Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

Cardiac Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04473703
• Other study ID #: SHXKYY202005
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: July 2020
• Source: Shanghai Chest Hospital
• Contact: Yunhua Xu
• Phone: 86-021-22200000
• Email: yhxu[@]shchest.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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）.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Reactions
• Carcinoma, Non-Small-Cell Lung
• Cardiac Event
• Immune Checkpoint Inhibitor
• Lung Neoplasms
• Non-Small Cell Lung Cancer Patients

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	All cause of death	every reason that cause patient's death after ICIs treatment	1 year
Secondary	examination indexes	The examination indexes that related to myocardial damage	1 year