Canakinumab for Lung Cancer Prevention
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Anti-IL1beta, Immunotherapy
Disqualifiers: Active infection, Psychiatric disorders, 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 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
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.
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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.
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Trial 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 (Monoclonal Antibodies)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Prevention (canakinumab)Experimental Treatment2 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
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]The addition of checkpoint inhibitors to first-line treatment has prolonged survival of patients with non-small-cell lung cancer (NSCLC), but prognosis remains poor, with new treatment options needed. Canakinumab, a human, monoclonal anti-interleukin (IL)-1β antibody, has potential to enhance the activity of PD-L1 inhibitors and chemotherapy (CT) by inhibiting protumor inflammation.
Overcoming immunosuppression and pro-tumor inflammation in lung cancer with combined IL-1β and PD-1 inhibition. [2022]Inflammation in the tumor microenvironment is a complicit and known carcinogenesis driver. Inhibition of IL-1β, one of the most abundant and influential cytokines in the tumor microenvironment, may enhance the efficacy of PD-1. In a post-hoc analysis of phase III cardiovascular CANTOS trial, canakinumab, a monoclonal anti-IL-1β antibody, significantly reduced lung cancer incidence. Immune checkpoint inhibition (ICI) is the standard of care in non-small-cell lung cancer. However, ICI efficacy is heavily impacted by programmed death ligand-1 (PD-L1) status. Most patients with non-small-cell lung cancer have low PD-L1 expression levels. Thus, combinational strategies are needed to improve ICI efficacy and expand its use. Here, we describe the preclinical and clinical evidence to support the combination of IL-1β and PD-1 under investigation in the CANOPY program. The perioperative use of canakinumab with or without PD-1 inhibition in the CANOPY-N trial is described as a potential chemotherapy-free immunotherapy strategy.
Effects of the NF-κB Pathway Agonist IL-1β on Non-Small Cell Lung Cancer Cell Lines. [2021]Canakinumab is an interleukin (IL)-1β inhibitory antibody. Recently, a large trial of canakinumab in cardiac patients described lower lung cancer incidence in patients treated with canakinumab compared to controls. This finding is the basis for ongoing clinical trials of canakinumab in lung cancer. To address the underlying mechanism, we established lung cancer co-cultures to investigate the interactions between lung cancer cells and immunocyte macrophages as related to the expression of IL-1β and the effect of IL-1β on the NF-κB pathway on lung cancer cells.
Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design. [2021]Canakinumab is a human IgGκ monoclonal antibody, with high affinity and specificity for IL-1β. The Canakinumab Anti-Inflammatory Thrombosis Outcome Study (CANTOS) trial, evaluating canakinumab for cardiovascular disease, provided the first signal of the potential of IL-1β inhibition on lung cancer incidence reduction. Here, we describe the rationale and design for CANOPY-N, a randomized Phase II trial evaluating IL-1β inhibition with or without immune checkpoint inhibition as neoadjuvant treatment in patients with non-small-cell lung cancer. Patients with stage IB to IIIA non-small-cell lung cancer eligible for complete resection will receive canakinumab or pembrolizumab as monotherapy, or in combination. The primary end point is major pathological response by central review; secondary end points include overall response rate, major pathological response (local review), surgical feasibility rate and pharmacokinetics. Clinical trial registration: NCT03968419 (ClinicalTrials.gov).
Canakinumab. [2021]Canakinumab (ACZ885, Ilaris) is a human anti-IL-1beta monoclonal antibody developed by Novartis. Its mode of action is based on the neutralization of IL-1beta signaling, resulting in suppression of inflammation in patients with disorders of autoimmune origin. In June 2009 the drug was approved by the US Food and Drug Administration for the treatment of familial cold auto-inflammatory syndrome and Muckle-Wells syndrome, which are inflammatory diseases related to cryopyrin-associated periodic syndromes. The drug is currently being evaluated for its potential in the treatment of rheumatoid arthritis, systemic-onset juvenile idiopathic arthritis, chronic obstructive pulmonary disease, type 1 and 2 diabetes and ocular diseases. Reports from clinical trials suggest that canakinumab is well-tolerated in most patients, and no serious adverse effects have been reported. The drug provides significant advantages over existing competitive therapies, including bimonthly administration and approved use in children.