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.
Eligibility criteria
This trial does not accept healthy volunteers
Qualifiers
The participant (or legally authorized representative if applicable) provides written informed consent for the trial
Patients with no history of lung cancer, who have persistent IPNs (on two computed tomography [CT] scans at least 3 months apart with no evidence of shrinkage or regression) detected by low dose computed tomography [LDCT]-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with 10-30% cancer probability by Brock University cancer prediction equation as following
Patients with no history of lung cancer, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) detected by LDCT-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with > 30% cancer probability by Brock University cancer prediction equation as following, but biopsy showed no clear evidence of malignancy
Patients with history of stage I-III non-small cell lung cancer (NSCLC), who have completed treatment with curative intent, who have persistent IPNs (on two CT scans at least 3 months apart with no evidence of shrinkage or regression) with 5-30% cancer probability by Brock University cancer prediction equation as following
Disqualifiers
A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication
Has received prior therapy with an anti-IL1beta
Has a known additional malignancy that is progressing or has required active treatment within the past year. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
Has an active infection requiring systemic therapy
Trial design
Design model
Single group
Treatments tested in this trial
Canakinumab
Drug
Given SC
Quality-of-Life Assessment
Other intervention
Ancillary studies
Treatment groups
50 Participants
are divided into 1 treatment group
Group A: Prevention (canakinumab)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Regression of indeterminate pulmonary nodules (IPNs)
Will assess complete response or partial response by modified Response Evaluation Criteria in Solid Tumors criteria.
Time frame
At 7 months after treatment
Secondary outcomes
1
Lung cancer-free survival
Will be computed using the Kaplan-Meier method.
Time frame
Up to 24 weeks
2
Incidence of lung cancers
Time frame
Up to 24 weeks
3
Incidence of adverse events
Time frame
Up to 24 weeks
4
Quality of life questionnaires
Assessed using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score ranges (1-4) 1-Not at all, 2-A little, 3-Quite a bit, 4-Very Much
Time frame
Baseline and 24 weeks
Other outcomes
Sponsors and contacts
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