Evaluation of Canakinumab in High-Risk Former-Smokers

Study summary

This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving canakinumab may block the inflammatory system and could have positive effects to reduce cancer growth.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedBiospecimen Collection and Bronchoscopy

Plus 3 other study approaches.

Who it may be forCigarette Smoking-Related Carcinoma · Lung Carcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 7, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Peter Shields

Study sponsor

Study overview

What this study is about

Purpose: Prevention
Study type: Interventional
Phase: Phase 2
Sponsor: Peter Shields
Interventions being studied: Procedure: Biospecimen Collection; Procedure: Bronchoscopy; Biological: Canakinumab; Procedure: Carbon Monoxide Measurement; Other: Survey Administration

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Eligibility Criteria Age 40-73 (age criteria aligns with CANTOS trial) If female: evidence of post-menopausal status1 or negative urinary or serum pregnancy test (unknown impact on pregnancy) Former smoker with no use in ≥ 3 years prior to enrollment (targets former smoker population) CO ≤ 8ppm (targets/confirms former smoker population) Pack-years history of ≥ 20 (defined as high risk) No unstable or significant medical conditions as determined by medical history (see

Reasons someone may not be able to joinExclusion criteria

below - to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures) Negative COVID-19 test (if applicable)2 Able to read adequately to complete the survey and related study documents or give consent

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Ohio State University Comprehensive Cancer CenterColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 7, 2026. Always confirm current availability with the study team.

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