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

NCT ID: NCT05997719

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2030-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang, MD

Chief of Medical Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guanzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shen Zhao, MD.

Role: CONTACT

zhaoshen@sysucc.org.cn

86 20 87343366

Facility Contacts

Li Zhang, MD.

Role: primary

zhangli@sysucc.org.cn

86 20 87343366

Other Identifiers

B2023-287-01

Identifier Type: -

Identifier Source: org_study_id