Advanced Lung CancerPhase 2NCT07261098
The Efficacy and Safety of ARNI on the Outcome of Advanced Lung Cancer With Concurrent Hypertension
A Phase 2 study testing ARNI and Anti-hypertensive drugs except ARNI in people with Advanced Lung Cancer, run by Shanghai Chest Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- ARNI and Anti-hypertensive drugs except ARNI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Refractory hyperkalemia
- Moderate or severe aortic stenolsis
- Obstructive hypertrophic cardiomyopathy
About this study
Official title: A Prospective Study of the Efficacy and Safety of Angiotensin Receptor-neprilysin Inhibitor in Patients With Advanced Lung Cancer and 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.
- Conditions
- Advanced Lung Cancer
- Being tested
- ARNI, Anti-hypertensive drugs except ARNI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARNIDrug
ARNI is prescribed for lung cancer patients with concurrent arterial hypertension
Anti-hypertensive drugs except ARNIDrug
Anti-hypertensive drugs except ARNI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anti-hypertensive drugs except ARNI |
| ARNI group | Experimental | The patients of this cohort take ARNI as anti-hypertensive medicine. Receives: Drug: ARNI |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Patients deceased during follow-up regardless of the cause.
Measured: 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.
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Zhao, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261098
- Sponsor's protocol ID
- 2025IIT-ARNI-0001
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Efficacy and Safety of Angiotensin Receptor-neprilysin Inhibitor in Patients With Advanced Lung Cancer and Concurrent Hypertension
- ClinicalTrials.gov ID
- NCT07261098
- Acronym / sponsor ID
- 2025IIT-ARNI-0001
- Conditions
- Advanced Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Anti-hypertensive drugs except ARNIThe patients of this cohort take anti-hypertensive medicine other than ARNI, such as angiotensin receptor blockers, calcium channel blockers, and diuretics. |
| ARNI group | Experimental | Drug: ARNIThe patients of this cohort take ARNI as anti-hypertensive medicine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARNIARNI is prescribed for lung cancer patients with concurrent arterial hypertension | Drug | ARNI group |
| Anti-hypertensive drugs except ARNIAnti-hypertensive drugs except ARNI | Drug | Control group |
Primary outcome
All-cause mortality
Time frame: From enrollment to the end of treatment at 24 months
Patients deceased during follow-up regardless of the cause.
1 secondary outcome
Major adverse cardiovascular event
Time frame: From enrollment to the end of treatment at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARNI and Anti-hypertensive drugs except ARNI in people with Advanced Lung Cancer, run by Shanghai Chest Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: From enrollment to the end of treatment at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.