Micro AbstractIncreasing diversity in NSCLC clinical trials is crucial because it ensures that research results are generalizable to a broader patient population, reducing bias and promoting health equity. We evaluated racial/ethnic distributions of NSCLC clinical trial participants using ClinicalTrials.gov and compared it to corresponding NSCLC incidence data using SEER*Stat. With over 28,000 participants across 147 unique clinical trials, we found persistent underrepresentation among Black and Hispanic/Latino (H/L) clinical trial participants. IntroductionDespite efforts by Cancer Centers and community organizations to increase diversity in clinical trials, significant racial/ethnic disparities remain. Given the high mortality rates in non-small cell lung cancer (NSCLC), it is important to increase diversity in NSCLC trials, ensuring all patients benefit from advances in new treatment modalities. Materials and MethodsWe evaluated the distribution of racial/ethnic minority enrollment in NSCLC clinical trials using data from ClinicalTrials.gov. We extracted trial characteristics, including start year, study phase, tumor stage, sample size, sponsor, geographic region, and masking. The number of participants by race/ethnicity was obtained from ClinicalTrials.gov or linked publications. Using annual NSCLC incidence data from SEER*Stat for each racial/ethnic group from 2010 to 2019, we applied a two-sample test for equality of proportions with continuity correction to assess differences between incidence and trial participation. ResultsA total of 147 unique studies were included in the final analysis. Of the 28,540 participants, 79.6% were White, with 3% Black, 10.4% Asian or Pacific Islander and 3.4% Hispanic/Latino. Most participants were enrolled in phase III trials (63.8%), industry-sponsored (93.9%), and open-label (67.7%). Black patients were more commonly enrolled in academic sponsored trials and less commonly enrolled in masked (i.e., blinded) studies. When comparing trial participation to annual incidence data, we observed underrepresentation among Black participants (Difference: -7.9%) and Hispanic/Latino participants (Difference: -3.2%). ConclusionPersistent underrepresentation exists in NSCLC clinical trials among Black and Hispanic/Latino patients. We urge further investigation of these findings through well-designed clinical trials among diverse patient populations.