Canakinumab for Preventing Lung Cancer: The Can-Prevent-Lung Trial

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04789681

Provider View

This study is testing if canakinumab, a type of antibody, can help prevent lung cancer in people with high-risk lung nodules. The trial aims to see if this treatment can stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

This phase II trial is exploring whether canakinumab, a monoclonal antibody, can prevent lung cancer in patients with high-risk lung nodules. Canakinumab may work by interfering with the growth and spread of tumor cells. The study involves giving canakinumab to see if it can prevent lung cancer from developing.

Description

PRIMARY OBJECTIVE:

  • To find out if canakinumab can help reduce high-risk lung nodules.

SECONDARY OBJECTIVES:

  • To see if canakinumab can help people live longer without lung cancer.
  • To check if canakinumab lowers the chances of developing lung cancer.
  • To evaluate how safe and tolerable canakinumab is for patients with high-risk lung nodules.
  • To assess the quality of life of patients using canakinumab through their feedback.

EXPLORATORY OBJECTIVES:

  • To study changes in lung nodules with canakinumab treatment and their link to lung cancer risk and benefits or side effects.
  • To explore changes in immune cells and their link to lung cancer risk and benefits or side effects with canakinumab.
  • To examine changes in blood proteins and their link to lung cancer risk and benefits or side effects with canakinumab.

OUTLINE:

Patients receive canakinumab as an injection under the skin on day 1. This treatment is repeated every 21 days for up to 8 cycles unless the disease progresses or side effects become unacceptable. After finishing the study, patients are followed up for 30 days and at 6, 12, and 24 weeks.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be 18 years or older.
  • Must have high-risk lung nodules detected by CT scans, with specific cancer probability based on medical criteria.
  • Must agree to use contraception during treatment and for 6 months after.
  • Must have good overall health with specific blood and organ function levels.
  • Must not have had a blood transfusion or certain medications recently.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have received prior treatment with anti-IL1beta.
  • Have another active cancer needing treatment in the past year.
  • Have an active infection needing treatment.
  • Have psychiatric or substance abuse issues affecting trial participation.
  • Are receiving other cancer treatments not specified in the trial.
  • Have received live vaccines recently.

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