Notice of Intent to Publish a Funding Opportunity Announcement for Scaling-up and Maintaining Evidence-based Interventions to Maximize Impact on Cancer (SUMMIT)- Lung Cancer Screening (UG3/UH3 Clinical Trial Required)

Key Dates

None

National Cancer Institute (NCI)

The National Cancer Institute (NCI) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications to the Scaling-up and Maintaining Evidence-based Interventions to Maximize Impact on Cancer (SUMMIT) Lung Cancer Screening (LCS) initiative. Up to three (3) Research Projects are expected to be funded as part of SUMMIT LCS initiative.

Each Research Project will advance the science of scale-up and sustainment by testing strategies to increase and sustain the delivery of high-quality guideline concordant LCS among populations at high-risk for lung cancer.

The NOFO is expected to use the UG3/UH3 Exploratory/Developmental Cooperative Agreement activity code with the Clinical Trials Required designation. Awards made under this NOFO will initially support a two-year maximum milestone driven UG3 phase with a possible transition to a four-year maximum UH3 phase. During the UG3 phase, scale-up and sustainment strategies will be refined and preparatory activities for the scale-up and sustainment trial will occur. NCI will conduct an administrative review of UG3 milestones. Projects that do not complete UG3 milestones will not be approved to move forward to the UH3 phase. The scale-up and sustainment trial will be conducted during the UH3 phase.

The NOFO is expected to be published in late Summer 2024 with an expected application due date in late Fall 2024. Details of a pre-application webinar will be announced after the publication of the NOFO. This Notice is being provided to allow sufficient time for potential applicants with relevant expertise and insights to consider applying for this NOFO.

Potential applicants are encouraged to view the presentation of this initiative to the Joint Virtual Meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board available at https://videocast.nih.gov/watch=54859 beginning at 3 hour, 57 minutes. Presentation slides are downloadable at https://deainfo.nci.nih.gov/advisory/joint/0624/Chambers.pdf.  
 

Lung cancer causes the most deaths of any cancer type, with an estimated 127,070 deaths in the U.S. in 2023, and has one of the lowest five-year survival rates (25.4%) among all cancer types. Mortality rates are particularly high for populations experiencing health disparities (e.g., Hispanic, Non-Hispanic Black, American Indian/Alaska Native, and Asian and Pacific Islander). Despite these dire statistics, rates of lung cancer screening (LCS) remain low, which poses a significant barrier toward reducing lung cancer mortality.

Delivery of high-quality guideline concordant LCS is a multi-component and multi-step process. Clinical practice guidelines include 8 core components of the full LCS process: 1) identifying LCS eligible individuals, 2) engaging individuals in shared decision making (i.e., education on characterizing risk) to determine if they wish to proceed with screening, 3) offering tobacco cessation interventions, 4) ordering and conducting low-dose computed tomography imaging for those who decide to undergo screening, 5) interpreting and reporting results, 6) managing normal and abnormal findings, 7) ensuring appropriate follow-up care, and 8) promoting adherence to repeat annual LCS while an individual remains eligible.

To meet the research goals of SUMMIT LCS, applications must include the following: 

• Use of a randomized controlled trial design (e.g., parallel cluster randomized, stepped-wedge cluster randomized, and other types of randomized designs) to test strategies to scale-up and sustain the delivery of LCS for populations at high-risk for lung cancer; 
• A minimum of 60 sites, for which a single site may include (but is not limited to) a primary care clinic, specialty care clinic, community cancer center, Federally Qualified Health Center clinic, and/or other contexts in which LCS is provided;
• Measurement of the delivery of LCS services (offered and provided) at least 12 months after full implementation;
• Use of validated measures;
• Sites that are diverse in size, location, and resources;
• Populations that are diverse in race, sex and gender identity, ethnicity, geography, and socioeconomic status; and
• Populations experiencing health disparities and health inequities.

All applications must include a clinical trial to be responsive to this NOFO. Trials proposed must meet the NIH definition of a clinical trial (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) and should contribute to the advancement of evidence-based medicine/practice and the sciences that support it.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Wynne E. Norton, PhD
National Cancer Institute (NCI)
Division of Cancer Control and Population Sciences
Telephone: 240-276-6875
Email: wynne.norton@nih.gov

Cynthia A. Vinson, PhD, MPA
National Cancer Institute (NCI)
Division of Cancer Control and Population Sciences
Telephone: 240-276-6745
Email: cvinson@mail.nih.gov