Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302).
Authors: Carrizosa Daniel R. , Miao Jieling , Reckamp Karen L. , Dragnev Konstantin H. , Hesketh Paul Joseph , Iams Wade Thomas , Henick Brian S. , Czerlanis Cheryl M. , DeSanto Frank , Sundstrom Jamie , Johnson Judy , Gansauer Lucy , Groller Tiffany , Redman Mary Weber , Herbst Roy S. , Gray Jhanelle E. 
Published: June 2024

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Background: Studies show that <10% of patients with cancer participate in clinical trials. Pragmatica – Lung (SWOG S2302) utilizes a pragmatic approach for a registrational (FDA) trial that allows less data collection and broader eligibility, thus decreasing barriers to diverse enrollment. S2302 aims to improve overall and diverse accrual by using a novel trial design and multilevel community engagement. Methods: S2302 is a real-world randomized phase III registrational study comparing pembrolizumab + ramucirumab vs investigator-chosen standard therapy in 2nd line advanced/metastatic NSCLC. A multi-stakeholder recruitment plan was developed to improve diverse accrual (with initial focus on recruiting Black patients). The plan was vetted through SWOG communications and SWOG Lung Committee’s Working Group, DEI champion, patient advocate, and community engagement subcommittee. The DEI champion identified sites in the Southeast with high minority accrual in prior trials and completed directed informational visits. An external firm created culturally and linguistically appropriate patient education material, engaged sites with historically high accrual of Black and/or LatinX patients, leveraged advocacy partners to improve community awareness, and monitored enrollment by site. A monthly accrual report with demographic summaries (including age, sex, race, ethnicity) and site enrollment information is generated from SWOG Statistics and Data Management Center to monitor accrual rate and diversity. Results: From March through December 2023 (Table), the study accrued 37% of its goal and is enrolling above its target rate of 25 pts/mo averaging 36/mo over the last 5 months. Of enrolled pts, 58% are male, 13% are Black, and 3% are LatinX; from 59 academic, 67 community (13% rural), and 2 VA sites. Comparatively, LungMAP S1800A (the phase II precursor to S2302) accrued 7% Black and 1.5% LatinX pts with an average accrual of 9.2 pts/mo. Through November, the external firm contacted 24 site PIs (63% community-based), whose sites had collectively enrolled 16 pts, for a normalized pre-call rate of 0.1340 pts/mo. After contact and through November, these sites enrolled 23 pts, a rate of 0.3835 pts/mo – a 186% increase. Conclusions: The intentional, multi-pronged recruitment plan has exceeded historical overall, Black, and LatinX patient accrual rates. The data highlight novel approaches to trial design, recruitment strategies, and increased internal and external collaboration resulting in improved diversity of clinical trial enrollment and may be a potential toolkit for future trials. Support: NIH/NCI grants U10CA180888 and U10CA180819; and in part by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and Eli Lilly and Company. Clinical trial information: NCT05633602 . [Table: see text]