Canakinumab for Lung Cancer Prevention

Overseen By Jianjun Zhang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anti-IL1beta, Immunotherapy

Disqualifiers: Active infection, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 24 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effects of canakinumab in preventing lung cancer in patients who have high-risk pulmonary nodules. Canakinumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving canakinumab may prevent the development of lung cancer.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on certain cancer treatments or investigational drugs other than canakinumab. It's best to discuss your specific medications with the trial team.

How is the drug Canakinumab unique for lung cancer prevention?

Canakinumab is unique because it targets IL-1β, a protein involved in inflammation, which may help reduce lung cancer risk by decreasing pro-tumor inflammation. Unlike standard treatments, it is being explored as a potential chemotherapy-free option, possibly enhancing the effectiveness of existing immune therapies. ^{1 2 3 4 5}

Research Team

Jianjun Zhang

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with high-risk lung nodules who may develop lung cancer. They must have certain blood and organ function levels, agree to use contraception, and not be pregnant or breastfeeding. Those with active cancers, recent live vaccines, or psychiatric/substance issues can't join.

Inclusion Criteria

I agree to use birth control and not donate sperm during the study.

My kidney function is stable without needing blood transfusions or erythropoietin in the last 2 weeks.

Your bilirubin levels in your blood need to be within a certain range.

Exclusion Criteria

Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have another cancer that is getting worse or was treated in the last year.

I am currently taking specific medications as part of this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive canakinumab subcutaneously on day 1, with treatment repeating every 21 days for up to 8 cycles

24 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

3 visits (in-person)

Treatment Details

Interventions

• Canakinumab

Trial Overview The Can-Prevent-Lung Trial is testing if the drug Canakinumab can prevent lung cancer in patients with risky pulmonary nodules. It's a phase II study where participants receive this monoclonal antibody that might stop tumor growth.

Participant Groups

Group I: Prevention (canakinumab) Experimental Treatment 2 Interventions

Patients receive canakinumab SC on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Canakinumab is already approved in European Union, United States for the following indications:

Approved in European Union as Ilaris for:

• 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)

Approved in United States as Ilaris for:

• 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)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In a phase III study involving 643 patients with advanced non-small-cell lung cancer, the addition of canakinumab to standard treatment did not significantly improve progression-free survival (PFS) or overall survival (OS) compared to placebo.

Despite the lack of survival benefit, canakinumab was found to delay the deterioration of lung cancer symptoms, indicating potential quality of life improvements for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. Tan, DSW., Felip, E., de Castro, G., et al.[2023]

Canakinumab, an anti-IL-1β antibody, has shown promise in reducing lung cancer incidence, suggesting that targeting inflammation in the tumor microenvironment can enhance cancer treatment outcomes.

The CANOPY program is investigating the combination of canakinumab with PD-1 inhibition as a potential chemotherapy-free immunotherapy strategy, particularly for patients with non-small-cell lung cancer who typically have low PD-L1 expression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming immunosuppression and pro-tumor inflammation in lung cancer with combined IL-1β and PD-1 inhibition. Lee, JM., Tsuboi, M., Kim, ES., et al.[2022]

Canakinumab, an IL-1β inhibitory antibody, shows potential in reducing lung cancer incidence based on previous trials, prompting further investigation into its mechanism in lung cancer treatment.

In co-cultures of lung cancer cells and macrophages, IL-1β levels were significantly higher compared to monocultures, suggesting that interactions between these cells may enhance IL-1β expression and activate the NF-κB pathway, highlighting its role as a potential therapeutic target.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the NF-κB Pathway Agonist IL-1β on Non-Small Cell Lung Cancer Cell Lines. Liu, D., Liu, XQ., Kiefl, R., et al.[2021]

The CANOPY-N trial is a Phase II study designed to evaluate the effectiveness of canakinumab, an IL-1β inhibitor, in treating non-small-cell lung cancer, potentially reducing lung cancer incidence based on previous findings from the CANTOS trial.

Patients with stage IB to IIIA non-small-cell lung cancer will receive either canakinumab or pembrolizumab, alone or in combination, with the primary goal of assessing major pathological response, which will help determine the treatment's efficacy before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design. Garrido, P., Pujol, JL., Kim, ES., et al.[2021]

Canakinumab is an effective treatment for inflammatory diseases like familial cold auto-inflammatory syndrome and Muckle-Wells syndrome, as it neutralizes IL-1beta signaling to reduce inflammation.

The drug is generally well-tolerated with no serious adverse effects reported, and it offers benefits such as bimonthly administration and approval for use in children, making it a promising option for various autoimmune conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canakinumab. Dhimolea, E.[2021]

References

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

Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Overcoming immunosuppression and pro-tumor inflammation in lung cancer with combined IL-1β and PD-1 inhibition. [2022]

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

Effects of the NF-κB Pathway Agonist IL-1β on Non-Small Cell Lung Cancer Cell Lines. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design. [2021]

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

Canakinumab. [2021]