HT942526LCRPTRA_GG.pdf

This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Lung Cancer Research Program Translational Research Award

Funding Opportunity Number: HT942526LCRPTRA

Pre-Application Due: June 23, 2026

Application Due: September 02, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Lung Cancer Translational Research Award 2

Content

Before You Begin 3

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Translational Research Award; provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes for application compliance review, pre-application and full application selection/notification, and risk assessment. Also, details the review criteria for pre-application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

FY26 Lung Cancer Translational Research Award 3

Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:%7E:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Lung Cancer Translational Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Lung Cancer Research Program (LCRP) Translational Research Award (TRA) supports advanced translational research that will foster transformation of promising ideas in lung cancer into clinical applications. Research must address at least one of the FY26 LCRP areas of emphasis.

Distinctive Features: This funding mechanism intends to support a broad range of translational studies and allows application submission under: Funding Level 1 – Advanced/late-stage preclinical work or correlative studies; or Funding Level 2 – Pilot clinical trials of novel interventions.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $9.1M to fund approximately six TRA applications with total cost caps of $1.35M per award for Funding Level 1 and $1.85M per award for Funding Level 2. The maximum period of performance is 3 years for Funding Level 1 awards and 4 years for Funding Level 2 awards.

It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), June 23, 2026

• Invitation to Submit an Application: July 30, 2026

• Application Submission Deadline: 11:59 p.m. ET, September 02, 2026

• End of Application Verification Period: 5:00 p.m. ET, September 04, 2026

• Peer Review: October 2026

• Programmatic Review: January 2027 Announcement Type: Initial Funding Opportunity Number: HT942526LCRPTRA Assistance Listing Number: 12.420

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Lung Cancer Translational Research Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Independent investigators affiliated with an eligible organization are eligible to be named Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status.

The PI must be an independent investigator at any career level.

An investigator may be named as a PI on only one application per funding level for this Translational Research Award program announcement.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:%7E:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

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Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Lung Cancer Research Program (LCRP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the LCRP in 2009 to promote innovative and competitive research focused on the development of integrated disciplines to identify, treat, and manage early curable lung cancer (excluding mesothelioma). Appropriations for the LCRP from FY09 through FY24 totaled $245.5 million (M). The FY26 appropriation is $20M.

The vision of the FY26 LCRP is to eradicate deaths and suffering from lung cancer to better the health and welfare of Service Members, Veterans and the general public. As such, the LCRP will support and integrate research from multiple disciplines for risk assessment, prevention, early detection, diagnosis, management, and treatment for the control and cure of lung cancer and its sequelae.

To meet the intent of the funding opportunity, all applications must address at least one of the FY26 LCRP Areas of Emphasis in a way that can lead to or directly effect a breakthrough and have a major impact. The LCRP developed a strategy to address multiple issues in lung cancer research over the cancer continuum of care spectrum that will be considered for funding under the LCRP. These areas of emphasis are critical gaps in cancer research, care, and/or patient outcomes that, if addressed, will lead to reduced suffering from lung cancer and improved quality of life of Service Members, Veterans and the general public.

Simply identifying an area of emphasis is not sufficient.

3.1. Intent of the Translational Research Award

The FY26 LCRP Translational Research Award (TRA) mechanism supports advanced translational research that will foster the transformation of promising ideas in lung cancer into clinical applications. Translational research may be defined as an integration of basic science and clinical observations. Observations that drive a research idea may originate from a laboratory discovery, population-based studies, or a clinician’s firsthand knowledge of patient care. The ultimate goal of translational research is to move a concept or observation forward into clinical application. However, PIs should not view translational research as a one-way continuum from bench to bedside, but rather as a process that includes a reciprocal flow of ideas and information between basic science and clinical science (bench to bedside and/or bedside to bench). Research applications only in the area of mesothelioma will not be accepted. This mechanism intends to fund a broad range of translational studies with two different funding levels. The following are general examples, although not all-inclusive, of the types of research projects that would be appropriate to propose under the current program announcement:

Funding Level 1:

• Advanced preclinical studies aimed at translating results from animal studies to applications with human samples/cohorts. (The Translational Research Award is not intended to support initial mechanistic studies of a new target.)

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FY26 Lung Cancer Translational Research Award 7

• Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submission.

• Correlative studies that are associated with an open/ongoing or completed clinical trial, e.g., projects that utilize biospecimens from clinical trials to improve clinical management of lung cancer and/or define new areas of research.

• Projects that develop endpoints for clinical trials.

Funding Level 2:

• Pilot clinical trials where limited clinical testing (e.g., small sample size) of a novel intervention is necessary to inform the next step in the continuum of translational research.

3.1.1. Areas of Emphasis for the TRA

• Biology and Etiology

○ Understand the molecular mechanisms of initiation and progression of pre-malignancy to lung cancer.

○ Understand contributors to lung cancer development other than tobacco, including hereditary and sex-specific differences.

○ Understand the biology of metastatic/oligometastatic disease progression.

• Prevention and Risk Reduction

○ Identify innovative strategies for the prevention and/or interception of lung cancer development.

○ Identify innovative strategies for the prevention of recurrence or metastases from lung cancer.

• Detection, Diagnosis and Surveillance

○ Improve and expand approaches to screening and early detection of lung cancer.

○ Identify strategies for prompt detection and/or characterization of progressive disease.

• Treatment and Prognosis

○ Identify innovative strategies for the treatment of lung cancer, including overcoming resistance.

○ Develop or optimize biomarkers to assist with therapeutic decision making.

○ Enhance the understanding, detection, and treatment of brain and leptomeningeal metastases in lung cancer.

• Health Outcomes and Survivorship

○ Identify and understand the long-term and cumulative effects of lung cancer and its treatment(s) on quality of life for patients and families.

○ Identify and understand the impact of comorbidities on survivorship care in all stages of lung cancer.

○ Reduce differences among high-risk groups and populations.

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FY26 Lung Cancer Translational Research Award 8

3.1.2. Key Elements for the TRA

Key elements of this award mechanism are as follows:

• Preliminary Data: Preliminary lung cancer-relevant data to support the feasibility of the research hypotheses and research approaches are required.

• Translation: Movement of promising, well-founded laboratory or clinical research findings into clinical applications for patients with, or populations at risk for, lung cancer.

• Impact: Research that has high potential impact may lead to major advancements and significantly accelerate progress toward eradicating deaths and suffering from lung cancer.

3.1.3. Other Important Considerations for the TRA

Relevance to Military Health: The LCRP seeks to support research that is relevant to the health care needs of Service Members, Veterans and their Families. The LCRP strongly encourages investigators to consider the following characteristics as examples of how a project may demonstrate relevance to military health:

• Use of military or Veteran populations, biospecimens, data/databases, or programs in the proposed research.

• Collaboration with DOW or U.S. Department of Veterans Affairs (VA) investigators.

• Explanation of how the project addresses an aspect of lung cancer that has relevance or is unique to the military, Veterans, other MHS beneficiaries, or Family readiness of Service Members, including environmental exposures other than tobacco.

All investigators applying to FY26 LCRP funding opportunities are encouraged to consider leveraging resources from the LCRP-funded Lung Cancer Biospecimen Resource Network (LCBRN) if retrospectively collected human anatomical substances and correlated clinical data are relevant to the proposed studies. Samples from the LCBRN are currently available through the Cooperative Human Tissue Network (CHTN). To request LCBRN samples, contact the Division Coordinator for the CHTN Mid-Atlantic Division (email: CHTN-MidAtl@hscmail.mcc.virginia.edu) located at the University of Virginia.

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, CDMRP does not support the conduct of painful research (U.S. Department of Agriculture pain category D or E) involving domestic cats or dogs, except for studies relating to military or service animals.

Clinical research is permitted and clinical trials are allowed within Funding Level 2 for this funding opportunity.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the VA and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

mailto:CHTN-MidAtl@hscmail.mcc.virginia.edu https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:%7E:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines

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FY26 Lung Cancer Translational Research Award 9

The following encouragement is broadly applicable across many CDMRP programs, including the LCRP. A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY26 LCRP priorities.

3.2. Funding Instrument

The funding instrument for awards made under the program announcement will be grants

(31 USC 6304).

3.3. Funding Details

Funding Level 1:

Period of Performance: The maximum period of performance is 3 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.35M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

Funding Level 2:

Period of Performance: The maximum period of performance is 4 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.85M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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FY26 Lung Cancer Translational Research Award 10

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 LCRP Translational Research Award.

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FY26 Lung Cancer Translational Research Award 11

4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

Pre-application submissions must include the following components.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (two-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The inclusion of preliminary lung cancer-relevant data pertinent to the proposed project is required.

The Preproposal Narrative should include the following:

○ Research: State the project’s hypothesis/objective, scientific rationale, and specific aims; and describe the study design and its feasibility. Describe the translational aspect of this proposed project, providing evidence for the reciprocal transfer of ideas between basic and clinical science in developing and implementing the proposed research into clinical applications in lung cancer.

If the proposed research includes a pilot clinical trial, briefly state the clinical intervention and subject population(s).

If a pilot clinical trial is proposed, provide the readiness date and/or the anticipated

First Patient In date and a brief timeline for accrual and endpoints readout.

○ Impact: Describe the applicability of the research on patients with lung cancer, and describe how the proposed project will lead to critical discoveries or major advancements that will accelerate progress toward eradicating deaths and suffering from lung cancer. Briefly explain how the proposed research addresses at least one of the FY26 LCRP Areas of Emphasis.

• Pre-Application Relevance Questions: Provide responses for the following three questions in the appropriate eBRAP data fields:

○ Is the applicant and/or collaborator(s) currently affiliated with the military and/or VA?

(Yes/No) https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:%7E:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:%7E:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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○ Does the proposed research include the use of military and/or VA resources (e.g., data, patient samples)? (Yes/No) If yes, specify the resource and how the resource will be accessed to conduct the proposed research (500-character limit, including spaces).

○ Clearly articulate how the proposed research is relevant to military Service Members, Veterans and their Families; include supporting evidence as applicable to the proposed research (500-character limit, including spaces).

• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative.

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications, and previous work accomplished.

4.3. Full Application Components

Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected.

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (15-page limit): Upload as

“ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

Applications proposing a pilot clinical trial must include preliminary data.

– Background: Present the ideas and reasoning behind the proposed research. The application must provide a sound scientific rationale to support the proposed project and its feasibility as established through the demonstration of logical reasoning and critical review and analysis of published literature; include relevant literature citations.

Include preliminary data to support the scientific rationale and feasibility of the research approaches. Applications are strongly encouraged to also include preliminary data to support the clinical relevance of the idea. Any unpublished, https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=(a)%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:%7E:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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FY26 Lung Cancer Translational Research Award 13 preliminary data provided should originate from the laboratory of the PI or a member(s) of the research team.

– Hypotheses/Objectives: State the hypotheses/study questions and overall objective(s) to be reached.

– Specific Aims: Concisely explain the project’s specific aims. If this application is part of a larger study, present only tasks that this award would fund.

– Research Strategy and Feasibility: Describe the experimental design, methods, and analyses, including appropriate controls, in sufficient detail for analysis. If applicable, describe how collaborations support the research. Address potential problem areas and present alternative methods and approaches. If the proposed study involves animals, a summary describing the animal research that will be conducted must be included in the application. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported. If human subjects or human biological samples will be used, include a detailed plan for the recruitment of subjects or the acquisition of samples. For all applications proposing clinical research or clinical trials describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial, and ethnic group, and an accompanying rationale for the selection of subjects. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, sex, ethnicity, or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race, and ethnicity should be provided as part of the application’s Supporting Documentation (Attachment 2).

If funds for a pilot clinical trial are requested, details regarding the Clinical Trial Strategy must be described in Attachment 8. Only those proposed studies measuring safety, effectiveness, and/or efficacy of an intervention are considered clinical trials and should submit a Clinical Trial Strategy.

– Statistical Analysis Plan: Describe the statistical analysis plan for the resulting outcomes. If applicable, include a complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study. Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the U.S. Food and Drug Administration (FDA), if applicable.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Lung Cancer Translational Research Award 14 facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (one-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

Letters of Commitment (if applicable): If the proposed study involves use of a commercially produced investigational drug, device, or biologic, provide a letter of commitment from the commercial entity indicating the availability of the product for the duration of the study, support for the proposed phase of research, and support for the indication to be tested.

Use of DOW and/or VA Resources (if applicable): If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding, or other agreements required to access and publish data. Refer to the GAI, Appendix 4, for additional considerations.

Inclusion Enrollment Report (only required if clinical research or a clinical trial is proposed): Provide an anticipated enrollment table(s) for the inclusion of women and minorities using the “Public Health Service (PHS) Inclusion Enrollment Report", a three-page fillable PDF form, that can be downloaded from eBRAP. The enrollment table(s) should be appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex, race and ethnicity. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity, or race (typically classified as exempt from IRB review) are exempt from this requirement.

Sex as a Biological Variable Strategy (two-page limit is recommended):

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:%7E:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a

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FY26 Lung Cancer Translational Research Award 15 other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

Intellectual and Material Property Plan (if applicable): Provide a plan for resolving intellectual and material property issues among participating organizations.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g., for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Do not submit a copy of the National Institutes of Health Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”.

Write the technical abstract using the outline below. Clarity and completeness within the space limits are highly important.

Background: Present the scientific rationale behind the proposed research project.

Area(s) of Emphasis: State the FY26 LCRP Area(s) of Emphasis the project addresses.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached. Provide evidence or rationale that supports the hypothesis and/or objective(s).

Specific Aims: State the specific aims of the study.

Study Design: Describe the study design, including appropriate controls.

Impact: Summarize the potential impact of the proposed project toward the goal of eradicating deaths and suffering from lung cancer. Describe how the project will translate promising, well-founded laboratory or clinical research findings into clinical applications for patients with, or populations at risk for, lung cancer. State explicitly how the research will ultimately accelerate the movement of promising ideas toward clinical applications. If applicable, describe how the anticipated outcomes of the https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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FY26 Lung Cancer Translational Research Award 16 proposed study will make an impact in understanding health differences between sexes.

Military Relevance: Describe how the study is relevant to military health.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

– Summarize the objectives and rationale for the proposed research.

– State the FY26 LCRP Area(s) of Emphasis the project addresses.

– What population will the research help, and how will it help them?

– What are the potential applications, benefits, and risks of the anticipated outcomes?

– What are the likely contributions of the proposed research project to advancing research, patient care and/or quality of life?

– What is the potential benefit of the proposed study and the anticipated outcomes to

Service Members, Veterans and/or their Families?

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to either the Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work or Example: Assembling a Generic Statement of Work, whichever is most appropriate for the proposed effort. Include milestones for data or research resource(s) sharing.

○ Attachment 6: Impact Statement (one-page limit): Upload as “Impact.pdf”. The Impact Statement should be written in a manner that is readily understood by readers without a background in science or medicine. Describe how the proposed research is relevant to at least one of the FY26 LCRP Areas of Emphasis and describe how the research will make an impact. The relevance of all research should relate to patient outcomes and how it benefits those affected by lung cancer. Describe how the project will translate promising, well-founded laboratory or clinical research findings into clinical applications for patients with, or populations at risk for, lung cancer. If applicable, describe how the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes. Describe how the proposed research will lead to major advancements with a significant impact on lung cancer research and/or patient care, including its potential to accelerate progress toward eradicating deaths and suffering from lung cancer.

○ Attachment 7: Transition Plan (two-page limit): Upload as “Transition.pdf”. Provide information on potential methods and strategies to feasibly move the project’s findings to the next phase of development, clinical trials, and/or delivery to the commercial market after successful completion of the award. The transition plan should include the components listed below.

– A description of the scientific or technical requirements needed to advance the research findings.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Lung Cancer Translational Research Award 17

– An assessment of the opportunities available and potential barriers that would impact the progress of commercializing and/or translating the study results into clinical practice.

– A timeline with defined milestones and deliverables describing the expected post-award progress of the results toward the next phase of development and eventual clinical impact.

– Details of the funding strategy that will be used to bring the outcomes to the next phase of development. Provide sufficient evidence that the PI has secured or can secure additional funding, and describe potential options to secure the additional funding needed to bring the outcomes to the next phase of development (e.g., specific potential industry partners and/or specific funding opportunities to apply for).

– A description of collaborations and other resources that will be used to provide continuity of development.

– A plan to distribute the findings, research resources, or interventions to the lung cancer community.

○ Attachment 8: Clinical Trial Strategy, required only for Funding Level 2 (no page limit): Upload as “Clinical.pdf”. Only those proposed studies measuring safety, effectiveness, and/or efficacy of an intervention are considered clinical trials and should submit a Clinical Trial Strategy.

– Describe the scientific rationale for the proposed clinical trial. Demonstrate how the proposed clinical trial is supported by strong preliminary data and relevant literature citations. Provide a description of the intervention and the endpoints to be measured.

Articulate the type of clinical trial to be performed (e.g., randomized, cohort, case-control, cross-sectional) and outline the proposed methodology in sufficient detail to show a clear course of action. Provide detailed plans for initiating the clinical study within the first year, including FDA IND/Investigational Device Exemption (IDE) application submission plans within 60 days of the award, if applicable. Define the study population; indicate the access to the study population, recruitment plans, and inclusion/exclusion criteria; and include a justification for the plans and alternative strategies, if issues arise. Describe the informed consent process.

– Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study; include a description of the composition of the proposed study population in terms of sex, racial, and ethnic group; and include a rationale for the selection of subjects. Provide anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race, and ethnicity using the PHS Inclusion Enrollment Report. The enrollment table(s) should be appropriate to the objectives of the study.

– Describe the type of clinical trial to be performed (e.g., prospective, randomized, controlled) and outline the proposed methodology in sufficient detail to show a clear course of action. Describe potential challenges and alternative strategies where appropriate. Describe how the clinical trial will inform the correlative clinical research, if applicable.

– If the proposed clinical trial was initiated using other funding prior to this application, explain the history and background of the clinical trial and declare the source of prior funding.