NCT04473703

Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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）.

Conditions

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

Interventions

Type	Name	Description
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）

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-08-01
• Completion: 2023-08-01
• First posted: 2020-07-16
• Last updated: 2020-07-16