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.
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 Type
OBSERVATIONAL
EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI
EGFR T790M mutation prevalance
Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy
Time frame: 3 years
Proportion of Valid Tissue T790M Testing Result
Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation
Time frame: 3 years
T790M Plasma Outcome
Proportions of study subjects who are T790M plasma-negative
Time frame: 3 years
False Negative Proportation
Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive
Time frame: 3 years
Reasons for not performing re-biopsy
reasons given for not performing re-biopsy and tissue/cytology testing after obtaining a negative plasma test result
Time frame: 3 years
Demographics
Demographics of T790M-positive subjects and T790M-negative subjects
Time frame: Baseline
Disease Characteristics
Disease characteristics of T790M-positive subjects and T790M-negative subjects
Time frame: 3 years
Number of particapants with complications assoicated with re-biopsy
Number of particapants with complications assoicated with tissue/cytology re-biopsy
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Time frame: 3 years
Clinical Outcomes in T790M plasma-positive subejects
Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive
Time frame: 3 years
Clinical Outcomes in urine-positive
Clinical outcomes after osimertinib treatment between study subjects who are urine-positive
Time frame: 3 years
Clinical Outcomes in tissue/cytology-positive
Clinical outcomes after osimertinib treatment between study subjects who are tissue/cytology-positive
Time frame: 3 years