Canakinumab for Preventing Lung Cancer in High-Risk Patients
This study is testing a drug called canakinumab to see if it can prevent lung cancer in people who have high-risk lung nodules (small growths in the lung). Canakinumab is a monoclonal antibody, a type of drug that may help stop cancer cells from growing. Researchers want to see if giving canakinumab can make these nodules shrink. The study will also look at how safe canakinumab is and how it affects your quality of life. About 50 people will participate. The current status of this study is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.
- What's involved
- Canakinumab will be given subcutaneously (SC), meaning under the skin. Quality-of-Life Assessments will also be conducted.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, regression of indeterminate pulmonary nodules, will be measured at 7 months after treatment.
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NCT04789681
Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
Recruiting
PHASE2Ages 18+InterventionalPreventionM.D. Anderson Cancer CenterInvestigator-initiated
~50 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:CanakinumabQuality-of-Life Assessment
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Regression of indeterminate pulmonary nodules (IPNs)
Measured over At 7 months after treatment
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Jianjun Zhang · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
The participant (or legally authorized representative if applicable) provides written informed consent for the trial
Participants are eligible to be included in the study if one of the following criteria applies:
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
Patients with history of stage I-III 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 \> 30% cancer probability by Brock University cancer prediction equation, but biopsy showed no clear evidence of malignancy
At least 18 years of age on the day of signing informed consent
A male participant must agree to use a contraception during the treatment period plus an additional 6months (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after study treatments with risk of genotoxicity after the last dose of study treatment
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the start of study treatment
Absolute neutrophil count (ANC) \>= 1500/uL (collected within 10 days prior to the start of study treatment)
Platelets \>= 100 000/uL (collected within 10 days prior to the start of study treatment)
Hemoglobin \>= 9.0 g/dL or \>= 5.6 mmol/L (collected within 10 days prior to the start of study treatment)
Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
Creatinine =\< 1.5 x upper limit or normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 30 mL/min for participant with creatinine levels \> 1.5 x institutional ULN (collected within 10 days prior to the start of study treatment)
Creatinine clearance (CrCl) should be calculated per institutional standard
Total bilirubin =\< 1.5 x ULN OR direct bilirubin =\< ULN for participants with total bilirubin levels \> 1.5 x ULN (collected within 10 days prior to the start of study treatment)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x ULN (collected within 10 days prior to the start of study treatment)
Exclusion
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
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of trial treatment
Is receiving the following therapies during the screening and treatment phases (including retreatment for post-complete response relapse) of this trial: antineoplastic systemic chemotherapy or biological therapy, immunotherapy not specified by this protocol, chemotherapy not specified by this protocol, investigational agents other than canakinumab
Has received live vaccines within 30 days prior to first dose of study treatment and while participating in the study. Examples of live vaccines include but are not limited to: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. (Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (eg FluMist are live attenuated vaccines are not allowed)
What this trial measures
- Regression of indeterminate pulmonary nodules (IPNs)At 7 months after treatment
Will assess complete response or partial response by modified Response Evaluation Criteria in Solid Tumors criteria.