Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

Overview

This is a prospective, open label, single arm study. A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included . All patients will follow up for at least 1 year. Patients with cardiac adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or during the subsequently follow-up period will randomly assigned a random number to each patient by computer random sequence. Patients with odd random number will treat with RASI(renin-angiotensin system inhibitors), and those with even random number will treat with ARNI(angiotensin-receptor-neprilysin inhibitor).

Full Title of Study: “A Prospective Study of Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in Non-Small Cell Lung Cancer Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 1, 2022

Interventions

  • Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor
    • Patients with odd random number will treat with RASI(renin-angiotensin system inhibitors), and those with even random number will treat with ARNI(angiotensin-receptor-neprilysin inhibitor)

Arms, Groups and Cohorts

  • observation group
    • A total of 300 patients are expected to include in this group. And the cardiac adverse reactions related to immune checkpoint inhibitor will be observed.

Clinical Trial Outcome Measures

Primary Measures

  • Major Adverse Cardiovascular Events
    • Time Frame: 1 year
    • a) Primary Outcome is Major Adverse Cardiovascular Events(MACE)related to ICIs,includes: cardiovascular death, myocardial infarction(nonfatal), stroke(nonfatal), heart failure that caused readmission

Secondary Measures

  • Common Terminology Criteria for Adverse Events (CTCAE)
    • Time Frame: 1 year
    • Common Terminology Criteria for Adverse Events (CTCAE) related to ICIs, includes: arrhythmia, cardiogenic chest pain, valvular heart disease, cardiomyopathy, myocardial pericardial disease
  • All cause of death
    • Time Frame: 1 year
    • every reason that cause patient’s death after ICIs treatment
  • examination indexes
    • Time Frame: 1 year
    • The examination indexes that related to myocardial damage

Participating in This Clinical Trial

Inclusion Criteria

1. Be willing and able to provide written informed consent/assent for the trial; 2. Lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage III~IV; 3. Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least two courses; Exclusion Criteria:

1. Patients who do not have pathological diagnosis; 2. Patients who can't finish the follow-up; 3. The anti-PD-1, anti-PD-L1 therapy was less than two courses; 4. Patients whose cancer diagnosed with small cell lung cancer.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Chest Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xumin Hou, Chief physician – Shanghai Chest Hospital
  • Overall Contact(s)
    • Yunhua Xu, 86-021-22200000, yhxu@shchest.org

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