Non-small Cell Lung Cancer
Conditions
Brief summary
To describe the T790M mutation status of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment in a real-world setting.
Detailed description
This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. Eligible patients will be recruited from participating sites in Hong Kong over a 12 months enrolment period. Plasma and urine samples will be collected from enrolled patients. Plasma circulating tumor DNA (ctDNA) and urine ctDNA will be analyzed by droplet digital PCR (ddPCR) for detection of T790M mutation and EGFR sensitizing mutations. Patients who are T790M plasma-negative, regardless of the urine testing results, will be recommended to undergo re-biopsy (defined as tissue sampling or cytology sampling), tissue/cytology T790M testing, and to provide a second plasma sample for a second plasma T790M test (tested by ddPCR). Enrolled patients who subsequently receive osimertinib treatment will be followed up as per routine practice at the investigational site. Patient data will be collected for 12 months or until death or loss to follow-up, whichever occurs earlier, from the first prescription of osimertinib. All clinical decisions will be at the discretion of the treating physician.
Interventions
DIAGNOSTIC_TESTPlasma-tissue testing
EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent * Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy * Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record * Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment * Suggested to undergo T790M mutation testing by treating physician, based on physician judgement
Exclusion criteria
* Had been treated with osimertinib or any other 3rd generation T790M inhibitors * Enrollment in studies that prohibit participation in this observational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EGFR T790M mutation prevalance | 3 years | Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Valid Tissue T790M Testing Result | 3 years | Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation |
| T790M Plasma Outcome | 3 years | Proportions of study subjects who are T790M plasma-negative |
| False Negative Proportation | 3 years | Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive |
| Reasons for not performing re-biopsy | 3 years | reasons given for not performing re-biopsy and tissue/cytology testing after obtaining a negative plasma test result |
| Demographics | Baseline | Demographics of T790M-positive subjects and T790M-negative subjects |
| Disease Characteristics | 3 years | Disease characteristics of T790M-positive subjects and T790M-negative subjects |
| Number of particapants with complications assoicated with re-biopsy | 3 years | Number of particapants with complications assoicated with tissue/cytology re-biopsy |
| Clinical Outcomes in T790M plasma-positive subejects | 3 years | Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive |
| Clinical Outcomes in urine-positive | 3 years | Clinical outcomes after osimertinib treatment between study subjects who are urine-positive |
| Clinical Outcomes in tissue/cytology-positive | 3 years | Clinical outcomes after osimertinib treatment between study subjects who are tissue/cytology-positive |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concordance | 3 years | To analyze the concordance of T790M mutation status as determined by urine, plasma, and tissue/cytology T790M testing |
Outcome results
None listed