To assess the effectiveness and safety of osimertinib treatment in a real world setting.
The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.
Study Type
OBSERVATIONAL
Enrollment
47
Oral dose of 80mg once daily
Kiang Wu Hospital
Macau, China
ORR
Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment
Time frame: Followed up with 6 months after last patient in
PFS
Progression free survival (PFS), defined as the time from the date of first dose of osimertinib to the date of investigator-assessed disease progression or death from any cause during study. Subjects who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment
Time frame: Followed up 10 months after last subject in
T790M mutation testing time
Average turnaround time.
Time frame: Within 14 days after enrollment date
Treatment patterns
To assess by number of previous adopted/current/future therapies as recorded on the case report form
Time frame: Followed up 10 months after last patient in
Adverse events
To assess by number of adverse events as recorded on the case report form.
Time frame: Follow up 10 months after last patient in.
Adverse event intensity
To assess by intensity of adverse events as recorded on the case report form, which will be measured by CTCAE grade system
Time frame: Follow up 10 months after last patient in.
T790M mutation testing sample
To assess by proportion of testing samples types as recorded on the case report form.
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Time frame: Within 14 days after enrollment date
T790M mutation testing platform
To assess by proportion of each testing platform as recorded on the case report form.
Time frame: Within 14 days after enrollment date
EGFR testing mutation subtype
To assess by proportion of EGFR mutation subtype as recorded on the case report form
Time frame: Within 14 days after enrollment date