Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC

Recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT05997719
• Lead Sponsor: Sun Yat-sen University

Brief Summary

To investigate genomic architecture, cancer evolution and their relationship with clinical outcomes in EGFR-mutant NSCLC.

Detailed Description

EGFR mutations are detected in about 50% of East Asian NSCLC and 10% of Western NSCLC. EGFR-mutant NSCLC harbors distinct genomic architecture including high ITH, early diversification, genome instability, low background mutation rates. But despite its high ITH, EGFR-mutant NSCLC usually have better prognosis than NSCLC with other driver mutations even without the application of targeted therapies, indicating that EGFR mutations may have distinct impacts on cancer evolution. This study intends to investigate the genomic architecture, cancer evolution trajectories and their relationship with clinical outcomes in EGFR-mutant NSCLC, and to identify prognostic and predictive biomarkers for this population that could potentially guide therapeutic decisions and improved clinical outcomes.

Study Timeline

• Study First Submitted: 2023-08-03
• Study Start: 2023-08-10
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-24
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Aged 18 years or older
2. Histologically or cytologically confirmed non-small-cell lung cancer
3. ECOG PS=0-2
4. EGFR mutations confirmed by tissue or peripheral blood
5. Can provide tumor tissue samples (fresh or archived)
6. The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent

Exclusion Criteria

1. History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).
2. Unable to provide sufficient tumor tissue for analysis.
3. Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.
4. Subjects who are deemed unable to comply with the study requirements or complete the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intratumor heterogeneity (ITH)	5 years	Intratumor heterogeneity in terms of genomic architecture, transcriptomic profiles and clonal composition; Investigate the relationship between ITH, clinical features and clinical outcomes in EGFR-mutant NSCLC

Secondary Outcome Measures

Name	Time	Method
Clinical utility of ctDNA in EGFR-mutant NSCLC	5 years	Clinical utility of ctDNA in dissecting ITH, and its relationship with clinical features and clinical outcomes in EGFR-mutant NSCLC

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guanzhou, China