Actively Recruiting
Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
50
Participants Needed
1
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant or their legal representative provides written informed consent
- Age 18 years or older at signing consent
- Persistent indeterminate pulmonary nodules on two CT scans at least 3 months apart without shrinkage or regression
- Nodules detected by low dose CT lung screening or other imaging with 10-30% or >30% cancer probability by Brock University cancer prediction
- Patients with no history of lung cancer or patients with history of stage I-III non-small cell lung cancer who have completed curative treatment
- Male participants must agree to use contraception during treatment and for 6 months after last dose
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to contraception during treatment and for 6 months after last dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 evaluated within 7 days prior to treatment
- Absolute neutrophil count ≥ 1500/uL within 10 days prior to treatment
- Platelets ≥ 100,000/uL within 10 days prior to treatment
- Hemoglobin ≥ 9.0 g/dL without recent erythropoietin use or blood transfusion within 2 weeks
- Creatinine ≤ 1.5 times upper limit of normal or creatinine clearance ≥ 30 mL/min within 10 days prior to treatment
- Total bilirubin ≤ 1.5 times upper limit of normal or direct bilirubin ≤ upper limit of normal within 10 days prior to treatment
- AST and ALT ≤ 2.5 times upper limit of normal within 10 days prior to treatment
You will not qualify if you...
- Women of childbearing potential with a positive pregnancy test within 72 hours prior to treatment
- Prior therapy with anti-IL1beta agents
- Known additional progressing malignancy or requiring treatment within the past year, except treated basal cell or squamous cell skin cancers and carcinoma in situ
- Active infection requiring systemic therapy
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnant, breastfeeding, or planning to conceive during study and for 6 months after last treatment dose
- Receiving antineoplastic chemotherapy, biological therapy, immunotherapy not in this protocol, or other investigational agents besides canakinumab during screening and treatment
- Received live vaccines within 30 days prior to first treatment dose or while in the study except killed virus influenza vaccines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jianjun Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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