Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430712
• Other study ID #: 2020P000361
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: August 22, 2022

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 22, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Plaque, Atherosclerotic

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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