Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)NCT07267247
Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer
An observational study of Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung) and Drug-Related Side Effects and Adverse Reactions (MeSH Term), run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This study investigated the incidence of cardiac dysfunction in patients with advanced or recurrent epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer treated with EGFR- tyrosine kinase inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), Drug-Related Side Effects and Adverse Reactions (MeSH Term), Egfr Tyrosine Kinase Inhibitor
- What is being tested?
- EGFR-TKI and EGFR tyrosine kinase inhibitor
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations, who are prescribed EGFR tyrosine kinase inhibitors (gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib) as part of routine clinical care at Taichung Veterans General Hospital. All participants will undergo echocardiographic assessment at baseline and follow-up time points according to the study protocol.
Who may be able to join
- patients with advanced or recurrent EGFR-mutant NSCLC receiving EGFR-TKI treatment
Who cannot join
- NIL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer: A Single-center Prospective Observational Study
This study investigated the incidence of cardiac dysfunction in patients with advanced or recurrent epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer treated with EGFR- tyrosine kinase inhibitors.
- Conditions
- Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), Drug-Related Side Effects and Adverse Reactions (MeSH Term), Egfr Tyrosine Kinase Inhibitor, Cardiotoxicity
- Being tested
- EGFR-TKI, EGFR tyrosine kinase inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR-TKIDrug
Erlotinib, dacomitinib, afatinib, and osimertinib, with dose according to NCCN guide line.
EGFR tyrosine kinase inhibitorOther
Erlotinib, dacomitinib, afatinib, and osimertinib, with dose according to NCCN guide line
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cancer therapy-related cardiac dysfunction after treatment with EGFR tyrosine kinase inhibitors.
Cancer therapy-related cardiac dysfunction was defined as a left ventricular ejection fraction of less than 50% and an absolute reduction in LVEF of more than 10% from baseline.
Measured: From enrollment to 2 years after initiating EGFR tyrosine kinase inhibitor treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Jun 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)Studies of the same condition, open and under way.
- More trials run by Taichung Veterans General 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mu Han, Peng, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267247
- Sponsor's protocol ID
- VGHTC-CM-MHP-20250918
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer: A Single-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07267247
- Acronym / sponsor ID
- VGHTC-CM-MHP-20250918
- Conditions
- Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), Drug-Related Side Effects and Adverse Reactions (MeSH Term), Egfr Tyrosine Kinase Inhibitor, Cardiotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 5 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.
This study investigated the incidence of cardiac dysfunction in patients with advanced or recurrent epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer treated with EGFR- tyrosine kinase inhibitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations, who are prescribed EGFR tyrosine kinase inhibitors (gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib) as part of routine clinical care at Taichung Veterans General Hospital. All participants will undergo echocardiographic assessment at baseline and follow-up time points according to the study protocol.
Key inclusion criteria (1 listed)
- patients with advanced or recurrent EGFR-mutant NSCLC receiving EGFR-TKI treatment
Key exclusion criteria (1 listed)
- NIL
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 |
|---|---|---|
| EGFR-TKIErlotinib, dacomitinib, afatinib, and osimertinib, with dose according to NCCN guide line. | Drug | – |
| EGFR tyrosine kinase inhibitorErlotinib, dacomitinib, afatinib, and osimertinib, with dose according to NCCN guide line | Other | – |
Primary outcome
The incidence of cancer therapy-related cardiac dysfunction after treatment with EGFR tyrosine kinase inhibitors.
Time frame: From enrollment to 2 years after initiating EGFR tyrosine kinase inhibitor treatment.
Cancer therapy-related cardiac dysfunction was defined as a left ventricular ejection fraction of less than 50% and an absolute reduction in LVEF of more than 10% from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung) and Drug-Related Side Effects and Adverse Reactions (MeSH Term), run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of cancer therapy-related cardiac dysfunction after treatment with EGFR tyrosine kinase inhibitors. (time frame: From enrollment to 2 years after initiating EGFR tyrosine kinase inhibitor treatment.). 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 5 Dec 2025.