Canakinumab for Lung Cancer Risk Reduction in Former-Smokers

Recruiting in Palo Alto (17 mi)

Overseen by Peter G. Shields, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Peter Shields

Must not be taking: NSAIDs, Steroids, Immunosuppressants, others

Disqualifiers: Smoking, Obesity, Lung disease, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

How is the drug Canakinumab unique for reducing lung cancer risk in former smokers?

Canakinumab is unique because it is an anti-inflammatory drug that targets a specific protein called interleukin-1 beta (IL-1β), which is different from traditional lung cancer treatments like chemotherapy or immune checkpoint inhibitors that focus on attacking cancer cells directly. This approach may help reduce inflammation-related cancer risk in former smokers. ^{1 2 3 4 5}

Research Team

Peter G. Shields, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

I am between 55 and 73 years old.

I am a male sterilized at least 6 months ago, or my only partner is a vasectomized male.

I am post-menopausal or have a negative pregnancy test.

Exclusion Criteria

I am taking more than 15 mg of methotrexate weekly.

I am currently taking immunosuppressants.

I have not had COVID-19 or its symptoms in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive canakinumab subcutaneously and undergo bronchoscopy and sample collection

11 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in immune cell composition and inflammatory markers

4 weeks

Treatment Details

Interventions

• Canakinumab (Monoclonal Antibodies)

Trial Overview The trial is testing canakinumab's effects on reducing cancer growth risk by examining its impact on inflammatory biomarkers in biologic samples from high-risk former smokers. Canakinumab targets interleukin-1 beta to potentially disrupt cancer-promoting inflammation.

Participant Groups

Group I: Prevention (canakinumab, bronchoscopy) Experimental Treatment 5 Interventions

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ohio State University Comprehensive Cancer Center Columbus, OH

Who Is Running the Clinical Trial?

Peter Shields

Lead Sponsor

Trials

1

Patients Recruited

80+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Use and Response to Immune Checkpoint Inhibitor Therapy in Non-Small Cell Lung Cancer. Corke, LK., Li, JJN., Leighl, NB., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy in Non-Small Cell Lung Cancer: Facts and Hopes. Doroshow, DB., Sanmamed, MF., Hastings, K., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Smoking on Response to the First-Line Treatment of Advanced ALK-Positive Non-Small Cell Lung Cancer: A Bayesian Network Meta-Analysis. Lin, K., Lin, J., Huang, Z., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive value of oncogenic driver subtype, programmed death-1 ligand (PD-L1) score, and smoking status on the efficacy of PD-1/PD-L1 inhibitors in patients with oncogene-driven non-small cell lung cancer. Ng, TL., Liu, Y., Dimou, A., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Smoking History on Response to Immunotherapy in Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. Zhao, W., Jiang, W., Wang, H., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Tobacco Use and Response to Immune Checkpoint Inhibitor Therapy in Non-Small Cell Lung Cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy in Non-Small Cell Lung Cancer: Facts and Hopes. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Smoking on Response to the First-Line Treatment of Advanced ALK-Positive Non-Small Cell Lung Cancer: A Bayesian Network Meta-Analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Predictive value of oncogenic driver subtype, programmed death-1 ligand (PD-L1) score, and smoking status on the efficacy of PD-1/PD-L1 inhibitors in patients with oncogene-driven non-small cell lung cancer. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Smoking History on Response to Immunotherapy in Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. [2022]