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RecruitingNCT05997719Updated Oct 24, 2023

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

An observational study in Non-small Cell Lung Cancer, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-24.

Sponsored by Sun Yat-sen University · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • EGFR mutation
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 150 is close to the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Histologically or cytologically confirmed EGFR-mutant NSCLC

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Intratumor heterogeneity (ITH)

    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

    Time frame: 5 years

Secondary outcomes

  1. Clinical utility of ctDNA in EGFR-mutant NSCLC

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

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guanzhou, 510060, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05997719
Lead sponsor
Sun Yat-sen University
Responsible party
Li Zhang, MD (Chief of Medical Oncology Department, Sun Yat-sen University) — Principal investigator
First posted
Aug 18, 2023
Start date
Aug 10, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Oct 24, 2023

Study contacts

Shen Zhao, MD.
Contact
zhaoshen@sysucc.org.cn
86 20 87343366

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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