Opportunity Information: Apply for W81XWH 16 LCRP CEA

  • The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Lung Cancer Research Program 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.
  • This funding opportunity was created on Apr 11, 2016 and posted on Apr 11, 2016.
  • Applicants must submit their applications by Sep 14, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The number of recipients for this funding is limited to 2 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.
Apply for W81XWH 16 LCRP CEA

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Opportunity Summary:

The DoD Lung Cancer Research Program Clinical Exploration Award (CEA) is designed to fund early, proof-of-principle clinical trials that can be launched quickly and that test bold, hypothesis-driven interventions with real potential to change how lung cancer is managed in the clinic. The emphasis is on ideas that move beyond conventional lung cancer treatment strategies and directly address persistent clinical barriers. Although the program prioritizes novelty and "outside-the-box" thinking, the intervention itself does not have to be a brand-new molecule or device; it can also be a therapy already used clinically or being tested in other diseases, as long as the proposed application to lung cancer would represent a major step forward. The expected end product is not a definitive practice-changing Phase III trial, but strong early clinical evidence and scientific rationale that justify moving into larger, efficacy-focused studies that could ultimately transform care.

Funding under the CEA specifically supports early-phase clinical testing, including Phase 0, Phase I, and pilot Phase II trials, as well as trials involving Class II or Class III devices. The mechanism can cover trials of drugs, drug combinations, biologics, devices, surgical procedures, behavior modifications, and other therapeutic approaches, as long as the trial is truly interventional and focused on early clinical evaluation. A key restriction is that applications cannot be limited to correlative work tied to an existing or completed clinical trial; proposals that only analyze samples or data from other trials without testing a new intervention are not allowed under this mechanism. Applicants who mainly want to conduct correlative or translational studies are directed instead to other LCRP mechanisms (specifically, the Investigator-Initiated Translational Research Award referenced in the announcement).

The program lays out several concrete expectations for a competitive application, reflecting its focus on feasibility, rigor, and near-term clinical relevance. Applicants are expected to clearly identify the type of clinical study being proposed and to specify the clinical phase (or device class) when applicable. If the intervention requires regulatory authorization, the application must include documentation showing that an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) already exists. The proposed approach must be supported by a solid scientific rationale built on logical reasoning, a critical review of the existing literature, and preliminary data, with a clear explanation of why the idea is innovative and how it breaks from standard therapeutic thinking in lung cancer.

Operational readiness is also a major theme. The proposal needs to demonstrate that the research team has access to an appropriate human subject population and can realistically enroll enough participants to generate a meaningful result. It must also document that the intervention materials will be available in sufficient quantity for the study, such as including a manufacturer letter confirming supply of the agent and placebo if a placebo is required. On the design side, the trial must include well-defined, appropriate endpoints, along with a detailed statistical analysis plan. This includes a power analysis and sample size justification tied directly to the study objectives, rather than a vague statement that the trial is exploratory. Another practical requirement is speed: funded projects are expected to begin within 12 months of the award date, reinforcing that this mechanism is meant for studies that are ready to execute rather than long-term concept development.

A distinctive component is the required Transition Plan. Applicants must outline a realistic path for what happens after the CEA trial ends, describing how the results will be used to advance the intervention into subsequent clinical development. In other words, reviewers are looking for a credible bridge from an early signal of safety, feasibility, or biological/clinical activity to the next stage of testing, including how the team will position the work for larger trials and eventual impact on patient care.

The opportunity is open to a broad range of applicants (eligibility is described as unrestricted), and awards may be made as either grants or cooperative agreements through the DoD office administering the program (DOD-AMRAA). The announcement strongly encourages applications that involve collaborations with military treatment facilities, military laboratories, and Department of Veterans Affairs medical centers and research laboratories. Related to that, proposals must clearly explain relevance to military beneficiaries, meaning active-duty Service members, Veterans, and their families. This is not meant as a superficial statement; the application is expected to connect the lung cancer problem being addressed and the intervention being tested to the needs, exposures, care settings, or health outcomes pertinent to the military and Veteran populations.

Administrative details in the source listing include the funding opportunity number W81XWH-16-LCRP-CEA, a 2016 closing date of September 14, 2016, and an anticipated total of two awards. The award ceiling is not listed in the provided text. Overall, the CEA is best understood as a fast-moving clinical trial mechanism intended for teams that already have regulatory groundwork, access to patients and materials, and a compelling, unconventional therapeutic idea that can be tested quickly and positioned for follow-on clinical development.

Frequently Asked Questions (FAQs)

What is the DoD Lung Cancer Research Program Clinical Exploration Award (CEA)?

The Clinical Exploration Award (CEA) is a funding mechanism under the Department of Defense (DoD) Lung Cancer Research Program intended to support early, proof-of-principle clinical trials. It is focused on quickly launching bold, hypothesis-driven interventional studies that have real potential to change how lung cancer is managed clinically.

What is the main goal of the CEA?

The goal is to generate strong early clinical evidence and scientific rationale that can justify moving an intervention into larger, efficacy-focused studies. The CEA is not intended to fund a definitive, practice-changing Phase III trial.

What kinds of ideas does the CEA prioritize?

The CEA prioritizes novelty and "outside-the-box" approaches that move beyond conventional lung cancer treatment strategies and directly address persistent clinical barriers in lung cancer care.

Does the intervention have to be completely new?

No. The intervention does not have to be a brand-new molecule or device. It may be a therapy already used clinically or being tested in other diseases, as long as the proposed use in lung cancer represents a major step forward.

What clinical trial phases are supported by this award?

The CEA specifically supports early-phase clinical testing, including Phase 0, Phase I, and pilot Phase II clinical trials. It also supports trials involving Class II or Class III devices.

What types of interventions can be tested under the CEA?

Supported interventions can include drugs, drug combinations, biologics, devices, surgical procedures, behavior modifications, and other therapeutic approaches, as long as the study is truly interventional and focused on early clinical evaluation.

Are non-interventional or purely observational studies allowed?

The mechanism is intended for interventional clinical trials. Proposals that do not test an intervention (for example, those focused only on analysis without a new interventional study) are not aligned with the intent described.

Can an application be limited to correlative studies connected to another clinical trial?

No. Applications cannot be limited to correlative work tied to an existing or completed clinical trial. Proposals that only analyze samples or data from other trials without testing a new intervention are not allowed under this mechanism.

If my work is mainly correlative or translational, is there a more appropriate mechanism?

Yes. Applicants who mainly want to conduct correlative or translational studies are directed to other Lung Cancer Research Program mechanisms, including the Investigator-Initiated Translational Research Award referenced in the announcement.

What must applicants specify about the proposed clinical study?

Applicants are expected to clearly identify the type of clinical study being proposed and specify the clinical phase (or device class), when applicable.

What regulatory documentation is expected for drugs or devices that require authorization?

If the intervention requires regulatory authorization, the application must include documentation showing that an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) already exists.

What level of scientific support is expected for the proposed intervention?

The proposal is expected to include a solid scientific rationale supported by logical reasoning, a critical review of the existing literature, and preliminary data. Applicants should clearly explain why the idea is innovative and how it breaks from standard therapeutic thinking in lung cancer.

What does the CEA expect regarding patient access and enrollment feasibility?

The application should demonstrate that the research team has access to an appropriate human subject population and can realistically enroll enough participants to generate a meaningful result.

Do applicants need to show that the intervention materials will be available?

Yes. The application should document that intervention materials will be available in sufficient quantity for the study. For example, it may include a manufacturer letter confirming supply of the agent and placebo if a placebo is required.

What trial design and analysis elements are expected?

The trial should include well-defined, appropriate endpoints and a detailed statistical analysis plan. This includes a power analysis and sample size justification tied directly to the study objectives, rather than a vague statement that the trial is exploratory.

How quickly must funded projects begin?

Funded projects are expected to begin within 12 months of the award date, reflecting the program's emphasis on readiness and rapid execution rather than long-term concept development.

What is the Transition Plan and why is it required?

The Transition Plan is a required component describing what happens after the CEA-funded trial ends. Applicants must outline a realistic path for using the results to advance the intervention into subsequent clinical development, including positioning the work for larger trials and eventual impact on patient care.

Who is eligible to apply?

Eligibility is described as unrestricted, meaning the opportunity is open to a broad range of applicants based on the information provided.

What award instruments may be used for funding?

Awards may be made as either grants or cooperative agreements through the DoD office administering the program (DOD-AMRAA).

Are collaborations with military or VA partners encouraged?

Yes. The announcement strongly encourages collaborations with military treatment facilities, military laboratories, and Department of Veterans Affairs medical centers and research laboratories.

What does "relevance to military beneficiaries" mean in this opportunity?

Applications must clearly explain relevance to military beneficiaries, including active-duty Service members, Veterans, and their families. The relevance is expected to be substantive, connecting the lung cancer problem and the intervention to the needs, exposures, care settings, or health outcomes pertinent to military and Veteran populations.

What is the funding opportunity number listed for this CEA announcement?

The funding opportunity number provided is W81XWH-16-LCRP-CEA.

What closing date is listed in the provided information?

The source listing includes a 2016 closing date of September 14, 2016.

How many awards were anticipated in the listing?

The provided information indicates an anticipated total of two awards.

Is the maximum award amount (award ceiling) provided?

No. The award ceiling is not listed in the provided text.

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