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NCT Number: NCT07261098

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

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Key information

Conditions

Advanced Lung Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARNI

Drug

ARNI is prescribed for lung cancer patients with concurrent arterial hypertension

Anti-hypertensive drugs except ARNI

Drug

Anti-hypertensive drugs except ARNI

Primary outcomes

  1. All-cause mortality

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

    Patients deceased during follow-up regardless of the cause.

Secondary outcomes

  1. Major adverse cardiovascular event

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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