Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Cardiotoxicity; 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
• Intervention / Treatment: Drug: EGFR-TKI; Other: EGFR tyrosine kinase inhibitor

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• patients with advanced or recurrent EGFR-mutant NSCLC receiving EGFR-TKI treatment

Exclusion Criteria:

• NIL

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to 2 years after initiating EGFR tyrosine kinase inhibitor treatment.

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Heart Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Chemically-Induced Disorders; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Pathological Conditions, Signs and Symptoms; Carcinoma, Non-Small-Cell Lung; Cardiotoxicity; EGFR tyrosine kinase inhibitor 324674
• Other Study ID Numbers: VGHTC-CM-MHP-20250918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No