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

NCT07267247 | Completed FDA Drug

• 1 other identifier: VGHTC-CM-MHP-20250918
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Egfr Tyrosine Kinase Inhibitor; Cardiotoxicity; Drug-Related Side Effects and Adverse Reactions (MeSH Term); Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

EGFR-TKI DRUG

Erlotinib, dacomitinib, afatinib, and osimertinib, with dose according to NCCN guide line.

EGFR tyrosine kinase inhibitor OTHER

Erlotinib, dacomitinib, afatinib, and osimertinib, with dose according to NCCN guide line

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• NIL

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Cardiotoxicity

Interventions

EGFR tyrosine kinase inhibitor 324674

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Chest Medicine, Taichung Veterans General Hospital

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: June 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

TW (1)