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Recruiting

NCT Number: NCT05997719

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guanzhou, 510060, China

Location status: Recruiting

Location contact

Li Zhang, MD.

CONTACT

[email protected]

86 20 87343366

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).
  • Unable to provide sufficient tumor tissue for analysis.
  • 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.
  • Subjects who are deemed unable to comply with the study requirements or complete the study.

Treatment and study plan

Primary outcomes

  1. Intratumor heterogeneity (ITH)

    Time frame: 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 outcomes

  1. Clinical utility of ctDNA in EGFR-mutant NSCLC

    Time frame: 5 years

    Clinical utility of ctDNA in dissecting ITH, and its relationship with clinical features and clinical outcomes in EGFR-mutant NSCLC

Study contacts

Contact information is provided by the study sponsor or research team.

Shen Zhao, MD.

CONTACT

[email protected]

86 20 87343366

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Aug 18, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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