Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-Friends Recommendations
AbstractPurpose:. Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of trial results. We examined the impact of broadening select eligibility criteria on characteristics and number of patients eligible for trials, using recommendations of the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research.Experimental Design:. A retrospective, observational analysis used electronic health record data from ASCO’s CancerLinQ Discovery database. Study cohort included patients with advanced non–small cell lung cancer treated from 2011 to 2018. Patients were grouped by traditional criteria [no brain metastases, no other malignancies, and creatinine clearance (CrCl) ≥ 60 mL/minute] and broadened criteria (including brain metastases, other malignancies, and CrCl ≥ 30 mL/minute).Results:. The analysis cohor
