DoD Lung Cancer Clinical Exploration Award | Apply Online

FAQs: DoD Lung Cancer Clinical Exploration Award (CEA)

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 that is intended to move promising ideas into early clinical testing. It supports hypothesis-driven, "proof of principle" clinical work designed to address real-world barriers in lung cancer care and generate interpretable clinical signals that can justify later-stage efficacy trials.

What is the primary goal of this award?

The central goal is clinical exploration, not definitive proof of efficacy. The program prioritizes innovative interventions with a credible chance of changing how lung cancer patients are managed, and it expects a strong scientific rationale, a clearly articulated hypothesis, and an efficient trial design that can guide next-step development decisions.

What types of studies does the CEA support?

The CEA primarily supports early-phase clinical trials, including Phase 0, Phase I, and pilot Phase II studies. It can also support other early clinical testing approaches that represent clinical exploration of new lung cancer strategies.

Which clinical trial phases are specifically emphasized?

The opportunity emphasizes Phase 0, Phase I, and pilot Phase II clinical studies. Applicants are directed to consult DoD human subjects guidance materials (available through eBRAP) for definitions and expectations related to trial phases and classifications.

Can the award fund studies involving drugs or drug combinations?

Yes. The award can fund trials of drugs and drug combinations as part of early clinical testing of new strategies in lung cancer.

Can the award fund studies involving medical devices?

Yes. The announcement notes support for studies involving Class II or Class III medical devices, as long as the work fits the program focus on early clinical testing in lung cancer.

Does the intervention have to be completely new to medicine?

No. The approach being tested must be novel in the lung cancer setting, but the intervention itself does not need to be entirely new. For example, therapies already used or being tested in other diseases may be proposed if their application in lung cancer represents a major step forward.

What does the program mean by "proof of principle" and "clinical signals"?

Within the context of this announcement, "proof of principle" refers to hypothesis-driven early clinical work intended to produce interpretable results (clinical signals) that help determine whether a strategy is promising enough to justify larger, later-stage efficacy testing.

Does the CEA support broad or incremental studies?

No. The program description indicates that it is not intended to fund broad or incremental studies. Instead, it emphasizes innovative, outside-the-box interventions that can overcome real-world barriers in lung cancer care and provide clear justification for follow-on development.

What is the Correlative Studies Category?

The Correlative Studies Category (added for FY14) supports hypothesis-based correlative research that leverages ongoing or completed clinical trials funded through other sources. The purpose is to extract clinically meaningful insights from those trials, such as refining treatment strategies, identifying patient subsets most likely to benefit, and understanding biological responses to interventions.

Are correlative studies reviewed the same way as interventional clinical trials?

No. Correlative studies are reviewed separately from interventional clinical trial proposals, reflecting that they have distinct aims and evaluation criteria.

What are examples of research topics considered appropriate for correlative studies?

Examples listed in the opportunity include biomarker analyses for prognosis or treatment response, studies of a drug's mechanism of action and resistance pathways, immune monitoring tied to outcomes or progression, and tumor antigen characterization to inform improved therapies.

Can CEA funding be used for preclinical research?

No. The announcement includes a key restriction: CEA funds must be used for a clinical trial or an eligible correlative study tied to an existing trial, and they cannot be used to support preclinical research.

Is collaboration with DoD or federal healthcare research environments encouraged?

Yes. The opportunity strongly encourages involvement from or collaboration with Department of Defense and federal healthcare research environments, including Military Treatment Facilities, military laboratories, and Department of Veterans Affairs (VA) medical centers and research laboratories.

Why does the opportunity encourage DoD/VA collaborations?

Based on the program description, the intent is to build partnerships that can accelerate translation and broaden access to clinical research infrastructure serving military members, veterans, and the wider patient population.

Who offered this FY14 funding opportunity?

This FY14 opportunity was offered by the Department of the Army (USAMRAA) through the Congressionally Directed Medical Research Programs (CDMRP).

When was the opportunity posted and when did it close?

It was posted on April 14, 2014, and the application closing date was September 17, 2014. The archive date listed is October 17, 2014.

What funding mechanism was listed for this award?

The funding instrument is listed as a cooperative agreement and grant.

How many awards were anticipated and what was the estimated total funding?

The announcement anticipated four awards, with an estimated total funding amount of $2,240,000.

Who was eligible to apply?

Eligibility is described as unrestricted, meaning it was open to any type of entity, as stated in the opportunity summary.

Was cost sharing or matching required?

No. The opportunity summary states that there is no cost-sharing or matching requirement.

What CFDA number is associated with this opportunity?

The listed CFDA number is 12.420, Military Medical Research and Development.

Where were applicants directed for human subjects and trial phase guidance?

Applicants were directed to DoD human subjects guidance materials available through eBRAP for definitions and expectations related to trial phases and study classifications.

How could applicants get help accessing the announcement?

Applicants were directed to contact the CDMRP help desk at 301-682-5507 or by email at help@eBRAP.org.