Small-Cell Lung Cancer (SCLC) Consortium: Therapeutic Development and Mechanisms of Resistance (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is PAR-16-049?

PAR-16-049 is an NIH funding opportunity titled "The Small-Cell Lung Cancer (SCLC) Consortium: Therapeutic Development and Mechanisms of Resistance (U01)." It is designed to build and support coordinated research teams focused on small-cell lung cancer, with an emphasis on developing better treatments and understanding why resistance to therapy emerges so rapidly.

Which NIH mechanism does this opportunity use?

This opportunity uses the U01 cooperative agreement mechanism. A U01 indicates that funded projects are expected to operate with substantial NIH programmatic involvement and to participate as part of a broader consortium effort rather than functioning purely as stand-alone investigator-initiated grants.

What is the main purpose of this SCLC consortium program?

The program targets a central clinical challenge in small-cell lung cancer: although SCLC can respond initially to therapy, it often relapses quickly and becomes resistant to treatment. The FOA supports collaborative projects intended to accelerate therapeutic development and to explain, at a mechanistic level, how resistance to drugs and radiation arises and how it might be overcome.

What are the major scientific thrusts of the FOA?

The FOA is organized around two main thrusts: (1) improving SCLC therapeutics by identifying and exploiting molecular vulnerabilities in SCLC, with an emphasis on targeted approaches and rational combinations of agents; and (2) deepening understanding of the mechanisms that drive rapid clinical resistance to both drug therapy and radiation therapy, including the cellular and molecular changes that accompany resistance and how that knowledge can support more durable treatments.

Does this opportunity emphasize combination therapies or single-agent approaches?

Based on the description provided, the FOA places emphasis on targeted treatment approaches that may involve rational combinations of agents rather than single drugs used in isolation. The intent is to develop strategies informed by tumor biology, such as pairing agents to address complementary pathways, prevent escape routes, or exploit dependencies unique to SCLC.

What does "mechanisms of resistance" mean in the context of this FOA?

In this FOA, "mechanisms of resistance" refers to understanding how and why SCLC becomes resistant to treatment after an initial response. This includes investigating how resistance arises, what cellular or molecular changes occur during or after therapy, and how those insights can be translated into approaches that reduce, delay, or overcome resistance.

Is radiation resistance included, or only drug resistance?

Both are included. The FOA explicitly calls for work that addresses resistance to drug therapy and resistance to radiation therapy, reflecting the clinical reality that SCLC can rapidly develop resistance across treatment modalities.

What makes this a consortium-style opportunity?

This FOA is intended to support coordinated research teams operating as part of a consortium. In a consortium model, awardees are expected to coordinate with NIH and with each other around shared goals and collaborative activities, which can include alignment on common priorities, coordination that reduces duplication, and cross-team problem solving related to complex issues like tumor heterogeneity and therapy resistance.

How is a U01 cooperative agreement different from a standard research grant?

Based on the provided information, a cooperative agreement (U01) generally involves substantial NIH programmatic involvement. That typically means the work is conducted within a structured program where coordination with NIH and other awardees is expected, rather than operating as a completely independent project.

What types of applicants are eligible to apply?

Eligibility is broad and includes: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations. The FOA also references an "Others" category with additional eligibility details described in the full announcement.

Are industry or for-profit entities allowed to apply?

Yes. The eligibility list includes for-profit organizations (other than small businesses) and also separately includes small businesses, indicating that industry-capable partners can be eligible participants or applicants under the FOA.

Does the FOA appear designed for multidisciplinary teams?

Yes. The broad eligibility and the consortium model indicate an intent to assemble multidisciplinary teams spanning academic labs, clinical research groups, government-affiliated entities, and industry-capable partners, particularly where therapeutic development and resistance modeling benefit from diverse expertise and infrastructure.

Which federal agency and department sponsor this opportunity?

The opportunity is under the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH11).

What CFDA numbers are associated with this FOA?

The FOA is associated with CFDA numbers 93.393 and 93.394, which correspond to NIH cancer-related assistance programs.

When was the FOA created and posted?

The FOA was created and posted on December 7, 2015.

What was the listed application closing date?

The listed application closing date was November 17, 2018.

What is the award ceiling for this opportunity?

The award ceiling is listed as $450,000. The provided information notes that applicants typically need to confirm in the full FOA whether this ceiling refers to direct costs per year, total costs, or another budget structure as specified by the announcement’s terms.

How many awards were expected to be made?

The expected number of awards is not specified in the provided data. This suggests the number of funded projects may have depended on appropriations, application volume, and merit review outcomes.

What kinds of research outcomes is the FOA trying to accelerate?

The FOA is aimed at sharpening the pipeline of new therapeutic strategies for SCLC and producing mechanistic explanations for rapid resistance to drugs and radiation. The consortium structure is intended to speed translation and generate findings that are more immediately actionable for improving patient outcomes.

Why does the FOA focus so heavily on resistance in SCLC?

Small-cell lung cancer is described as aggressive, prone to early spread, and often initially responsive to therapy followed by fast relapse and treatment resistance. Resistance is presented as a major reason outcomes remain poor, making it a central focus of this program.

Does the FOA indicate a preference for biologically informed strategies?

Yes. The therapeutic development thrust emphasizes strategies informed by tumor biology, including identifying molecular vulnerabilities and using rational combinations to target complementary pathways, block escape routes, or exploit SCLC-specific dependencies.

Is this opportunity primarily basic science, translational science, or both?

Based on the provided description, it supports work that connects molecular understanding (mechanisms of resistance and vulnerabilities) to therapeutic strategy (development of new targeted and combination approaches), which implies an intent to bridge mechanistic research and therapeutic development within a coordinated consortium setting.

What is the central clinical problem the FOA is trying to solve?

The central clinical problem highlighted is that SCLC often responds at first but then relapses quickly with resistance to drugs and radiation. The FOA supports projects intended to develop better therapies and explain and address the rapid onset of resistance.