Spots Global Cancer Trial Database for Evaluation of Canakinumab in High-Risk Former-Smokers

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Trial Identification

Brief Title: Evaluation of Canakinumab in High-Risk Former-Smokers

Official Title: Molecular Studies of Canakinumab in High-Risk Former-Smokers (CANIFS)

Study ID: NCT06038526

Conditions

Cigarette Smoking-Related Carcinoma

Lung Carcinoma

Interventions

Biospecimen Collection

Bronchoscopy

Canakinumab

Carbon Monoxide Measurement

Survey Administration

Study Description

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.

Detailed Description: PRIMARY OBJECTIVE: I. To compare baseline bronchoscopy biospecimens with samples approximately 70 days after administration of canakinumab (2 doses, approximately 14 days apart) in healthy former smokers. SECONDARY OBJECTIVE: I. Determine the impact of IL-1beta inhibition on downstream inflammatory pathways. OUTLINE: Patients undergo bronchoscopy over 30-60 minutes on day 7 and receive canakinumab subcutaneously (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 carbon monoxide (CO testing on study).