Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

NCT ID: NCT04473703

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-08-01

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）.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

observation group

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.

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

Intervention Type: DRUG

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）

Interventions

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）

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xumin Hou

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yunhua Xu

Role: CONTACT

yhxu@shchest.org

86-021-22200000

Other Identifiers

SHXKYY202005

Identifier Type: -

Identifier Source: org_study_id