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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGFR T790M Patients | Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| osimertinib | Drug | Oral dose of 80mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment | Followed up with 6 months after last patient in |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Followed up 10 months after last subject in |
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Inclusion Criteria:
Exclusion Criteria:
• Enrolment in studies that prohibit any participation in this observational study
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Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed after EGFR TKI treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Yabing Cao | Kiang Wu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kiang Wu Hospital | Macau | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31442277 | Derived | Cao Y, Qiu X, Xiao G, Hu H, Lin T. Effectiveness and safety of osimertinib in patients with metastatic EGFR T790M-positive NSCLC: An observational real-world study. PLoS One. 2019 Aug 23;14(8):e0221575. doi: 10.1371/journal.pone.0221575. eCollection 2019. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
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| T790M mutation testing time | Average turnaround time. | 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 | Followed up 10 months after last patient in |
| Adverse events | To assess by number of adverse events as recorded on the case report form. | 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 | 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. | 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. | 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 | Within 14 days after enrollment date |