Opportunity Information: Apply for W81XWH 13 LCRP CEA
Apply for W81XWH 13 LCRP CEA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Lung Cancer Clinical Exploration Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on May 21, 2013 and posted on May 21, 2013.
- Applicants must submit their applications by Oct 16, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $720,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The DoD Lung Cancer Clinical Exploration Award (CEA) is a Department of Defense Lung Cancer Research Program funding opportunity designed to jump-start early, proof-of-principle clinical work that could meaningfully change how lung cancer is managed. Introduced for the first time in fiscal year 2013, the program is aimed at supporting hypothesis-driven, innovative clinical interventions and the correlative studies that help explain why an intervention works (or does not work). The larger goal is to tackle persistent clinical roadblocks in lung cancer care by backing ideas that are creative, high-impact, and grounded in a clear scientific rationale, with the expectation that successful results will justify and enable larger, later-stage efficacy trials.
A central theme of this award is testing "outside the box" approaches in real clinical settings, but at an early stage where feasibility, safety signals, biological activity, and early evidence of potential benefit can be assessed. Proposed therapeutic strategies must be novel in the context of lung cancer, yet they do not have to be entirely new to medicine. The opportunity explicitly allows investigators to repurpose therapies that are already used clinically or currently being evaluated for other diseases, as long as the proposed lung cancer application is truly innovative and could represent a major step forward in treatment. This creates space for rapid translation of promising concepts into lung cancer trials, rather than limiting applicants only to brand-new compounds or technologies.
The CEA specifically supports early-phase clinical trials, including Phase 0, Phase I, and pilot Phase II studies. Eligible trial types include evaluations of drugs or drug combinations, studies involving Class II or Class III medical devices, and other early clinical testing efforts that explore novel approaches to lung cancer. The emphasis is on clinical exploration rather than large confirmatory studies, meaning the award is intended to generate the kind of initial human data and accompanying mechanistic insights that can later support a well-powered, efficacy-focused clinical trial program.
From an administrative and funding perspective, this is a discretionary Department of the Army opportunity administered through USAMRAA (U.S. Army Medical Research Acquisition Activity) under the Military Medical Research and Development CFDA listing (12.420). The funding instrument is listed as a cooperative agreement or grant, with an expected number of awards of one and an estimated total funding amount of $720,000. There is no cost-sharing or matching requirement noted. Eligibility is described as unrestricted, meaning any type of entity may apply, subject to any additional eligibility clarifications contained in the full announcement.
The program also signals a strong interest in collaborations tied to military and veteran health systems. Submissions from, and partnerships with, investigators at Military Medical Treatment Facilities, military laboratories, and Department of Veterans Affairs (VA) Medical Centers and research labs are encouraged. This reflects the DoD focus on leveraging the military and VA research and clinical infrastructure, and it may also align the funded work with populations and care settings relevant to service members and veterans.
Key dates for the FY13 announcement include a posted and creation date of May 21, 2013, with an original and current closing date of October 16, 2013, and an archive date of November 15, 2013. The funding opportunity number is W81XWH-13-LCRP-CEA, and the title is "DoD Lung Cancer Clinical Exploration Award." For applicants who could not access the full announcement electronically, the notice provided a point of contact through the CDMRP Help Desk at 301-682-5507.
Frequently Asked Questions (FAQs): DoD Lung Cancer Clinical Exploration Award (CEA)
What is the DoD Lung Cancer Clinical Exploration Award (CEA)?
The DoD Lung Cancer Clinical Exploration Award (CEA) is a Department of Defense Lung Cancer Research Program funding opportunity intended to jump-start early, proof-of-principle clinical work that could meaningfully change how lung cancer is managed.
What is the main goal of this award?
The main goal is to support hypothesis-driven, innovative clinical interventions and correlative studies that help explain why an intervention works (or does not work), with the expectation that promising results will justify and enable larger, later-stage efficacy trials.
What types of studies does the CEA emphasize?
The CEA emphasizes early clinical exploration in real clinical settings, including studies designed to assess feasibility, safety signals, biological activity, and early evidence of potential benefit.
What clinical trial phases are supported under this opportunity?
This opportunity specifically supports early-phase clinical trials, including Phase 0, Phase I, and pilot Phase II studies.
Are large, confirmatory (efficacy-focused) clinical trials supported?
No. The emphasis is on clinical exploration rather than large confirmatory studies. The award is intended to generate initial human data and mechanistic insights that can later support a well-powered efficacy-focused clinical trial program.
What kinds of interventions or trial types are considered eligible?
Eligible trial types include evaluations of drugs or drug combinations, studies involving Class II or Class III medical devices, and other early clinical testing efforts that explore novel approaches to lung cancer.
Do the proposed therapies have to be completely new to medicine?
No. Proposed therapeutic strategies must be novel in the context of lung cancer, but they do not have to be entirely new to medicine.
Does the program allow repurposing of existing therapies?
Yes. The opportunity explicitly allows investigators to repurpose therapies that are already used clinically or currently being evaluated for other diseases, as long as the proposed application in lung cancer is truly innovative and could represent a major step forward in treatment.
What does "outside the box" mean in the context of this award?
It refers to testing creative, non-traditional approaches in real clinical settings at an early stage, focusing on feasibility, early safety signals, biological activity, and preliminary signs of benefit rather than definitive proof of efficacy.
What are "correlative studies" and why are they important here?
Correlative studies are studies conducted alongside a clinical intervention to help explain the biological or mechanistic reasons an intervention works or does not work. This award specifically highlights correlative work as a way to generate insight that can guide future, larger trials.
When was the CEA introduced?
The Clinical Exploration Award was introduced for the first time in fiscal year 2013.
Which federal organization administers this funding opportunity?
This is a discretionary Department of the Army opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What is the CFDA listing associated with this opportunity?
The opportunity is administered under the Military Medical Research and Development CFDA listing (12.420).
What is the funding instrument for this opportunity?
The funding instrument is listed as a cooperative agreement or grant.
How many awards are expected to be made?
The expected number of awards is one (1).
What is the estimated total funding amount?
The estimated total funding amount is $720,000.
Is cost-sharing or matching required?
No. There is no cost-sharing or matching requirement noted.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning any type of entity may apply, subject to any additional eligibility clarifications contained in the full announcement.
Are collaborations with military or veteran health systems encouraged?
Yes. Submissions from, and partnerships with, investigators at Military Medical Treatment Facilities, military laboratories, and Department of Veterans Affairs (VA) Medical Centers and research labs are encouraged.
Why does the opportunity encourage military and VA collaborations?
The program reflects a DoD focus on leveraging military and VA research and clinical infrastructure, and it may also align the funded work with populations and care settings relevant to service members and veterans.
What is the funding opportunity number?
The funding opportunity number is W81XWH-13-LCRP-CEA.
What is the official title of the opportunity?
The official title is "DoD Lung Cancer Clinical Exploration Award."
When was the opportunity posted?
The posted (and creation) date is May 21, 2013.
What were the closing dates for this FY13 announcement?
The original closing date was October 16, 2013, and the current closing date was also October 16, 2013.
When was the opportunity archived?
The archive date was November 15, 2013.
Who can applicants contact if they cannot access the full announcement electronically?
Applicants were provided a point of contact through the CDMRP Help Desk at 301-682-5507.
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