Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

• Conditions: Adverse Reactions; Immune Checkpoint Inhibitor; Cardiac Event; Non-Small Cell Lung Cancer Patients
• Interventions: Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor

• Registration Number: NCT04473703
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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）.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-15
• Last Update Submitted: 2020-07-15
• Study First Posted: 2020-07-16
• Last Update Posted: 2020-07-16
• Study Start: 2020-08-01
• Primary Completion: 2022-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observation group	renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor	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.

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	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 Outcome Measures

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