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Prevention study for Lung Carcinoma
Official title Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
ClinicalTrials.gov ID: NCT04789681
What this study is testing
What is Canakinumab?
Canakinumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for lung carcinoma.
Also referred to as ACZ885, Ilaris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Patients with history of stage I-III non-small cell lung cancer (NSCLC), who have completed treatment with curative intent, who have persistent IPNs...
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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%...
- 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...
- 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 =\ = 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 (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...
What rules you out
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.