Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC

Study Overview
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Brief Summary
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To assess the effectiveness and safety of osimertinib treatment in a real world setting.

Detailed Description
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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.

Official Title
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An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).

Conditions
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T790M Positive NSCLC Patients

Intervention / Treatment
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* Drug: osimertinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: • Enrolment in studies that prohibit any participation in this observational study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EGFR T790M Patients<br>Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI | Drug: osimertinib<br>* Oral dose of 80mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |