Canakinumab for Lung Cancer Risk Reduction in Former-Smokers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether canakinumab can reduce lung cancer risk in former smokers by blocking inflammation, potentially slowing cancer growth. Canakinumab targets a protein involved in inflammation. Participants stopped smoking at least five years ago, have a history of heavy smoking (30 pack-years or more), and exhibit higher-than-normal inflammation levels. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications, such as daily aspirin, NSAIDs, immunosuppressants, and some steroids, before and during the study. If you are on medications that affect the immune system, you may need to stop them for at least 130 days after the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that canakinumab is likely to be safe for humans?
Research has shown that canakinumab is generally safe for people. In earlier studies, participants taking canakinumab did not experience severe side effects. The FDA has already approved this treatment for other conditions, such as certain inflammatory diseases, indicating a known safety record. While side effects can occur, such as mild reactions at the injection site, serious side effects are rare. This trial phase focuses on safety, suggesting a good level of confidence in canakinumab's safety for participants.12345
Why do researchers think this study treatment might be promising?
Canakinumab is unique because it targets inflammation specifically through the inhibition of interleukin-1 beta, a mechanism not addressed by most current lung cancer prevention strategies. Unlike traditional treatments, which often focus on directly targeting cancer cells or preventing DNA damage, canakinumab aims to reduce the chronic inflammation that can contribute to cancer development, particularly in former smokers. Researchers are excited about this approach because it represents a novel way to tackle lung cancer risk, potentially offering an additional layer of prevention that complements existing therapies.
What evidence suggests that canakinumab might be an effective treatment for lung cancer risk reduction in former smokers?
Research has shown that canakinumab, which participants in this trial will receive, might help lower the risk of lung cancer in former smokers. One study found no new cases of lung cancer in a group of high-risk patients during the first six months of treatment with canakinumab. This treatment blocks a protein called interleukin-1 beta (IL-1b), which can cause inflammation. Reducing inflammation is believed to slow cancer growth. Although more research is needed, these findings suggest that canakinumab could be promising for preventing lung cancer.24678
Who Is on the Research Team?
Peter G. Shields, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for former smokers aged 55-73 with a history of heavy smoking (30+ pack-years) and high inflammation markers (hsCRP >= 2 mg/L). Participants must not have smoked or used tobacco/vaping products in the last five years. Women should be post-menopausal, on contraception, or sterilized. People with unstable medical conditions, recent serious infections like COVID-19, or those taking certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive canakinumab subcutaneously and undergo bronchoscopy and sample collection
Follow-up
Participants are monitored for changes in immune cell composition and inflammatory markers
What Are the Treatments Tested in This Trial?
Interventions
- Canakinumab
Canakinumab is already approved in European Union, United States for the following indications:
- Cryopyrin-Associated Periodic Syndromes (CAPS)
- Familial Cold Autoinflammatory Syndrome (FCAS)
- Muckle-Wells Syndrome (MWS)
- Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)
- Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
- Familial Mediterranean Fever (FMF)
- Systemic Juvenile Idiopathic Arthritis (SJIA)
- Adult-Onset Still's Disease (AOSD)
- Cryopyrin-Associated Periodic Syndromes (CAPS)
- Familial Cold Autoinflammatory Syndrome (FCAS)
- Muckle-Wells Syndrome (MWS)
- Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)
- Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
- Familial Mediterranean Fever (FMF)
- Systemic Juvenile Idiopathic Arthritis (SJIA)
- Adult-Onset Still's Disease (AOSD)
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Who Is Running the Clinical Trial?
Peter Shields
Lead Sponsor