Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

Shanghai Chest Hospital300 enrolled

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）.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 year

All cause of death

every reason that cause patient's death after ICIs treatment

Time frame: 1 year

examination indexes

The examination indexes that related to myocardial damage

Time frame: 1 year

Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts