Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

Shanghai Jiao Tong University

Status: Unknown

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

Treatments: Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT04473703

SHXKYY202005

Details and patient eligibility

About

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）.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

observation group

Description:

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.

Treatment:

Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor