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Heart monitoring during lung cancer therapy may save lives

NCT ID NCT04980716

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether early heart monitoring and medication can prevent heart problems in people with advanced lung cancer receiving chemoradiotherapy and immunotherapy. About 524 participants will be randomly assigned to receive either standard care or additional heart-focused treatment guided by a special monitoring device. The goal is to see if this approach improves survival and reduces heart-related side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cardiovascular drugs (Golden Triangle therapy)
What this could lead to
If successful, this approach could reduce heart complications and improve survival for lung cancer patients receiving aggressive cancer therapy.
What could go wrong
This is a large phase III trial, but the intervention is complex and may not significantly improve outcomes. Heart drugs also carry their own side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 524 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging; 2. Plan to receive radical radiotherapy and chemotherapy ± immunotherapy; 3. Male or female between 18 and 75 years old; 4. Life expectancy ≥ 12 weeks; 5. The World Health Organization (WHO) PS score is 0 or 1; 6. Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN; 7. A signed informed consent form is required before proceeding with any step in the research; 8. There is an abnormality in the initial cardiac output index. Exclusion Criteria: 1. PS score 2-4; 2. Organ function impairment: FEV1 \<1000ml; absolute neutrophil count \<1.5×10\^9/L; platelets \<100×10\^9/L; hemoglobin \<90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula \<50 mL/min; serum bilirubin\>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase\>2.5 times ULN; 3. Unstable angina or myocardial infarction occurred in the past month; 4. Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics; 5. Active endocarditis; 6. Symptomatic severe aortic stenosis; 7. Heart failure that has not been controlled; 8. Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation; 9. Suspected or confirmed aortic dissection; 10. Uncontrolled bronchial asthma; 11. Pulmonary edema; 12. Fingertip blood oxygen saturation at rest ≤85%; 13. Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise; 14. Mental disorders make it impossible to cooperate. 15. Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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