Racial disparities in molecularly targeted trials of tyrosine kinase inhibitors (TKI) for the perioperative management of oncogene-driven non-small cell lung cancer (NSCLC): A systematic review.

Abstract

e20015 Background: The treatment of non-small cell lung cancer (NSCLC) has experienced a significant shift with the introduction of targeted therapies. While the utility of targeted therapies for the perioperative management of oncogene-driven NSCLC is rapidly evolving through molecularly targeted trials, racial disparities of patient (pt) enrollment in these trials remains uncharacterized. Methods: A systematic review of 27 clinical trials from ClinicalTrials.gov, conducted between 2003 and 2024, was performed to evaluate targeted therapies in resectable NSCLC. Data on genomic alterations, outcomes, demographics, drugs, trial phases, racial distribution and geographic representation were collected. Results: Most studies, 67% (18/27) evaluated therapies targeting EGFR mutations, followed by ALK (26%), ROS1 (14.8%), MET (7.4%), KRAS (7.4%), BRAF (3.7%), and RET (3.7%). Out of 27 studies, 18.5% (5/27) were completed, 18.5% (5/27) were recruiting, 29.6% (8/27) were active but not recruiting, 22.2% (6/27) were not yet recruiting, 3.7% (1/27) was terminated, and 7.4% (2/27) had an unknown status. Most (70.3%) trials were phase II, with a primary endpoint of Objective Response Rate (ORR). Sample size data were only reported in seven (25.9%) studies, with a cumulative reported enrollment of 993 participants. Women accounted for 64.9% of participants, while men represented 34.5%. Racial distribution reported by a few studies was 14.8% (4/27) with a sample size of 969 and revealed underrepresentation of Black (0.1%), Hispanic (0.2%), and other racial groups (1.2%), while White and Asian participants constituted 37.8% and 60.7%, respectively. Studies were predominantly conducted in China (59.2%,16/27) and the United States (44.4% 12/27). Conclusions: Targeted therapies continue to transform the management of resectable oncogene-driven NSCLC, offering significant potential to improve outcomes in this subset of patients. However, disparities in racial representation and geographic distribution persist, underscoring the need for more inclusive and globally representative research. Future studies should address these disparities, explore resistance mechanisms, and optimize therapy combinations to broaden the impact of targeted therapies in diverse patient populations.