Evaluation of Canakinumab in High-Risk Former-Smokers

Conditions

• Cigarette Smoking-Related Carcinoma
• Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

40 Years - 73 Years

Healthy Volunteers

Accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo buccal, nasal, and blood sample collection
• Bronchoscopy — PROCEDURE
  Undergo bronchoscopy
• Canakinumab — BIOLOGICAL
  Given SC
• Carbon Monoxide Measurement — PROCEDURE
  Undergo CO testing
• Survey Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Mar 11, 2024

Status verified

May 2026

Primary completion

Jul 30, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

41 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Prevention (canakinumab, bronchoscopy)
  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.

Primary Outcome Measure

Change in ASCs (apoptosis-associated speck-like protein containing a caspase activation and recruitment domain) [ Time Frame: At baseline and day 77 ]

Locations (1)

Find similar trials in Columbus, OH

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