The biomarker-driven Lung Cancer Master Protocol (Lung-MAP) may have enrolled a higher percentage of patients who are older, are from rural or socioeconomically deprived areas, and have Medicaid or no insurance compared with conventional, standalone clinical trials in advanced non–small cell lung cancer (NSCLC), according to a study published by Vaidya et al in JCO Precision Oncology.
Background
The Lung-MAP partnership included the National Cancer Institute (NCI) and its National Clinical Trials Network, the SWOG Cancer Research Network, Friends of Cancer Research, the Foundation for the National Institutes of Health, Foundation Medicine, pharmaceutical companies providing their drugs for the study, and several lung cancer advocacy organizations. The recent trial has provided an infrastructure for conducting a portfolio of biomarker-driven clinical trials in NSCLC under a shared screening protocol.
“Lung-MAP is the first protocol conducted within the [National Clinical Trials Network] as a public-private partnership,” explained lead study author Riha Vaidya, PhD, of the SWOG Statistics and Data Management Center and Fred Hutchinson Cancer Center. “There isn't any published data on whether this partnership approach improves access to clinical trials over conventionally conducted trials. So, our goal was to examine the sociodemographic characteristics of patients enrolled [in] Lung-MAP and how they compared to other SWOG trials for advanced NSCLC,” she added.
Lung-MAP Sociodemographic Analysis
In the analysis, researchers involved in the Lung-MAP study sought to determine whether the master protocol approach improved access to trials, particularly for groups historically underrepresented in clinical research studies. The researchers compared the sociodemographic characteristics of the 3,556 patients enrolled in the Lung-MAP study from June 2014 to December 2020 with those of a set of 2,215 patients enrolled in other advanced NSCLC clinical trials conducted by the SWOG Cancer Research Network.
The researchers found that compared with the patients enrolled in other NSCLC studies, the patients enrolled in the Lung-MAP study were more likely to be aged 65 or older (57.2% vs 46.3%), live in a rural area (17.3% vs 14.4%), live in a neighborhood classified as socioeconomically deprived based on its Area Deprivation Index score (42.2% vs 36.7%), and have Medicaid insurance or no health insurance (27.6% vs 17.8%, excluding patients aged 65 and older). However, the patients who participated in the Lung-MAP study were less likely than those enrolled in other trials to identify as female (38.6% vs 47.2%), Asian (2.8% vs 5.1%), or Hispanic (2.4% vs 3.8%).
Conclusions
The researchers noted that prior to 2019, Lung-MAP enrollment was limited to patients with squamous cell carcinoma, a tumor histology that is significantly more common among male patients than female patients.
“Our finding of improved access to clinical trials for some underrepresented patient groups provides an opportunity to examine how we can apply site and patient engagement practices from Lung-MAP to other trials, so we can reach more patients,” Dr. Vaidya underscored. “We have more work to do, particularly regarding representation of racial and ethnic minority groups. SWOG's DEI infrastructure will be critical in identifying and resolving barriers to trial access for these patient groups,” she concluded.
Disclosure: The research in this study was funded by the NCI and in part by AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Genentech, and Pfizer through the Foundation for the National Institutes of Health in partnership with Friends of Cancer Research. For full disclosures of the study authors, visit ascopubs.org.
