Heart monitoring during lung cancer therapy may save lives
NCT ID NCT04980716
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 524 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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- Can PET scan signals predict who beats lung cancer with immunotherapy?