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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 2

Conditions: Advanced Lung Cancer

Treatments: Drug: ARNI; Drug: Anti-hypertensive drugs except ARNI

Study type: Interventional

Funder types: Other

Identifiers

NCT07261098

2025IIT-ARNI-0001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Control group

Active Comparator group

Description:

The patients of this cohort take anti-hypertensive medicine other than ARNI, such as angiotensin receptor blockers, calcium channel blockers, and diuretics.

Treatment:

Drug: Anti-hypertensive drugs except ARNI

ARNI group

Experimental group

Description:

The patients of this cohort take ARNI as anti-hypertensive medicine.

Treatment:

Drug: ARNI