Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Reactions | — | UNRESOLVED | — |
| Cardiac Event | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitor | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- observation group
- description
- 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.
- interventionNames
- Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor
Primary outcomes (1)
- measure
- Major Adverse Cardiovascular Events
- timeFrame
- 1 year
- description
- 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
Secondary outcomes (3)
- measure
- Common Terminology Criteria for Adverse Events (CTCAE)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available