Non-small Cell Lung CancerNCT05997719
Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC
An observational study of Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
To investigate genomic architecture, cancer evolution and their relationship with clinical outcomes in EGFR-mutant NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically or cytologically confirmed EGFR-mutant NSCLC
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guanzhou, 510060
Li Zhang, MD., 86 20 87343366, zhangli@sysucc.org.cn
About this study
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.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- EGFR mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start10 Aug 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997719
- Sponsor's protocol ID
- B2023-287-01
- Status last verified
- Oct 2023
- First submitted
- 3 Aug 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC
- ClinicalTrials.gov ID
- NCT05997719
- Acronym / sponsor ID
- B2023-287-01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- EGFR mutation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically confirmed EGFR-mutant NSCLC
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Clinical utility of ctDNA in EGFR-mutant NSCLC
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shen Zhao, MD. (86 20 87343366, zhaoshen@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intratumor heterogeneity (ITH) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.