NIH Highlighted Topic: Advancing Precision Research for Lung Cancer in Never Smokers and Its Risk Factors

Overview

The National Institutes of Health (NIH) is encouraging precision cancer research and technology development for lung cancer in never smokers (LCINS). The goal is to identify risk factors, understand the biology, develop early detection and prevention strategies, and advance diagnosis and therapy.

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LCINS accounts for roughly 10% to 20% of U.S. lung cancers each year and is estimated to be the eighth leading cause of cancer death in the United States. Many patients are diagnosed at an advanced stage, and the disease responds differently to therapies, including immunotherapy, than smoking-associated lung cancer. Companies with diagnostic, therapeutic, or AI technology can pursue this through the NIH SBIR program.

Key dates and funding

• Next SBIR due dates: January 5, 2027 and April 5, 2027 (5:00 PM local time of your organization)
• Application route: NIH, CDC and FDA Parent SBIR (R43/R44), PA-27-100, Clinical Trial Optional
• Project period: normally up to 6 months for Phase I and up to 2 years for Phase II
• Topic window: NIH lists this Highlighted Topic through October 4, 2028, so it can support more than one submission cycle

Budget guidelines in PA-27-100 vary by participating Institute or Center. Total costs (direct, indirect, and fee) normally stay within these amounts:

• National Cancer Institute (NCI): Phase I $700,000, Phase II $2,500,000
• National Institute of Environmental Health Sciences (NIEHS): SBA guideline for both phases
• National Institute on Minority Health and Health Disparities (NIMHD): SBA guideline for both phases

Who is eligible?

Only United States small business concerns can apply through the NIH Parent SBIR announcement. In plain terms, your company must meet these requirements:

• A for-profit business with a place of business in the United States and no more than 500 employees, including affiliates
• Generally more than 50% owned and controlled by U.S. citizens or permanent residents, or by qualifying venture capital, hedge fund, or private equity owners under SBA rules
• The Principal Investigator is primarily employed by the small business at the time of award and for the duration of the project
• No foreign organizations, foreign components, or foreign subawards (unfunded foreign collaborators and foreign consultants are permitted)
• Companies selected for funding submit the SBA foreign affiliations disclosure during the Just-in-Time process

Focus areas by NIH Institute

NCI: biology, detection, and precision therapy

• Biological and environmental factors, including sex and ancestry, behind LCINS initiation and progression
• Mechanisms that distinguish LCINS biology from tobacco-associated lung cancer
• Early detection and diagnostic strategies, including biomarker development
• Mechanism-driven interventions such as overcoming therapeutic resistance, targeting rare mutations, cancer vaccines, and immunotherapies
• Human-relevant research models, databases, computational methods and AI, and other emerging technologies

NIEHS: environmental carcinogens

• New Approach Methodologies to identify chemicals and exposures that are potential lung carcinogens
• Early detection based on disease characteristics in patients exposed to known lung carcinogens

NIMHD: disparities

• Interventions to improve risk prediction, early detection biomarkers, imaging, prevention, treatment selection, and guideline-concordant care
• NIMHD may give special consideration to meritorious applications

How to apply

NIH Highlighted Topics are not funding opportunities on their own. Small businesses apply through the NIH, CDC and FDA Parent SBIR announcement (PA-27-100) and write the application to match the interests of at least one participating Institute or Center. Read the full NIH Highlighted Topic before you start.

• Register early: SAM.gov (which issues your UEI and can take six weeks or more), Grants.gov, eRA Commons (a Signing Official plus a PI account with a linked ORCID iD), and the SBA Company Registry (proof of registration is attached to the application)
• Talk to the program officer: the topic lists a central NCI contact plus NIEHS and NIMHD contacts, and ODP also participates but does not award grants
• Check the budget: contact the participating Institute or Center early if you plan to request more than the SBA budget guideline
• Submit electronically: through NIH ASSIST, a system-to-system solution, or Grants.gov Workspace by 5:00 PM local time on January 5, 2027 or April 5, 2027

Is this a fit for your company?

This topic suits companies developing liquid biopsy or other early detection assays, imaging and AI risk prediction tools, targeted therapies, cancer vaccines, or immunotherapies, including approaches to rare mutations and therapeutic resistance, and human-relevant models such as organoids. NCI's $700,000 Phase I guideline makes it the strongest target for most product companies.

If that sounds like your company, book a free funding fit call with BW&CO. Our team has helped secure $350M+ in non-dilutive funding and can tell you quickly whether this topic, and which Institute, is the right target for your January or April submission.

Frequently asked questions

Is the NIH lung cancer in never smokers Highlighted Topic a funding opportunity?

No. It is an NIH Highlighted Topic, which signals scientific interest but is not a notice of funding opportunity. Small businesses apply through the NIH Parent SBIR announcement (PA-27-100), with the next due dates on January 5, 2027 and April 5, 2027.

How much NIH SBIR funding is available for lung cancer in never smokers research?

Under PA-27-100, NCI allows up to $700,000 for Phase I and up to $2,500,000 for Phase II. NIEHS and NIMHD follow the SBA guideline.

Which NIH Institutes participate in the lung cancer in never smokers topic?

NCI, NIEHS, and NIMHD are the awarding participants. ODP also participates but does not award grants.

What research does NIH want on lung cancer in never smokers?

Risk factors and biology, early detection and diagnostic biomarkers, precision therapies including immunotherapies and cancer vaccines, environmental carcinogen identification, and human-relevant models, databases, and AI.

Who is eligible to apply through NIH SBIR?

U.S. for-profit small businesses with no more than 500 employees, majority owned and controlled by U.S. citizens or permanent residents (or qualifying investors under SBA rules), whose Principal Investigator is primarily employed by the company. Foreign organizations and foreign subawards are not allowed.

Can BW&CO help with an NIH SBIR application for this topic?

Yes. BW&CO helps small businesses choose the right NIH Institute, align the Specific Aims with the Highlighted Topic, and build a competitive SBIR application. The firm has helped clients secure $350M+ in non-dilutive funding. Book a free funding fit call to see if your technology is a match.