The Department of Defense (DoD) is offering the Lung Cancer Clinical Translational Research Partnership Award to accelerate promising lung cancer research into clinical applications.

The FY22 LCRP Clinical Translational Research Partnership Award mechanism supports partnerships between clinicians and research scientists that will accelerate the movement of promising ideas in lung cancer into clinical applications. This award supports the development of translational research collaborations between two independent, faculty-level (or equivalent) investigators to address a critical problem or question in lung cancer in a manner that would be less readily achievable through separate efforts. Research applications only in the area of mesothelioma will not be accepted. One partner in the collaboration must be a research scientist and the other must be a clinician. In addition, one partner in the collaboration is strongly encouraged to be an active duty Service Member or federal employee from a Department of Defense (DOD) military treatment facility or laboratory, or a Department of Veterans Affairs (VA) medical center or research laboratory. It should be clear that both have had equal intellectual input into the design of the research project. Multi-institutional partnerships are encouraged but not required. At least one member of the partnership must have experience either in lung cancer research or lung cancer patient care. A proposed project in which the clinical partner merely supplies tissue samples or access to patients will not meet the intent of this award mechanism.

This mechanism is intended to support a pilot, proof-of-principle, or early-phase clinical trial and associated correlative science. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of interventions on biomedical or behavioral health-related outcomes. It is expected that the proposed trial will have a well-developed rationale, strong preliminary data, trial methodology, and execution plan. Any proposed preclinical studies in addition to the trial should be appropriately justified as to its necessity to inform and interpret trial results and the correlative science. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) submission, applications must demonstrate availability of, and access to, clinical reagents (e.g., therapeutic molecules) and patient population(s).

Consumer advocate involvement in the application is strongly encouraged. As part of the research team, the consumer advocate would assist in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. As a lay representative, the consumer advocate should be an individual who has been diagnosed with lung cancer and is active in a lung cancer advocacy organization. The consumer advocate role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, lung cancer.

The success of the project must be supported by the unique skills and contributions of each partner. The proposed study must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved. The plans must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award.

Preliminary lung cancer relevant data to support the feasibility of the research hypotheses and research approaches are required. Clinical trials are supported by this award mechanism and require the submission of Attachment 8, Regulatory Strategy.

Relevance to Military Health: The LCRP seeks to support research that is relevant to the healthcare needs of military Service Members, Veterans, and their families. Relevance to military health will be considered in determining relevance to the mission of the DHP and FY22 LCRP during programmatic review. Investigators are strongly encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:

Use of military or Veteran populations, biospecimens, data/databases, or programs in the proposed research.

• Collaboration with DOD or VA investigators.

• Explanation of how the project addresses an aspect of lung cancer that has relevance or is unique to the military, Veterans, other Military Health System

(MHS) beneficiaries, or family readiness of Service Members, including environmental exposures other than tobacco.

The Clinical Translational Research Partnership Award mechanism requires two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as the Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PIs refer to Section II.D.2, Content and Form of the Application Submission.

The FY22 LCRP Clinical Translational Research Partnership Award mechanism supports partnerships between clinicians and research scientists that will accelerate the movement of promising ideas in lung cancer into clinical applications. This award supports the development of translational research collaborations between two independent, faculty-level (or equivalent) investigators to address a critical problem or question in lung cancer in a manner that would be less readily achievable through separate efforts. Research applications only in the area of mesothelioma will not be accepted. One partner in the collaboration must be a research scientist and the other must be a clinician. In addition, one partner in the collaboration is strongly encouraged to be an active duty Service Member or federal employee from a Department of Defense (DOD) military treatment facility or laboratory, or a Department of Veterans Affairs (VA) medical center or research laboratory. It should be clear that both have had equal intellectual input into the design of the research project. Multi-institutional partnerships are encouraged but not required. At least one member of the partnership must have experience either in lung cancer research or lung cancer patient care. A proposed project in which the clinical partner merely supplies tissue samples or access to patients will not meet the intent of this award mechanism.

This mechanism is intended to support a pilot, proof-of-principle, or early-phase clinical trial and associated correlative science. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of interventions on biomedical or behavioral health-related outcomes. It is expected that the proposed trial will have a well-developed rationale, strong preliminary data, trial methodology, and execution plan. Any proposed preclinical studies in addition to the trial should be appropriately justified as to its necessity to inform and interpret trial results and the correlative science. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) submission, applications must demonstrate availability of, and access to, clinical reagents (e.g., therapeutic molecules) and patient population(s).

Consumer advocate involvement in the application is strongly encouraged. As part of the research team, the consumer advocate would assist in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. As a lay representative, the consumer advocate should be an individual who has been diagnosed with lung cancer and is active in a lung cancer advocacy organization. The consumer advocate role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, lung cancer.

The success of the project must be supported by the unique skills and contributions of each partner. The proposed study must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved. The plans must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award.

Preliminary lung cancer relevant data to support the feasibility of the research hypotheses and research approaches are required. Clinical trials are supported by this award mechanism and require the submission of Attachment 8, Regulatory Strategy.

Relevance to Military Health: The LCRP seeks to support research that is relevant to the healthcare needs of military Service Members, Veterans, and their families. Relevance to military health will be considered in determining relevance to the mission of the DHP and FY22 LCRP during programmatic review. Investigators are strongly encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:

Use of military or Veteran populations, biospecimens, data/databases, or programs in the proposed research.

• Collaboration with DOD or VA investigators.

• Explanation of how the project addresses an aspect of lung cancer that has relevance or is unique to the military, Veterans, other Military Health System

(MHS) beneficiaries, or family readiness of Service Members, including environmental exposures other than tobacco.

The Clinical Translational Research Partnership Award mechanism requires two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as the Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PIs refer to Section II.D.2, Content and Form of the Application Submission.