Non-small Cell Lung Cancer
Conditions
Brief summary
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
Detailed description
This study will assess the efficacy and safety of single-agent osimertinib in patients with locally advanced or metastatic EGFR T790M-positive NSCLC within the context of the early access program in Hong Kong. In particular, osimertinib treatment efficacy will be assessed in the context of the relationship between EGFR T790M mutant AF and survival outcomes, particularly overall survival. In a real-world setting, analysis of overall survival benefit is considered less sensitive to differences in healthcare systems and standards. Other clinical outcomes including response rate (based on physician's judgement) and time to treatment discontinuation (TTD) will be examined. This study will also describe current practice for molecular testing and EGFR mutation profiles in this patient population.
Interventions
DRUGOsimertinib
80mg oral daily
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients enrolled in AZD9291 Named Patient Program in Hong Kong * Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation * Patients who have previously received EGFR TKI therapy or discontinued an EGFR TKI at the time of enrolment in the study * Provision of written informed consent (for patients alive at the time of study enrolment) * Documented patients with trackable medical records
Exclusion criteria
* Enrolment in studies that prohibit any participation in this non-interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between T790M mutant status and overal survival | Followed up to 2 years after last patient in | To assess the association of EGFR T790M mutant allele fraction (AF) level with the overall survival (OS) of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RR | Follow up within 6 months after last patient in | To estimate response rate (RR) and disease control rate (DCR) based on physician's judgement, for the overall study population. |
| TTD | Followed up to 12 months after last patient in | To estimate time to treatment discontinuation (TTD) of osimertinib for the overall study population, and for subjects with different EGFR mutation status (T790M/Exon 19 del; T790M/L858R) |
| Adverse event of special interest | Followed up to 12 months after last patient in | To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form. |
| Overal survival (OS) | Followed up to 2 years after last patient in | To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib |
| T790M mutation testing platform | Within 14 days after enrollment date | To describe the characteristics of the methods used for T790M mutation testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population |
| EGFR testing mutation subtype | Within 14 days after enrollment date | To describe the EGFR mutation status of study subjects after disease progression on, or discontinuation of, EGFR TKI therapy |
| Treatment pattern | Followed up to 2 years after last patient in | To describe treatment regimens received by study subjects before and after the start of osimertinib therapy. |
| T790M mutation testing sample | Within 14 days after enrollment date | To describe what sample or biopsy collected for testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population |
Countries
China
Outcome results
None listed