Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

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

Treatments tested in this trial

  • Canakinumab
  • Quality-of-Life Assessment

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators