Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC
- Registration Number
- NCT03133234
- Lead Sponsor
- AstraZeneca
- Brief Summary
To assess the effectiveness and safety of osimertinib treatment in a real world setting.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Above 18 years of age;
- Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
- Confirmed T790M mutation
- Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment
- Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016
• Enrolment in studies that prohibit any participation in this observational study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EGFR T790M Patients osimertinib Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI
- Primary Outcome Measures
Name Time Method ORR Followed up with 6 months after last patient in Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment
- Secondary Outcome Measures
Name Time Method PFS Followed up 10 months after last subject in 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
T790M mutation testing time Within 14 days after enrollment date Average turnaround time.
Treatment patterns Followed up 10 months after last patient in To assess by number of previous adopted/current/future therapies as recorded on the case report form
Adverse events Follow up 10 months after last patient in. To assess by number of adverse events as recorded on the case report form.
Adverse event intensity Follow up 10 months after last patient in. To assess by intensity of adverse events as recorded on the case report form, which will be measured by CTCAE grade system
T790M mutation testing sample Within 14 days after enrollment date To assess by proportion of testing samples types as recorded on the case report form.
T790M mutation testing platform Within 14 days after enrollment date To assess by proportion of each testing platform as recorded on the case report form.
EGFR testing mutation subtype Within 14 days after enrollment date To assess by proportion of EGFR mutation subtype as recorded on the case report form
Trial Locations
- Locations (1)
Kiang Wu Hospital
🇨🇳Macau, China