84P - Racial disparities in phase I lung cancer clinical trials

Background

Lung cancer is the leading cause of cancer-related deaths worldwide and disproportionately affects racial and ethnic minorities. We aimed to assess the enrollment of minorities in phase I clinical trials for lung cancer.

Methods

We searched the clinicaltrials.gov database for completed phase I clinical trials conducted in adult patients from 2010 to 2022. To ensure the relevance and generalizability of our findings, we included trials conducted in North America, Europe, and Australia, while excluding those restricted to Southeast Asia or focused on radiation or screening interventions. We manually abstracted data on the racial distribution of enrollees, tumor histology, therapeutics, and year of trial reporting. To quantify the enrollment of each racial group, we calculated the enrollment fraction for each subgroup as the number of trial enrollees within that subgroup divided by the estimated number of incident cases in that subgroup during a given period. We used the Z test for proportions to compare enrollment fractions between racial groups, with Whites as the comparator group.

Results

We identified 193 phase I clinical trials, and 132 met our inclusion criteria for analysis. Racial data was available in 89 studies (67.5%) that included 11,359 participants: 9439 White (83%), 508 African American (4.5%), 898 Asian (8%), and 513 other participants (4.5%). The frequency of race reporting increased over time, with racial data included in 37% of studies in 2010-2014, 51% in 2015-2019, and 93% in 2020-2022. Comparison of enrollment fractions between 2015-2019 showed that African Americans were significantly underrepresented compared to Whites (z=5.2, p<0.00001). Table: 84P

Conclusions

Our study highlights the continued underrepresentation of minorities in phase I clinical trials for lung cancer. To ensure equity in trial participation and the generalizability of developmental therapeutic trials in lung cancer, it is necessary to implement multilevel, culturally, and linguistically tailored strategies.

Clinical trial identification

Editorial acknowledgement

No assistance

Legal entity responsible for the study

R. Singh.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.