MedTrace Logo

Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

NCT04473703 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-07-16

No results posted yet for this study

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

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）

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-08-01
Completion
2023-08-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473703 on ClinicalTrials.gov