategies for faster, more efficient pivotal NSCLC trials

Non-small-cell lung cancer (NSCLC) exemplifies personalized medicine: many clinical trials target patients with specific genetic markers and prior treatment regimens. Phase II and III trials are thus operationally complex and fiercely competitive. Increasing molecular segmentation, the rapid evolution of first-line standards of care (SOC), and competition among trial sponsors for a dwindling pool of eligible patients are three significant challenges to patient enrollment. 

Recruiting patients with advanced or metastatic disease who have failed prior therapies is especially difficult because these patients often have poor performance status scores, making travel to sites difficult, and they may have rapidly progressive disease, which requires fast and efficient eligibility testing.

Despite the challenges, sponsors can quickly recruit enough patients by focusing on data-driven site selection, careful protocol optimization, efficient eligibility screening, and ongoing patient and site engagement. At Parexel, we have conducted more than 150 NSCLC trials in the past five years. We have found that successfully delivering later-phase trials depends on discarding traditional assumptions and managing foreseeable challenges.