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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

Must not have

Known additional malignancy that is progressing or has required active treatment within the past year

Receiving specific therapies during the screening and treatment phases of this trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 7 months after treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer that is getting worse or was treated in the last year.

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I am currently taking specific medications as part of this study.

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I am a woman of childbearing potential and my recent pregnancy test was positive.

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I have been treated with an anti-IL1beta therapy before.

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I am currently on medication for an infection.

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I have not received any live vaccines in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 7 months after treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Regression of indeterminate pulmonary nodules (IPNs)

Secondary study objectives

Lung cancer-free survival

Quality of life questionnaires

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met