Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

Study Overview
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Brief Summary
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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）.

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

Conditions
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Adverse Reactions, Immune Checkpoint Inhibitor, Non-Small Cell Lung Cancer Patients, Cardiac Event

Intervention / Treatment
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* Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be willing and able to provide written informed consent/assent for the trial; Lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage III IV; Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least two courses; Exclusion Criteria: Patients who do not have pathological diagnosis; Patients who can't finish the follow-up; The anti-PD-1, anti-PD-L1 therapy was less than two courses; Patients whose cancer diagnosed with small cell lung cancer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observation group<br>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. | Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor<br>* 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）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | 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 | 1 year | 

Secondary Outcome Measures

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