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Evaluation of Canakinumab in High-Risk Former-Smokers

NCT06038526 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-05-20

No results posted yet for this 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.

Conditions

  • Cigarette Smoking-Related Carcinoma
  • Lung Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo buccal, nasal, and blood sample collection

PROCEDURE

Bronchoscopy

Undergo bronchoscopy

BIOLOGICAL

Canakinumab

Given SC

PROCEDURE

Carbon Monoxide Measurement

Undergo CO testing

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

  • Peter Shields

    lead OTHER

Principal Investigators

  • Peter G Shields, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
73 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2026-07-30
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06038526 on ClinicalTrials.gov