Evaluation of Canakinumab in High-Risk Former-Smokers (NCT06038526) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Evaluation of Canakinumab in High-Risk Former-Smokers
United States41 participantsStarted 2024-03-11
Plain-language 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.
Who can participate
Age range
40 Years – 73 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 exclusion 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
Exclusion Criteria
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 influ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing canakinumab in high-risk former smokers to see how it affects specific inflammatory markers like IL-1beta and caspase-1 — does my own inflammatory profile or smoking history make this kind of approach worth discussing for me?
2Since this is a Phase 2 trial, what do we actually know so far about how safe canakinumab is for people like me, and what side effects should I be most aware of given that it works by suppressing part of the immune system?
3The trial is no longer enrolling new participants — does that mean results might be available soon, and could those findings change what treatment or monitoring options you'd recommend for me?
4The study is measuring changes in biological markers like ASCs and IL-1beta rather than direct cancer outcomes — what would a positive result in those markers actually mean for my personal risk of developing lung cancer?
5Before considering something like this, is there a standard surveillance or prevention strategy for high-risk former smokers that I should be following first, and how would this trial's approach compare to that?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in ASCs (apoptosis-associated speck-like protein containing a caspase activation and recruitment domain)