The Efficacy and Safety of ARNI on the Outcome of Advanced Lung Cancer With Concurrent Hypertension

A Prospective Study of the Efficacy and Safety of Angiotensin Receptor-neprilysin Inhibitor in Patients With Advanced Lung Cancer and Concurrent Hypertension

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07261098

Enrollment

200

Registered

2025-12-03

Start date

2026-01-01

Completion date

2028-12-31

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Lung Cancer

Brief summary

Despite the rapid development of novel anti-cancer therapeutic agents and ensuing improved prognosis, lung cancer remains the leading cause of cancer-related death globally, of which the majority of mortality could be attributed to advanced lung cancer. Hypertension is frequently diagnosed among patients with advanced lung cancer, either a comorbidity or complication, and is associated with increased incidence of cardiac adverse events, such as heart failure, coronary artery disease, and cardiac arrhythmias, hence aggravating patients' prognosis. Sacubitril/valsartan, a combination of an angiotensin II receptor blocker and neprilysin inhibitor (ARNI), is a novel agent to treat HF and has been approved to treat hypertension in China, of which the cardio-protective effect has been widely acknowledged. Yet current knowledge remains lacking on the influence of ARNI on the prognosis of advanced lung cancer with concurrent hypertension. The present study aimed to investigate the prognostic value of ARNI in patients with advanced lung cancer and concurrent hypertension.

Interventions

DRUGARNI

ARNI is prescribed for lung cancer patients with concurrent arterial hypertension

DRUGAnti-hypertensive drugs except ARNI

Anti-hypertensive drugs except ARNI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Able to provide written informed consent (ICF) and able to understand and comply with the study requirements and assessment schedule. * Male or female aged ≥18 years and \< 80years at the time of signing the ICF. * Histologically or cytologically confirmed advanced lung cancer (TNM III-TNM IV) based on the 8th edition of the AJCC staging system * Patients were diagnosed hypertension before the diagnosis of advanced lung cancer * ECOG performance status score ≤ 1. * Adequate organ function during the screening period

Exclusion criteria

* Predicted survival period less than 12 months * Female patients if pregnant. * Hypersensitivity to any component of ARNI * Severe renal dysfunction (eGFR\<30ml/min/1.73m2) * Severe liver dysfunction (Child-Pugh C) * Bilateral renal artery stenosis or solitary renal artery stenosis * Refractory hyperkalemia * Moderate or severe aortic stenolsis * Obstructive hypertrophic cardiomyopathy

Design outcomes

Primary

Measure	Time frame	Description
All-cause mortality	From enrollment to the end of treatment at 24 months	Patients deceased during follow-up regardless of the cause.

Secondary

Measure	Time frame	Description
Major adverse cardiovascular event	From enrollment to the end of treatment at 24 months	Major adverse cardiovascular events include cardiovascular death, hospitalization due to heart failure, acute coronary syndrome, and myocardial infarction.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026