An Observational, Multi-centre Study on EGFR T790M Mutation Testing Practices and Outcomes Conducted Among Locally Advanced/Metastatic NSCLC Patients Who Progressed on Previous EGFR Tyrosine-kinase Inhibitor (TKI) Therapy in Hong Kong
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- AstraZeneca
- Primary Endpoint
- EGFR T790M mutation prevalance
Study Overview
Brief Summary
To describe the T790M mutation status of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment in a real-world setting.
Detailed Description
This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. Eligible patients will be recruited from participating sites in Hong Kong over a 12 months enrolment period.
Plasma and urine samples will be collected from enrolled patients. Plasma circulating tumor DNA (ctDNA) and urine ctDNA will be analyzed by droplet digital PCR (ddPCR) for detection of T790M mutation and EGFR sensitizing mutations. Patients who are T790M plasma-negative, regardless of the urine testing results, will be recommended to undergo re-biopsy (defined as tissue sampling or cytology sampling), tissue/cytology T790M testing, and to provide a second plasma sample for a second plasma T790M test (tested by ddPCR).
Enrolled patients who subsequently receive osimertinib treatment will be followed up as per routine practice at the investigational site. Patient data will be collected for 12 months or until death or loss to follow-up, whichever occurs earlier, from the first prescription of osimertinib. All clinical decisions will be at the discretion of the treating physician.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
EGFR T790M mutation prevalance
Time Frame: 3 years
Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy
Secondary Outcomes
- Demographics(Baseline)
- Disease Characteristics(3 years)
- Proportion of Valid Tissue T790M Testing Result(3 years)
- False Negative Proportation(3 years)
- Number of particapants with complications assoicated with re-biopsy(3 years)
- Clinical Outcomes in tissue/cytology-positive(3 years)
- T790M Plasma Outcome(3 years)
- Reasons for not performing re-biopsy(3 years)
- Clinical Outcomes in urine-positive(3 years)
- Clinical Outcomes in T790M plasma-positive subejects(3 years)