Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Diagnostic Test: Plasma-tissue testing
- Registration Number
- NCT03519958
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EGFR NSCLC Progressed on EGFR TKI Plasma-tissue testing Patients with EGFR NSCLC who have progressed following EGFR TKI therapy will undergo plasma-tissue testing
- Primary Outcome Measures
Name Time Method EGFR T790M mutation prevalance 3 years Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy
- Secondary Outcome Measures
Name Time Method Demographics Baseline Demographics of T790M-positive subjects and T790M-negative subjects
Disease Characteristics 3 years Disease characteristics of T790M-positive subjects and T790M-negative subjects
Proportion of Valid Tissue T790M Testing Result 3 years Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation
False Negative Proportation 3 years Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive
Number of particapants with complications assoicated with re-biopsy 3 years Number of particapants with complications assoicated with tissue/cytology re-biopsy
Clinical Outcomes in tissue/cytology-positive 3 years Clinical outcomes after osimertinib treatment between study subjects who are tissue/cytology-positive
T790M Plasma Outcome 3 years Proportions of study subjects who are T790M plasma-negative
Reasons for not performing re-biopsy 3 years reasons given for not performing re-biopsy and tissue/cytology testing after obtaining a negative plasma test result
Clinical Outcomes in urine-positive 3 years Clinical outcomes after osimertinib treatment between study subjects who are urine-positive
Clinical Outcomes in T790M plasma-positive subejects 3 years Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive