DoD Lung Cancer Clinical Exploration Award

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The LCRP Clinical Exploration Award (CEA) mechanism was first offered in FY13. Since then, 12 CEA applications have been received, and 2 have been recommended for funding.This award mechanism supports early-phase, proof-of-principle clinical trials and correlative studies to investigate hypothesis-based, innovative interventions that have the potential to resolve current clinical barriers and result in a profound impact on the clinical management of lung DoD FY14 Lung Cancer Clinical Exploration Award 4cancer. While therapeutic approaches proposed for testing through the CEA must represent novel, hypothesis-based, “outside-the-box” approaches for treating lung cancer, they may include therapies already in clinical use, or undergoing clinical testing, for other diseases, provided that the proposed use for lung cancer would lead to a major advancement for treating the disease. It is anticipated that outcomes from studies funded by this award will provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform lung cancer clinical care. Submissions from and partnerships with investigators at Military Treatment Facilities (MTFs), military labs, the Department of Veterans Affairs (VA) Medical Centers and research laboratories are strongly encouraged.The CEA supports clinical trials encompassing Phase 0, Phase I, or pilot Phase II for drug or drug combinations, Class II or III devices, or other types of trials that conduct early clinical testing of innovative approaches for lung cancer. Information on clinical trials and phases/classes of study is provided in the “Human Subject Resource Document” available for download from eBRAP at https://ebrap.org/eBRAP/public/Program.htm.Correlative Studies Category (New for FY14): The CEA-Correlative Studies category supports innovative, hypothesis-based, correlative studies that derive from ongoing or completed clinical trials supported by other funding sources. These correlative studies, if successful, will have the potential to significantly inform treatment strategies, identify subsets of patients for treatment with specific therapies, provide increased understanding of biological changes resulting from the intervention in lung cancer, or provide other insight that will significantly enhance clinical management of lung cancer. Examples of correlative studies appropriate for submission to the CEA-Correlative Studies category may include, but are not limited to:• Analysis of biomarkers for prognosis and/or prediction or assessment of therapeutic response or progression;• Investigations of the mechanism of action or the development of resistance to a drug;• Analysis of immune response or factors associated with progression;• Characterization of tumor antigens for the development of new improved therapies.Applications proposing correlative studies will be peer- and programmatically reviewed separately from those proposing clinical trials.Funding from the CEA must support a clinical trial or correlative study associated with an ongoing or completed clinical trial and cannot be used for preclinical research studies.

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