Small-Cell Lung Cancer (SCLC) Consortium: Therapeutic Development and Mechanisms of Resistance (U01 Clinical Trial Not Allowed) | PAR 19 361

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This is a National Institutes of Health (NIH) funding opportunity issued through the National Cancer Institute (NCI) to support cooperative agreement applications (U01) that will form research teams within the Small-Cell Lung Cancer (SCLC) Consortium.

What is the main goal of the program?

The central goal is to speed up progress on treatments for small-cell lung cancer by funding coordinated, team-based research that can directly inform future therapeutic strategies.

What scientific focus areas does the FOA prioritize?

The FOA concentrates on two research areas: (1) therapeutic development by identifying and exploiting molecular vulnerabilities in SCLC to enable improved targeted therapies (including rational drug combinations), and (2) mechanistic studies explaining why SCLC rapidly develops resistance to treatment, including resistance to both drug therapies and radiation.

Are clinical trials allowed under this announcement?

No. Clinical trials are not allowed under this announcement. The emphasis is on preclinical, translational, and mechanistic work that can guide or enable future therapeutic approaches, rather than testing interventions in patients under this specific award.

How does this FOA relate to the NCI 2014 Scientific Framework for SCLC?

Alignment with the NCI 2014 Scientific Framework for SCLC is a central theme. While the framework outlined five broad research priorities, this FOA focuses specifically on therapeutic development and mechanisms of resistance. Applicants are also expected to integrate other framework priorities as appropriate, especially through use of modern tools and comprehensive molecular characterization.

What types of data and research approaches are expected?

Projects are expected to use state-of-the-art tools and comprehensive molecular characterization. In practice, that includes leveraging or generating high-quality "omics" datasets (for example genomic, transcriptomic, epigenomic, proteomic, or other profiling approaches) and using advanced model systems to ensure findings reflect human SCLC biology.

Why is the FOA emphasizing advanced model systems and disease evolution?

The FOA highlights the importance of biological and clinical relevance, including understanding how SCLC changes over time, spreads, and adapts under treatment pressure. Advanced models and deep molecular profiling are intended to make discoveries more applicable to real-world SCLC behavior and resistance.

What does it mean that this is a consortium-based program?

Awardees are expected to operate as well-defined research teams that function as part of a larger consortium rather than as isolated projects. The program is designed to produce shared tools, interoperable datasets, and collectively validated insights, not only individual lab outputs.

What collaboration expectations are described?

Funded teams are expected to collaborate actively with one another and with a dedicated SCLC Coordinating Center. This structure is intended to align scientific priorities, promote sharing of data and resources, and increase consistency across projects.

What is the role of the SCLC Coordinating Center?

The Coordinating Center is described as a dedicated component intended to help align scientific priorities across the consortium, promote data and resource sharing, and improve consistency across projects so results can be compared and validated more effectively.

How does this FOA fit into the broader SCLC Consortium?

This FOA is centered on therapeutics and resistance. The overall consortium is described as having a third component focused on prevention and early detection, indicating a broader, multi-pronged national strategy for SCLC even though this particular funding call targets treatment development and resistance biology.

What kinds of projects are likely to be a good fit?

Projects likely to fit well include those with a strong molecular rationale, sophisticated profiling and/or functional approaches, clinically relevant SCLC models, and a clear plan for consortium-oriented data and resource sharing so findings can be compared, reproduced, and translated into better treatment concepts.

What is the funding mechanism and what does "cooperative agreement" imply?

The mechanism is a cooperative agreement (U01). This implies NIH expects substantial programmatic involvement compared with a standard research project grant, consistent with the coordinated consortium structure and shared deliverables.

What is the opportunity number?

The opportunity number is PAR-19-361.

Which NIH institute is leading this opportunity?

The opportunity is offered by NIH through the National Cancer Institute (NCI).

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.393, 93.394, and 93.396.

When was the opportunity originally posted, and what is the original closing date listed?

The original posting date is listed as August 29, 2019, and the original closing date shown is March 11, 2022.

What is the award ceiling?

The award ceiling is listed as $450,000. This indicates an upper bound on costs as defined in the full announcement, and applicants are expected to propose a scope that is feasible within that constraint while still producing consortium-relevant deliverables.

Who is eligible to apply?

Eligibility is broad and includes many domestic institutions and organizations such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and various levels of government (state, county, city/township, special districts), as well as independent school districts and public housing authorities.

Are minority-serving institutions and tribal entities eligible?

Yes. The FOA explicitly includes many minority-serving institution types (including Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, among others). Federally recognized tribal governments and tribal organizations (including those other than federally recognized governments) are also eligible.

Can non-U.S. (foreign) organizations apply?

Yes. Non-U.S. entities (foreign organizations) may apply under this opportunity, and U.S. territories or possessions and certain regional organizations are also included as eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The FOA includes faith-based or community-based organizations among eligible applicants.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are included as eligible applicants under this opportunity.

What is the practical emphasis of the research supported (given that trials are not allowed)?

The practical emphasis is on preclinical, translational, and mechanistic research that can uncover actionable vulnerabilities, guide rational combination strategies, and explain resistance mechanisms in ways that can shape future therapeutic development efforts.

What types of resistance are specifically called out?

The FOA explicitly calls out rapid resistance to treatment, including resistance to drugs and to radiation, as a major focus area for mechanistic investigation.