Opportunity Information: Apply for W81XWH 15 LCRP CEA
Apply for W81XWH 15 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 Apr 8, 2015 and posted on Apr 8, 2015.
- Applicants must submit their applications by Sep 16, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,240,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 4 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 funding opportunity under the Department of Defense Lung Cancer Research Program (LCRP) designed to push forward early, proof-of-principle clinical work that could meaningfully change how lung cancer is treated. The program emphasizes hypothesis-driven, innovative interventions aimed at overcoming real clinical barriers in lung cancer management. The intent is not to fund large definitive trials right away, but to generate strong clinical and biological evidence that an approach is worth advancing into larger, efficacy-focused studies that could ultimately shift standards of care. Since the mechanism was introduced in FY2013, it has been relatively selective, with 35 applications received and 5 recommended for funding at the time this notice was released, signaling a competitive award that prioritizes impactful ideas and credible early clinical testing plans.
This opportunity supports two main project types. The first is the Clinical Trials category, which funds early-stage clinical testing in lung cancer, specifically Phase 0, Phase I, or pilot Phase II studies. These trials can involve drugs or drug combinations, Class II or Class III medical devices, or other trial types that fit the early exploratory purpose. A key requirement is that the approach being tested should be novel and "outside the box" in the context of lung cancer, meaning it should represent a meaningful conceptual advance rather than an incremental tweak. At the same time, the program explicitly allows applicants to repurpose therapies that are already in clinical use or being tested in other diseases, as long as the proposed lung cancer application would plausibly create a major advancement in treatment. The underlying theme is high-risk, high-reward early clinical exploration grounded in a clear hypothesis and a plan to produce interpretable, decision-enabling results.
The second supported project type is the Correlative Studies category. This track is meant for hypothesis-based correlative studies that build on clinical trials that are ongoing or already completed but funded through other sources. Rather than paying for the parent clinical trial itself, the CEA in this category supports the kind of embedded or follow-on translational research that can explain why a therapy works, who it works for, and what biological changes it triggers in lung cancer. The goal is practical clinical insight: improving treatment strategies, identifying patient subsets most likely to benefit, understanding mechanisms of action or resistance, characterizing immune responses tied to progression or response, and developing or validating biomarkers that can predict prognosis, therapeutic response, or disease progression. Examples listed in the announcement include biomarker analyses, studies of drug mechanism and resistance, immune response profiling, and tumor antigen characterization that could inform improved therapies.
From an applicant and collaboration standpoint, eligibility is listed as unrestricted, meaning the announcement is open to a wide range of organizations, subject to any clarifications in the full text. However, the DoD makes a strong programmatic push for involvement from military-relevant research environments. Submissions from, and partnerships with, investigators at military treatment facilities, military laboratories, and Department of Veterans Affairs (VA) medical centers and research labs are explicitly encouraged. This reflects the DoD interest in strengthening networks that connect civilian lung cancer research with military and veteran health systems, and in ensuring that promising interventions can be tested and translated in settings relevant to service members and veterans.
Administratively, this opportunity (Funding Opportunity Number W81XWH-15-LCRP-CEA) was issued by the Department of the Army through USAMRAA, with funding offered as grants and cooperative agreements under CFDA 12.420 (Military Medical Research and Development). The program anticipated making about 4 awards, with an estimated total funding level of $2.24 million, and it did not require cost sharing or matching. The posting date was April 8, 2015, with an original and final closing date of September 16, 2015, and an archive date of October 16, 2015. Additional guidance on clinical trial definitions, phases, and related human subjects considerations is referenced through the Human Subject Resource Document available via eBRAP, and applicants needing help with the electronic announcement were directed to the CDMRP Help Desk (help@eBRAP.org, 301-682-5507).
DoD Lung Cancer Clinical Exploration Award (CEA) - FAQs
What is the DoD Lung Cancer Clinical Exploration Award (CEA)?
The Lung Cancer Clinical Exploration Award (CEA) is a funding opportunity under the Department of Defense (DoD) Lung Cancer Research Program (LCRP) intended to advance early, proof-of-principle clinical work that could meaningfully change how lung cancer is treated. It emphasizes hypothesis-driven, innovative interventions aimed at overcoming real clinical barriers in lung cancer management.
What is the main purpose of this award?
The purpose is to generate strong clinical and biological evidence that an approach is worth advancing into larger, efficacy-focused studies that could ultimately shift standards of care. The award is not intended to fund large, definitive trials at the outset.
How competitive is this funding opportunity?
The mechanism has been relatively selective. Since it was introduced in FY2013, the notice indicated 35 applications were received and 5 were recommended for funding at the time the notice was released, suggesting a competitive program focused on impactful ideas with credible early clinical testing plans.
What types of projects are supported?
This opportunity supports two main project types: (1) Clinical Trials and (2) Correlative Studies.
What qualifies under the Clinical Trials category?
The Clinical Trials category supports early-stage clinical testing in lung cancer, specifically Phase 0, Phase I, or pilot Phase II studies. These trials may involve drugs or drug combinations, Class II or Class III medical devices, or other trial types consistent with an early exploratory purpose.
Which clinical trial phases are allowed?
Phase 0, Phase I, and pilot Phase II clinical studies are supported under the Clinical Trials category.
What does the program mean by "outside the box" or novel approaches?
The approach being tested should be novel in the context of lung cancer and represent a meaningful conceptual advance rather than an incremental tweak. The program is oriented toward high-risk, high-reward early clinical exploration grounded in a clear hypothesis and a plan to produce interpretable, decision-enabling results.
Are repurposed therapies allowed?
Yes. The program explicitly allows applicants to repurpose therapies that are already in clinical use or being tested in other diseases, as long as the proposed application in lung cancer could plausibly create a major advancement in treatment.
What is the Correlative Studies category?
The Correlative Studies category supports hypothesis-based correlative research that builds on clinical trials that are ongoing or already completed but funded through other sources. The award does not pay for the parent clinical trial itself; it supports embedded or follow-on translational research designed to provide practical clinical insight.
Does the Correlative Studies category fund the underlying clinical trial?
No. In this track, the CEA supports correlative/translational studies tied to trials funded through other sources, rather than funding the parent clinical trial.
What kinds of questions should correlative studies address?
Correlative studies are intended to help explain why a therapy works, who it works for, and what biological changes it triggers in lung cancer. The goal is to inform improved treatment strategies and decision-making in clinically useful ways.
What example topics are mentioned for Correlative Studies?
Examples include biomarker analyses; studies of drug mechanism and resistance; immune response profiling tied to progression or response; and tumor antigen characterization that could inform improved therapies. The announcement also notes developing or validating biomarkers that can predict prognosis, therapeutic response, or disease progression.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning the announcement is open to a wide range of organizations, subject to any clarifications in the full announcement text.
Are military or VA collaborations required?
The information provided does not state that they are required, but the DoD strongly encourages submissions from, and partnerships with, investigators at military treatment facilities, military laboratories, and Department of Veterans Affairs (VA) medical centers and research labs.
Why does the DoD encourage military treatment facility and VA involvement?
This reflects DoD interest in strengthening networks connecting civilian lung cancer research with military and veteran health systems, and in ensuring that promising interventions can be tested and translated in settings relevant to service members and veterans.
What agency issued this funding opportunity?
The opportunity was issued by the Department of the Army through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is W81XWH-15-LCRP-CEA.
What type of funding instrument is used?
Funding is offered as grants and cooperative agreements.
What is the CFDA number associated with this program?
The CFDA listing is 12.420 (Military Medical Research and Development).
How many awards were anticipated and what was the estimated total funding?
The program anticipated making about 4 awards, with an estimated total funding level of $2.24 million.
Is cost sharing or matching required?
No. The opportunity indicated that cost sharing or matching was not required.
What were the key dates for this opportunity?
The posting date was April 8, 2015. The original and final closing date was September 16, 2015. The archive date was October 16, 2015.
Where can applicants find guidance on clinical trial definitions and human subjects considerations?
Additional guidance on clinical trial definitions, phases, and related human subjects considerations is referenced through the Human Subject Resource Document available via eBRAP.
Who should applicants contact for help with the electronic announcement?
Applicants needing assistance with the electronic announcement were directed to the CDMRP Help Desk at help@eBRAP.org or 301-682-5507.
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