Underrepresentation of Patients From Racial and Ethnic Minorities in Immunotherapy Clinical Trials for Non-Small Cell Lung Cancer.

BACKGROUND: Landmark immunotherapy trials have transformed treatment of non-small cell lung cancer (NSCLC), yet underrepresentation of racial and ethnic minorities threatens the generalizability of trial findings. This study evaluated disparities in receipt of immunotherapy during clinical trial periods preceding regulatory approval. METHODS: Using the National Cancer Database, we assessed receipt of immunotherapy by patients diagnosed with metastatic NSCLC between 2004 and 2015 and resectable stage II-IIIB NSCLC between 2004 and 2021, corresponding to immunotherapy clinical trial periods for metastatic and resectable disease, respectively. Multivariable adjusted logistic regression was used to evaluate associations between race and ethnicity and receipt of immunotherapy. Additional sensitivity analyses were performed among subgroups of patients with insurance, who reside in high-income areas, received treatment at academic facilities, have no comorbidities, and received chemotherapy. RESULTS: In multivariable analyses of patients with metastatic disease, Black (odds ratio [OR], 0.81; 95% CI, 0.76-0.88), Asian (OR, 0.84; 95% CI, 0.74-0.95), and Hispanic (OR, 0.79; 95% CI, 0.71-0.89) patients were significantly less likely than non-Hispanic White patients to receive immunotherapy. Disparities persisted in sensitivity analyses, including of insured patients treated at academic centers in high-income areas. Notably, Black patients residing in the highest income areas remained less likely to receive immunotherapy than White patients residing in the lowest income areas (OR, 0.63; 95% CI, 0.42-0.96). Similar disparities were observed in the neoadjuvant setting. CONCLUSIONS: Patients from racial and ethnic minorities were significantly less likely to receive immunotherapy during clinical trial periods for NSCLC, even in populations with comparable access to care. These findings emphasize persistent inequities in early access to novel therapies and the need for targeted strategies to improve trial representation.