The National Cancer Institute (NCI) has released a Notice of Funding Opportunity (NOFO) for "Scaling-up and Maintaining Evidence-based Interventions to Maximize Impact on Cancer (SUMMIT) - Lung Cancer Screening (UG3/UH3 Clinical Trial Required)." This opportunity invites proposals for research projects aimed at advancing the scale-up and sustainment of lung cancer screening (LCS) for high-risk populations, particularly those experiencing health inequities. Successful applicants will conduct trials testing implementation strategies to increase the adoption, effective delivery, and sustainability of LCS across diverse clinical settings. The funding supports a two-phase project: an initial exploratory phase (UG3) followed by an implementation phase (UH3).

The overall objective of this NOFO is to ensure that LCS, an evidence-based intervention for the early detection of lung cancer using low-dose computed tomography (LDCT), reaches a broader population, with special attention to underserved groups. This intervention has been shown to reduce lung cancer mortality, and the NOFO seeks to increase both access and quality of care by focusing on equitable delivery across at least 60 diverse clinical sites. The key processes of LCS involve identifying eligible individuals, engaging in shared decision-making (SDM), and ensuring follow-up care, among others. Importantly, the NOFO requires that LCS delivery be measured at least 12 months after implementation to assess its sustainment.

Applicants must use a randomized controlled trial design, such as a cluster or stepped-wedge design, to test the implementation strategies for scaling and sustaining LCS. The application should include measures that align with the core set of common measures developed in the broader SUMMIT Initiative, promoting consistency and comparability across different trials. Engagement with key partners—such as healthcare systems, community advisory boards, and clinical providers—is critical for the successful development and implementation of the research. Additionally, projects should consider economic evaluations and cost-effectiveness analyses to ensure scalability and sustainability of the proposed interventions.

The NOFO emphasizes the importance of inclusivity and diversity, and requires a Plan for Enhancing Diverse Perspectives (PEDP). The PEDP aims to improve the scientific merit of projects by fostering team diversity and ensuring that underrepresented groups are included in both the research teams and participant populations. Failure to include a PEDP will result in administrative withdrawal of the application before review. This focus is intended to encourage scientific innovation and ensure that the research benefits are widely shared, especially among those who have been underserved in the past.

The UG3/UH3 cooperative agreement mechanism requires applicants to propose milestones for the initial UG3 phase, which must be met to proceed to the UH3 phase. The UG3 phase involves preparing for the trial, refining the implementation strategies, and ensuring the participating sites are ready to conduct the research. Successful completion of these milestones, reviewed administratively by NCI, is a prerequisite for advancing to the UH3 phase, which supports the actual implementation and evaluation of LCS at scale. The maximum project period is two years for the UG3 phase and four years for the UH3 phase, with a budget cap of $500,000 and $850,000 per year for each phase, respectively.

The application must address all essential component processes of LCS and include clear plans for measuring patient engagement and retention, as well as adherence to screening protocols. The NOFO specifies that applications must include at least 60 sites that are diverse in terms of size, location, and resources, and must justify the selection of these sites. Furthermore, the trial should target diverse populations, with a focus on those experiencing health disparities in lung cancer outcomes.

Applicants are required to submit their proposals through NIH's ASSIST system or Grants.gov by December 6, 2024. A letter of intent, although not mandatory, is encouraged 30 days before the application deadline. The project will undergo peer review to assess scientific and technical merit, as well as adherence to the specific requirements of this NOFO, including the PEDP. Award decisions will be based on merit, availability of funds, and relevance to NCI's program priorities. Selected projects will be part of the larger SUMMIT Initiative, which includes a Steering Committee and collaborative activities designed to promote the sharing of data and methodologies across different trials aimed at improving cancer outcomes.