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Not yet recruitingNCT07261098Updated Dec 3, 2025

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

A Phase 2 interventional study of ARNI and Anti-hypertensive drugs except ARNI in Advanced Lung Cancer, sponsored by Shanghai Chest Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Shanghai Chest Hospital · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Lung Cancer
03

In context

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • Experimental
    ARNI group

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

    Drug: ARNI

Interventions

  • DrugARNI

    ARNI is prescribed for lung cancer patients with concurrent arterial hypertension

  • DrugAnti-hypertensive drugs except ARNI

    Anti-hypertensive drugs except ARNI

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07261098
Lead sponsor
Shanghai Chest Hospital
Responsible party
Liang Zhao (Professor, Shanghai Chest Hospital) — Principal investigator
First posted
Dec 3, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Dec 3, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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