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

Phase 2Not Yet RecruitingNCT07261098

Shanghai Chest Hospital200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

Advanced Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

All-cause mortality

Patients deceased during follow-up regardless of the cause.

Time frame: From enrollment to the end of treatment at 24 months

Secondary Outcomes

Major adverse cardiovascular event

Major adverse cardiovascular events include cardiovascular death, hospitalization due to heart failure, acute coronary syndrome, and myocardial infarction.

Time frame: From enrollment to the end of treatment at 24 months