Racial demographic reporting in clinical trials supporting NCCN NSCLC guidelines.

Abstract

e13739 Background: Non-Small Cell Lung cancer (NSCLC) demonstrates marked global racial and ethnic disparities in incidence and mortality, with higher rates observed in Black populations, and lower rates in Asian/Pacific Islanders. NCCN Clinical Practice Guidelines play a central role in standardizing NSCLC care; however, the racial and ethnic composition of the clinical trials in forming these guidelines has not been systematically evaluated. Methods: We reviewed 1163 references from the NCCN NSCLC Guidelines (Version 8.2025), identifying 411 eligible clinical trials. We evaluated each study for the reporting of race, geographic location, and publication year. We performed descriptive analyses and used Fisher’s exact test to evaluate trends in reporting over time and across U.S.-based versus international studies. Results: Of the 411 eligible NSCLC trials, only 170 (41.4%) reported participant racial data. The frequency of race reporting increased significantly over time, from 9.5% in 1980-1999 to 53.2% in 2020-2025 (p = 0.0003). Among trials reporting race, participants were predominantly White (~82%), with substantially lower representation of Asian (6.8%), Black (4.5%), non-white (4.3%), and Hispanic (1.6%) patients, and minimal inclusion of American Indian/Alaska Native (0.3%), Native Hawaiian/Pacific Islander (0.4%), and more than one race (0.2%). Although the proportion of White participants declined over time, significant reductions were observed only in later eras, including comparisons between 2000-2004 and 2020-2025 (p = 0.0073), 2005-2009 and 2020-2025 (p = 0.0336), 2010-2014 and 2020-2025 (p = 0.0001), and 2010-2014 and 2015-2019 (p = 0.0280). Conclusions: Although race reporting in NSCLC clinical trials has increased over time, it remains inconsistent with persistent racial inequities, and continued underrepresentation of Black, Hispanic, Native American, and Pacific Islander patients relative to non-Hispanic White population, partly due to international trials conducted in more racially homogeneous populations, limiting generalizability to diverse nations like the United States and increasing risk of care disparities. These findings necessitate standardized race and ethnicity reporting and an equity-driven trial design to ensure that guideline evidence is equitable and effective for all patients. Moreover, these findings highlight structural contributors to racial and ethnic disparities in the evidence base underlying guideline-directed NSCLC care and underscore the need for standardized demographic reporting and equity-centered trial design. Future guideline development and trial eligibility frameworks should incorporate minimum standards for demographic reporting and enrollment diversity to enhance the representativeness and clinical applicability of evidence used to guide cancer care.