RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 30 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After completion of study, patients are followed up for 30 days and at 6, 12, and 24 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase II study tests whether canakinumab can help prevent lung cancer. It is for adults with lasting lung nodules (spots in the lungs) that may become cancer, including some people treated for lung cancer before. Canakinumab is an antibody drug that may block cancer cells from growing and spreading.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and give written consent, either yourself or through a legally approved representative.
  • Have lung spots that have not shrunk on two CT scans taken at least 3 months apart.
  • If you have never had lung cancer: have a calculated cancer risk of 10–30%, or above 30% with a biopsy (tissue sample) showing no clear cancer.
  • If you had stage I–III non-small cell lung cancer: have finished treatment meant to cure it. Your lung spots must have a calculated cancer risk of 5–30%, or above 30% with a biopsy showing no clear cancer.
  • Be fully active or able to do light work, based on an activity check within 7 days before treatment.
  • Have blood cell counts and kidney and liver test results within the study's limits, checked within 10 days before treatment. You must not depend on medicine to boost red blood cells or have had a red blood cell transfusion in the past 2 weeks.
  • Men must use birth control and not donate sperm during treatment and for 6 months after the last dose.
  • Women must not be pregnant or breastfeeding. Those who can become pregnant must follow birth control rules during treatment and for at least 6 months after the last dose.

Who can't join

  • Are pregnant, breastfeeding, or planning to conceive a child during the study or within 6 months after the last dose. Those who can become pregnant need a negative pregnancy test before treatment.
  • Have had treatment with an anti-IL1beta drug, which blocks a protein involved in swelling and inflammation.
  • Have another cancer that is growing or needed treatment in the past year. Some treated skin cancers and cancers that have not spread beyond where they started are allowed.
  • Have an active infection that needs medicine that works throughout the body.
  • Have a mental health or substance use disorder that would keep you from following study requirements.
  • Receive cancer drugs, immune treatments, or other experimental drugs that the study does not allow during screening or treatment.
  • Received a live vaccine within 30 days before the first dose, or receive one during the study. Regular injected flu vaccines are allowed, but the live nasal spray flu vaccine is not.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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)

Study sites (1)

TX