Study on Pembrolizumab for Preventing Lung Cancer in Patients with Early-Stage Non-Small Cell Lung Cancer or High-Risk Lung Nodules

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03634241

Provider View

This clinical trial is testing whether the drug pembrolizumab can help prevent lung cancer in patients with early-stage non-small cell lung cancer or those with high-risk lung nodules. Pembrolizumab is an immunotherapy that may help the immune system attack cancer cells and stop them from growing and spreading.

Patient Parameters

Program Overview

The purpose of this study is to see if pembrolizumab, an immunotherapy drug, can prevent lung cancer in patients with early-stage non-small cell lung cancer or high-risk lung nodules. Pembrolizumab works by helping the immune system target and destroy cancer cells, potentially stopping them from growing and spreading.

Description

The main goal of this study is to find out if pembrolizumab can eliminate high-risk lung nodules that have not changed in size over two CT scans taken at least three months apart.

Other goals include:

  • Checking if pembrolizumab reduces the number of lung cancers confirmed by biopsy.
  • Seeing if pembrolizumab helps patients live longer without cancer compared to just monitoring them.
  • Evaluating if pembrolizumab improves survival specifically related to lung cancer.
  • Assessing the overall survival of patients taking pembrolizumab.
  • Monitoring the safety and side effects of pembrolizumab.
  • Comparing the quality of life of patients taking pembrolizumab to those who are just being observed.
  • Investigating if pembrolizumab reduces the solid part of high-risk lung nodules.
  • Exploring changes in patients' quality of life during the study.

The study will also explore various scientific aspects, such as changes in lung nodules on scans, genetic factors, immune system responses, and other biological markers, to understand how pembrolizumab works and its potential benefits and risks.

Participants will receive pembrolizumab through an IV every three weeks for up to four cycles, as long as the disease does not progress and side effects are manageable. They will also have CT scans and blood tests throughout the trial. After finishing the treatment, participants will have follow-up visits at three and six months.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with high-risk lung nodules detected by screening or other imaging tests.
  • No history of lung cancer, or have completed treatment for early-stage non-small cell lung cancer.
  • Lung nodules must have a certain probability of being cancerous, as determined by a specific prediction equation.
  • Willing to use effective birth control during the study and for a specified period after treatment.
  • Able to provide written informed consent.
  • In good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function based on specific blood test results.

Exclusion Criteria

  • Currently require oxygen for lung diseases.
  • Have a history of lung inflammation or diseases requiring steroid treatment.
  • Pregnant or breastfeeding women.
  • Have received certain prior cancer treatments or vaccines recently.
  • Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
  • Have another active cancer requiring treatment.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have active autoimmune diseases needing treatment in the past two years.
  • Have active infections or a history of certain viral infections like HIV or hepatitis.
  • Have a history of tuberculosis.
  • Have any condition or situation that might interfere with the study or not be in the participant's best interest.
  • Have psychiatric or substance abuse issues that would affect participation.
  • Expecting to conceive or father children during the study or shortly after.

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