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Monoclonal Antibodies

Canakinumab for Lung Cancer Risk Reduction in Former-Smokers

Phase 2

Waitlist Available

Led By Peter G Shields, MD

Research Sponsored by Peter Shields

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 55-73 (age criteria aligns with Canakinumab Antiinflammatory Thrombosis Outcome Study [CANTOS] trial)

Former smoker with no use in >= 5 years prior to enrollment (targets former smoker population)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and day 77

Awards & highlights

Study Summary

This trial tests if canakinumab can reduce cancer risk in former smokers by blocking a protein linked to inflammation.

Who is the study for?

This trial is for former smokers aged 55-73 with a history of heavy smoking (30+ pack-years) and high inflammation markers (hsCRP >= 2 mg/L). Participants must not have smoked or used tobacco/vaping products in the last five years. Women should be post-menopausal, on contraception, or sterilized. People with unstable medical conditions, recent serious infections like COVID-19, or those taking certain medications are excluded.Check my eligibility

What is being tested?

The trial is testing canakinumab's effects on reducing cancer growth risk by examining its impact on inflammatory biomarkers in biologic samples from high-risk former smokers. Canakinumab targets interleukin-1 beta to potentially disrupt cancer-promoting inflammation.See study design

What are the potential side effects?

Canakinumab may cause side effects related to immune system suppression such as increased infection risk, allergic reactions, and potential interactions with other drugs that affect the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 55 and 73 years old.

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I quit smoking more than 5 years ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and day 77

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and day 77

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and day 77 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in ASCs

Change in caspase-1

Change in interleukin-1 beta (IL-1beta)

Secondary outcome measures

Bronchoscopy for fractional concentration of exhaled nitric oxide (FeNO)

Changes in BAL

Changes in cytokines in the blood

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (canakinumab, bronchoscopy)Experimental Treatment5 Interventions

Patients undergo bronchoscopy over 30-60 minutes and receive canakinumab SC 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and CO testing on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Canakinumab

2011

Completed Phase 3

~3090

Bronchoscopy

2002

Completed Phase 2

~2300

Biospecimen Collection

2004

Completed Phase 2

~1730

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Peter ShieldsLead Sponsor

Peter G Shields, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Frequently Asked Questions

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

Is the age eligibility for this study limited to those under 40 years old?

"This medical trial seeks individuals aged 55 to 73 who may be eligible for enrolment."

Answered by AI

Could I be considered a possible candidate for this research?

"This lung cancer trial seeks 75 individuals aged between 55 and 73 to participate. In order to be accepted, an applicant must meet the age criteria as well as suffer from this malignant disease."

Answered by AI

Are any new participants being onboarded for this investigation?

"Contrary to expectations, according to clinicaltrials.gov the trial is no longer recruiting patients; it was initially posted on September 30th 2023 and last edited on September 6th 2023. Fortunately though, there are still 2591 other studies actively enrolling participants at this time."

Answered by AI

Is the FDA sanctioning canakinumab and bronchoscopy for preventive purposes?

"As this is a Phase 2 trial, with only some data affirming its safety but no evidence for efficacy, our experts at Power rated Prevention (canakinumab, bronchoscopy) to be of moderate security – that is, it received a score of 2."

Answered by AI

What outcomes is this trial hoping to realize?

"This medical study, which will be tracked over a period of 77 days from baseline, has the primary goal to measure changes in caspase-1. Secondary objectives include recording alterations in cytokines through human magnetic luminex assay on Luminex platform and RNASeq technology as well as BAL (bronchoalveolar lavage) assessment with same methods. Lastly, bronchoscopy is used to calculate fractional concentration of exhaled nitric oxide (FeNO)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Canakinumab in High-Risk Former-Smokers

Peter Shields 2023. "Evaluation of Canakinumab in High-Risk Former-Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038526.