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

NCT07261098 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025IIT-ARNI-0001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Patients deceased during follow-up regardless of the cause.

  From enrollment to the end of treatment at 24 months

Secondary Outcomes (1)

• Major adverse cardiovascular event

  From enrollment to the end of treatment at 24 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

ARNI group

EXPERIMENTAL

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

Drug: ARNI

Interventions

ARNI DRUG

ARNI is prescribed for lung cancer patients with concurrent arterial hypertension

ARNI group

Anti-hypertensive drugs except ARNI DRUG

Anti-hypertensive drugs except ARNI

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11