50 Participants Needed

Canakinumab for Lung Cancer Prevention

JZ
Overseen ByJianjun Zhang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

JZ

Jianjun Zhang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.
See 8 more

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.
See 5 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Prevention (canakinumab)Experimental Treatment2 Interventions

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

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Approved in European Union as Ilaris for:
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Approved in United States as Ilaris for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

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]
Overcoming immunosuppression and pro-tumor inflammation in lung cancer with combined IL-1β and PD-1 inhibition. [2022]
Effects of the NF-κB Pathway Agonist IL-1β on Non-Small Cell Lung Cancer Cell Lines. [2021]
Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design. [2021]
Canakinumab. [2021]
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