Evaluation of Canakinumab in High-Risk Former-Smokers

NCT06038526 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-22297NCI-2023-05942
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Change in ASCs (apoptosis-associated speck-like protein containing a caspase activation and recruitment domain)

  Will be assessed by a generalized linear mixed model (GLM) and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.

  At baseline and day 77

• Change in caspase-1

  Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.

  At baseline and day 77

• Change in interleukin-1 beta (IL-1beta)

  Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.

  At baseline and day 77

Secondary Outcomes (4)

• Changes in immune cell composition in bronchoalveolar lavage (BAL) by mass cytometry (CyTOF)

  At baseline and day 77

• Changes in cytokines in the blood

  At baseline and day 77

• Changes in BAL

  At baseline and day 77

• Bronchoscopy for fractional concentration of exhaled nitric oxide (FeNO)

  At baseline and day 77

Study Arms (1)

Prevention (canakinumab, bronchoscopy)

EXPERIMENTAL

Patients undergo bronchoscopy over 30-60 minutes and receive canakinumab SC 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and CO testing on study.

Procedure: Biospecimen Collection; Procedure: Bronchoscopy; Biological: Canakinumab; Procedure: Carbon Monoxide Measurement; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo buccal, nasal, and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Prevention (canakinumab, bronchoscopy)

Bronchoscopy PROCEDURE

Undergo bronchoscopy

Prevention (canakinumab, bronchoscopy)

Canakinumab BIOLOGICAL

Given SC

Also known as: ACZ885, Ilaris

Prevention (canakinumab, bronchoscopy)

Carbon Monoxide Measurement PROCEDURE

Undergo CO testing

Also known as: Carbon Monoxide, CO

Prevention (canakinumab, bronchoscopy)

Survey Administration OTHER

Ancillary studies

Prevention (canakinumab, bronchoscopy)

Eligibility Criteria

• Age: 40 Years - 73 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Smoked tobacco or cannabis within 3 years of enrollment (target study population is former smokers) Used an electronic cigarette or vaped including THC within 3 years of enrollment (impacts biomarkers)3 CO \> 8ppm (target study population is former smokers) History of or recent exposure to tuberculosis (TB) as documented in the EMR and/or testing (impacts risk) BMI \> 45 (risk of unstable airway)
• Taking ASA or NSAIDs daily or most days per week (impacts biomarkers and risk)
• Concomitant diseases and life-threatening conditions (e.g., cancer or kidney, liver, immune system disorders)
• Prior diagnosis of chronic pulmonary disease that requires regular use of inhalers or medications that influence biomarkers (e.g., asthma, chronic bronchitis, and restrictive lung disease) (impacts biomarkers and risk)
• Acute bronchitis or pneumonia within 1 year (impacts biomarkers)
• COVID-19 diagnosis or related symptoms within the last 3 months (impacts biomarkers and risk)
• General anesthesia within 3 months (impacts biomarkers)
• Regular use of inhalant medications in the last 3 months (impacts biomarkers)
• Use of antibiotics in prior 30 days (impacts biomarkers)
• Use of steroids, including corticosteroids and inhaled corticosteroids, in prior 30 days (impacts biomarkers)
• Use of prohibited concomitant therapy including but not limited to immunosuppressants (impacts biomarkers and risk)4
• Live or attenuated vaccines within 90 days of study treatment and after initiation of study drug (impacts biomarkers and risk)5
• Allergies to study medications, such as, lidocaine, Versed, Fentanyl or Cetacaine (impacts risk)
• Bronchoscopy or any other lung procedure for any reason within the previous 6 months (impacts biomarkers)
• Current or recent (within three months) alcohol or drug abuse problems (impacts risk)

Sponsors & Collaborators

• Peter Shields: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The James line

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Specimen Handling; Bronchoscopy; canakinumab; Carbon Monoxide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Diagnostic Techniques, Respiratory System; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• Peter G Shields, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 14, 2023
• Study Start: March 11, 2024
• Primary Completion: February 4, 2026
• Study Completion: May 26, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)