Notice of Intent to Publish a Funding Opportunity Announcement for National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)

Key Dates

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National Cancer Institute (NCI)

The National Cancer Institute (NCI) intends to reissue the NCI's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required) Notice of Funding Opportunity (NOFO), which will support research projects that propose early phase (Phase 0, I, and II) investigator-initiated clinical trials focused on cancer-targeted diagnostic and therapeutic interventions of direct relevance to the research mission of the NCI’s Division of Cancer Treatment and Diagnosis (DCTD), and the Office of HIV and AIDS Malignancies (OHAM, Office of the Director).  Interested applicants are strongly encouraged to consult the NCI DCTD website and/or the OHAM website to learn more about the various program goals, research priorities, and strategies developed to fight cancer. The NOFO is a re-issuance of PAR-21-033.

This Notice of Intent to Publish (NOITP) is being provided to allow sufficient time for the applicants to develop strong applications. The NOFO is expected to be published in late fall 2023 with an expected first application due date in late winter 2024. 

This NOFO will be applicable to a broad range of clinical trial evaluations designed to improve the diagnosis and treatment of cancer in areas of common and unmet need. An individual application is expected to represent the applicant's or applicants' interest(s) and competencies, as well as the science related to the diagnosis and treatment of cancer patients conducted through well-designed and executed clinical trials. The research may include the development of therapeutics, diagnostics, and devices alone or in combination with standard of care therapies, including chemotherapy, immunotherapy, surgery, radiotherapy, or any combination of these modalities.

Areas of research may include, but are not limited to, the clinical evaluation of:

• new or improved anticancer drugs and biologics, including immunotherapies;
• new or improved imaging technologies and surgical interventions;
• novel approaches to radiation therapy; and
• incorporation of complementary and alternative medicine approaches to treatment.

All applications must include a clinical trial to be responsive to this NOFO. Trials proposed must meet the NIH definition of a clinical trial (see NOT-OD-15-015) and should contribute to the advancement of evidence-based medicine/practice and the sciences that support it.

Non-responsive applications: This NOFO will not support: 

• A phase III clinical trial;
• Only animal and/or in vitro studies that do not complement a trial;
• Observational studies (do not meet the NIH definition of a clinical trial);
• Behavioral interventions without a therapeutic endpoint as an objective;
• Clinical trials that are to be performed by NCI-funded networks and special programs (e.g., ETCTN, NCTN, and Specialized Programs of Research Excellence (SPOREs).

These applications will be deemed not responsive to this NOFO and will not be reviewed.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

For Therapeutic Studies:
Lori A. Henderson, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5930
Email: hendersonlori@mail.nih.gov

For Imaging Studies:
Lalitha Shankar, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5936
Email: ls419z@nih.gov

For Radiation Research Studies:
Jeff Buchsbaum, M.D., Ph.D., AM
National Cancer Institute (NCI)
Telephone: 240-276-5914
Email: jeff.buchsbaum@nih.gov

For Biomarker Studies:
Tracy G. Lively, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5944
Email: livelyt@mail.nih.gov

For Complementary and Alternative Medicine Studies:
Dan Xi, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6143
E-mail: xida@mail.nih.gov

For HIV and AIDS Studies:
Rebecca Liddell Huppi, Ph.D.
National Cancer Institute
Telephone: 240-781-3324
Email: liddellr@exchange.nih.gov