The National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), under the Department of Health and Human Services, intends to release a Notice of Funding Opportunity (NOFO) in the summer of 2025. This initiative seeks applications for the establishment or maintenance of Lead Academic Organizations (LAOs) as part of the Experimental Therapeutics Clinical Trials Network (ETCTN). The opportunity is issued as a forecast under the funding opportunity number FOR-CA-25-089 and is classified as a discretionary cooperative agreement under the UM1 Clinical Trial Required activity code.
The purpose of this funding is to support LAOs in designing, developing, monitoring, conducting, and analyzing early-phase clinical trials. These trials will involve experimental therapeutic agents under New Investigational Drug (IND) applications for which the NCI's Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP), holds regulatory sponsorship. LAOs are expected to engage not only in trials they lead but also in those led by other organizations within the ETCTN network.
In addition to conducting trials, each LAO will oversee scientific, programmatic, financial, and administrative aspects for participating sites. Another critical component of the role includes providing mentorship to early-career investigators, fostering the development of future leaders in clinical trial research. The use of the ETCTN Pharmacokinetic (PK) Resource Laboratory is mandatory for all LAOs to conduct pharmacokinetic studies, analyze drug interactions, pharmacodynamics, and related factors. This laboratory is funded through a separate opportunity (RFA-CA-25-027).
Currently, applications are not being accepted; this forecast serves to give potential applicants ample preparation time to form collaborations and develop responsive proposals. The official NOFO is projected to be released by July 31, 2025, with an expected application due date of October 30, 2025. Awards are anticipated to be announced by July 1, 2026, with the project start date set for the same day. The total estimated program funding is $12 million, and approximately six awards are expected.
Eligible applicants include private institutions of higher education, public and state-controlled institutions of higher education, and nonprofit organizations with 501(c)(3) status. Interested parties are encouraged to begin preparing in advance. For further details or inquiries, applicants may contact Lori A. Henderson, Ph.D., at the NCI by phone at 240-276-5930 or via email at NCIETCTNRFA@mail.nih.gov.
