Representativeness of patients enrolled in the Lung Cancer Master Protocol (Lung-MAP).
Authors: Vaidya Riha , Unger Joseph M. , Qian Lu , Minichiello Katherine , Herbst Roy S. , Gandara David R. , Neal Joel W. , Leal Ticiana , Patel Jyoti D. , Dragnev Konstantin H. , Waqar Saiama Naheed , Edelman Martin Joseph , Sigal Ellen V. , Adam Stacey , Malik Shakun M. , Blanke Charles David , LeBlanc Michael Leo , Kelly Karen , Redman Mary Weber 
Published: June 2022

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Background: A major goal of Lung-MAP, a biomarker-driven master protocol conducted within the National Clinical Trials Network of the NCI using a public-private partnership, was to improve access to novel therapeutics. Representative enrollment of patient sub-groups in clinical trials is essential for improving confidence that trial findings are valid and applicable to all patients. We examined the representativeness of patients enrolled in Lung-MAP by demographic and area-level measures compared to patients in other advanced non-small cell lung cancer (NSCLC) trials and with the US NSCLC population. Methods: We analyzed data on patients enrolled to Lung-MAP between 2014-2020 according to sex, age ( < 65 years v. ≥ 65 years), race (White v. Black v. Asian), ethnicity (Hispanic v. not Hispanic), residence (rural v. urban), insurance type (Medicaid or no insurance v. private), and neighborhood socioeconomic deprivation (quintiles of Area Deprivation Index score). Rates were compared to SWOG-led NSCLC trials conducted between 2001-2020 (date range to provide sufficient power) and, where possible, to US NSCLC population rates using Surveillance, Epidemiology, and End Results (SEER) registry data (2014-2018). Two-sided tests of proportions at the 5% level were used for all comparisons. Results: 3,556 patients enrolled to Lung-MAP were compared to 2,267 patients enrolled to SWOG-led NSCLC studies. Lung-MAP patients were more likely to be ≥ 65 years old (57.2% v. 46.7%; p <.001) and from rural areas (17.3% v. 14.3%; p =.002) but less likely to be female (38.6% v. 47.2%; p <.001), Asian (2.7% v. 5.1%; p < 0.0001), or Hispanic (2.4% v. 3.7%; p =.003). Compared to the US NSCLC population, Lung-MAP patients were less likely to be ≥ 65 years (57.2% v. 73.5%; p <.001), female (38.6% v. 47.8%; p <.001), or a racial or ethnic minority (15.5% v. 19.3%; p <.001). Lung-MAP patients were more likely to be from socioeconomically deprived neighborhoods (42.2% vs. 36.5%, p <.001). Among patients aged < 65 years, Lung-MAP enrolled more patients reporting Medicaid/no insurance as their primary insurance (27.6% v. 17.9%; p <.001). Conclusions: Lung-MAP improved access to novel therapeutics for older patients, rural patients, those with Medicaid/no insurance, and patients from socioeconomically deprived areas compared to other NSCLC trials. Lung-MAP enrolled exclusively squamous cell lung cancers from 2014-2018, which explains decreased representation of females. Consistent with prior research, Lung-MAP patients were younger and less diverse compared to the US NSCLC population. Further examination of the underrepresentation of Asian and Hispanic patients in Lung-MAP is required to identify barriers to access and potential solutions. The conduct of a master protocol across multiple locations may improve trial participation for patients with limited access due to area-level (rural, socioeconomic deprivation) or insurance barriers.