Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis.

Abstract

LBA108 Background: Restrictive trial eligibility criteria limit data generalizability and patient opportunity to participate. We compared numbers and characteristics of patients (pts) eligible using traditional vs expanded criteria recommended by ASCO and Friends of Cancer Research. Methods: A retrospective, observational analysis used deidentified EHR data from ASCO’s CancerLinQ database. Study cohort included adult aNSCLC pts with ≥2 visits and ≥1 dose of systemic treatment post-advanced-disease diagnosis from 2011-2018. Recorded creatinine clearance (CrCl) or Cockcroft-Gault variables were required. Pts were grouped by traditional criteria (no brain metastases, no other malignancies and CrCl >60 mL/min) and expanded criteria (brain metastases and other malignancies allowed and CrCl >30 mL/min). Results: 10,500 pts were identified (Table). Median age 67.6 years [IQR 60.3-74.4]. 56% were male, and 65% white. 60% were Stage IV, 80% former or current smokers. 5005 (47.7%) pts were excluded by traditional exclusion criteria, while only 154 (1.5%) pts were excluded by expanded criteria. Expanded criteria patients were older (67.5 v 66.1, p<0.001); and more likely to be female (44% v 40%), Stage IV (60% v 55%), have non-squamous histology (47% v 45%), and never smokers (16% v 13%). Additional analysis is needed to differentiate treated/stable vs. active brain metastases. Conclusions: Use of the ASCO-Friends expanded criteria would enable nearly twice as many aNSCLC pts to be considered for trial participation (4,851 patients, 46.2%). Narrower criteria should only be used based on compelling scientific rationale for exclusion. [Table: see text]