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Monoclonal Antibodies

Canakinumab for Lung Cancer Prevention

Phase 2
Recruiting
Led By Jianjun Zhang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A male participant must agree to use contraception and refrain from donating sperm
Creatinine criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 7 months after treatment
Awards & highlights

Study Summary

This trial will test 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.

Who is the study for?
This trial is for adults with high-risk lung nodules who may develop lung cancer. They must have certain blood and organ function levels, agree to use contraception, and not be pregnant or breastfeeding. Those with active cancers, recent live vaccines, or psychiatric/substance issues can't join.Check my eligibility
What is being tested?
The Can-Prevent-Lung Trial is testing if the drug Canakinumab can prevent lung cancer in patients with risky pulmonary nodules. It's a phase II study where participants receive this monoclonal antibody that might stop tumor growth.See study design
What are the potential side effects?
Canakinumab could cause immune system reactions like infections or allergic responses since it targets inflammation pathways which are also important for normal defense mechanisms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control and not donate sperm during the study.
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My kidney function is stable without needing blood transfusions or erythropoietin in the last 2 weeks.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 7 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 7 months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Regression of indeterminate pulmonary nodules (IPNs)
Secondary outcome measures
Incidence of adverse events
Incidence of lung cancers
Lung cancer-free survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (canakinumab)Experimental Treatment2 Interventions
Patients receive canakinumab SC on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,296 Total Patients Enrolled
Jianjun ZhangPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Canakinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04789681 — Phase 2
Lung Cancer Research Study Groups: Prevention (canakinumab)
Lung Cancer Clinical Trial 2023: Canakinumab Highlights & Side Effects. Trial Name: NCT04789681 — Phase 2
Canakinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789681 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open opportunities to participate in this study?

"Affirmative. According to clinicaltrials.gov, this medical experiment is still recruiting participants and was first published on July 20th 2021 with updates occurring up until August 23rd 2022. 50 patients are required for the study at a single centre."

Answered by AI

What adverse effects are associated with Canakinumab?

"Canakinumab's safety rating is 2 according to our team at Power. This score reflects the fact there has been research done on its security but not yet any confirming efficacy."

Answered by AI

Is this an original research project?

"Canakinumab has been under research since 2018, when Novartis Pharmaceuticals sponsored the initial study with 1382 participants. After this trial, Phase 3 drug approval was granted and 16 active trials have sprung up in 263 cities across 52 nations."

Answered by AI

What is the estimated enrollment of this trial?

"Affirmative. Records posted on clinicaltrials.gov reveal that this investigation has been open since July 20th 2021, and was recently edited on August 23rd 2022; recruiting 50 participants from a single site."

Answered by AI

Has Canakinumab been tested in any past research studies?

"Currently, there are 16 active trials investigating the use of canakinumab with 3 studies in their third phase. Whilst most investigations into this molecule are conducted out of Houston, Texas, other 609 sites across the country have taken part in its clinical testing."

Answered by AI

In what scenarios is Canakinumab typically administered?

"Canakinumab is an effective intervention for muckle-wells syndrome (mws), active systemic juvenile idiopathic arthritis, and neonatal-onset multisystem inflammatory disease (nomid)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
2021. "Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04789681.
~19 spots leftby Dec 2025
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