Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using canakinumab to prevent lung cancer in high-risk patients

Official title: Single Arm Phase II Trial Using Canakinumab for the Prevention of Lung Cancer (Can-Prevent-Lung)

Run by M.D. Anderson Cancer Center · NCT04789681 · Data updated 2026-11-12

This study is testing if a medication called canakinumab can help prevent lung cancer in people who have high-risk lung nodules.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorM.D. Anderson Cancer Center
Academic / other
Drugs / interventionscanakinumab, chemotherapy, immunotherapy
Locations1 site (Houston, Texas)
StatusRecruiting
StartedJuly 20, 2021
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedJune 12, 2026
Trial IDNCT04789681 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with persistent indeterminate pulmonary nodules that have a 10-30% or greater than 30% probability of cancer, as determined by the Brock University cancer prediction equation.

Probably not a fit

Patients with a history of lung cancer or those without high-risk pulmonary nodules may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effects of canakinumab, a monoclonal antibody, on preventing lung cancer in patients with high-risk pulmonary nodules. The primary objective is to determine if canakinumab increases the regression rate of these nodules. Secondary objectives include assessing lung cancer-free survival, incidence reduction of lung cancers, and evaluating the safety and tolerability of canakinumab. Additionally, the study will explore the quality of life of participants and the biological changes associated with treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of lung cancer in high-risk patients.

How similar studies have gone: While the use of canakinumab in this context is novel, similar approaches targeting immune modulation have shown promise in other cancer prevention studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

  • M D Anderson Cancer Center
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.