Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume

Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume in Patients With Non-Small Cell Lung Cancer: A Case-Control Study

In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment leads to an accelerated progression of atherosclerosis in patients with lung cancer. Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being targeted for cancer are critical negative regulators of atherosclerosis in animal and cellular models. Aortic plaque progression will be compared between cases (on ICI) and controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will be matched for age, cancer type and stage and cardiovascular risk factors. Traditional markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination therapy, number of cycles, occurrence of immune-related adverse events, chest radiation, steroid use) will be associated with the change in aortic plaque volume.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with non-small cell lung cancer from a single tertiary care center in the United States.

Description

Inclusion Criteria:

Cases:

• Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors.
• Available contrast enhanced CT scans of the chest both immediately pre-ICI (< 1 month) and latest follow-up.

Controls:

• Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk factor matched to cases.
• Available contrast enhanced CT scan of the chest at two time-points at a similar interval between scans as the cases.

Exclusion Criteria:

none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in aortic plaque volume	The change of plaque burden after starting ICIs will be calculated and compared with the pre-ICI study. The change in plaque burden in controls will be calculated and compared from two studies at a similar median interval as ICI cases.	Three years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Atherosclerosis; Non-small Cell Lung Cancer; Immune Checkpoint Inhibitor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Anatomical; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Plaque, Atherosclerotic
• Other Study ID Numbers: 2020P000361

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No