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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Lung Cancer
• Intervention / Treatment: Drug: Anti-hypertensive drugs except ARNI; Drug: ARNI

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; The patients of this cohort take anti-hypertensive medicine other than ARNI, such as angiotensin receptor blockers, calcium channel blockers, and diuretics.	Drug: Anti-hypertensive drugs except ARNI; Anti-hypertensive drugs except ARNI
Experimental: ARNI group; The patients of this cohort take ARNI as anti-hypertensive medicine.	Drug: ARNI; ARNI is prescribed for lung cancer patients with concurrent arterial hypertension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025IIT-ARNI-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No