Actively Recruiting
Single Arm Phase II Trial Using Canakinumab for the Prevention of Lung Cancer (Can-Prevent-Lung)
Led by M.D. Anderson Cancer Center ยท Updated on 2026-04-16
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating canakinumab, a monoclonal antibody, to see if it can prevent lung cancer in patients with high-risk pulmonary nodules. This phase II trial aims to determine if canakinumab can increase the regression of these nodules, prolong lung cancer-free survival, reduce lung cancer incidence, and assess its safety, tolerability, and impact on quality of life. Exploratory goals include studying radiographic changes, immune system markers, and serum factors related to lung cancer risk and treatment effects. Participants receive canakinumab as a subcutaneous injection on day 1, repeating every 21 days for up to 8 cycles, provided there is no disease progression or unacceptable side effects. After completing treatment, patients are followed up at 30 days and then at 6, 12, and 24 weeks to monitor outcomes and safety. Quality of life assessments and additional exploratory studies are included during and after treatment. During the study, patients undergo CT scans to measure nodule changes and complete questionnaires to report their quality of life. Researchers track lung cancer-free survival, incidence of lung cancers, and adverse events up to 24 weeks. Blood tests and immune system evaluations are performed to explore treatment effects. The total participation duration includes treatment cycles and follow-up visits spanning several months to closely monitor patient health and study outcomes.
CONDITIONS
Brief Title
Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant provides written informed consent
- Adults aged 18 years or older at consent
- Persistent indeterminate pulmonary nodules on two CT scans at least 3 months apart with no shrinkage
- Nodules detected by low dose CT lung cancer screening or incidental imaging
- Cancer probability of nodules between 10-30% by Brock University equation without prior lung cancer history
- Cancer probability over 30% with negative biopsy and no prior lung cancer history
- History of stage I-III non-small cell lung cancer with completed curative treatment and persistent nodules with 5-30% cancer probability
- History of stage I-III NSCLC with persistent nodules over 30% cancer probability and negative biopsy
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Adequate blood counts, kidney and liver function within 10 days before treatment
- Males agree to use contraception during treatment and for 6 months after last dose
- Females not pregnant, breastfeeding, and either not of childbearing potential or agree to contraception during and 6 months after treatment
You will not qualify if you...
- Positive pregnancy test within 72 hours before treatment for women of childbearing potential
- Prior therapy with anti-IL1beta agents
- Known progressing malignancy or requiring treatment within past year except certain skin or in situ cancers
- Active infection requiring systemic treatment
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant, breastfeeding, or planning pregnancy during study and 6 months after last dose
- Receiving other antineoplastic chemotherapy, biological, immunotherapy, or investigational agents besides canakinumab
- Received live vaccines within 30 days before first dose and during study (except certain killed vaccines like flu injection)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive canakinumab by subcutaneous injection every 21 days for up to 8 cycles, unless disease progresses or unacceptable toxicity occurs.
Up to 8 treatment visits every 3 weeks
Duration - Approximately 24 weeks
After completing treatment, participants are followed for safety and outcomes with visits at 30 days, 6 weeks, 12 weeks, and 24 weeks.
4 follow-up visits
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jianjun Zhang
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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