T790M Positive NSCLC Patients
Conditions
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.
Interventions
DRUGosimertinib
Oral dose of 80mg once daily
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 |
| 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 |
Countries
China
Outcome results
None listed