Investigating disparities in enrollment of patients in lung cancer clinical trials that led to FDA approval for immunotherapies between 2015 and 2023: A comparison with the US population.

e23104 Background: Registrational clinical trials have led to the FDA approval of numerous immunotherapy (IO) agents in the treatment of non-small cell lung cancer (NSCLC) since 2015. Given the historical lack of adequate representation of the US population with cancer in clinical trials, we aimed to analyze disparities in race and ethnicity reporting and enrollment in lung cancer clinical trials that led to FDA-approved immunotherapies between 2015-2023. Methods: The FDA archives and database were queried to review all FDA drug approvals for IO approved to treat NSCLC between 2015 to 2023. Enrollment data were obtained from FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. The enrollment incidence ratio (EIR) and enrollment mortality ratio (EMR) were calculated as the proportion of patients of a particular race among clinical trial participants in approval studies divided by the estimated proportion of patients of that particular race diagnosed or dying of lung cancer, respectively, among the US population. Results: Among 27 trials with a total of 15,878 subjects, distribution by race shows that 77.5% were White, 16.7% Asian, 8.8% Hispanic, 1.63% Black, 0.33% American Indian Alaska Native (AIAN), and 0.07% were Native Hawaiian and Other Pacific Islander (NHOPI). 67.4% were males while 32.6% were females. The EIR for Non-Hispanic White, Non-Hispanic Black, Asian, and Hispanic patients was 0.99, 0.13, 3.56, and 0.85 respectively. The EMR for Non-Hispanic White, Non-Hispanic Black, Asian, and Hispanic patients was 0.99, 0.12, 4.23, and 0.96 respectively. Racial demographics were reported in 65% of journal manuscripts, 65% of ClinicalTrials.gov pages, and 92% of FDA labels while ethnicity demographics were reported in 0% of journal manuscripts, 42% of ClinicalTrials.gov pages, and 15% of FDA labels. Conclusions: Black, AIAN and female patients are severely underrepresented in lung cancer trials that lead to approval for IO based therapy. Asian patients were overrepresented. Less than half of the trials reported data on ethnicity. Further research is needed to see if regulatory initiatives to increase clinical trial diversity result in more equitable clinical trial enrollment in pivotal trials.