Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong

AstraZeneca

Status: Withdrawn

Conditions: Non-small Cell Lung Cancer

Treatments: Diagnostic Test: Plasma-tissue testing

Study type: Observational

Funder types: Industry

Identifiers

NCT03519958

D5160R00019

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

0 participants in 1 patient group

EGFR NSCLC Progressed on EGFR TKI

Description:

Patients with EGFR NSCLC who have progressed following EGFR TKI therapy will undergo plasma-tissue testing

Treatment:

Diagnostic Test: Plasma-tissue testing