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

NCT ID: NCT03519958

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2020-11-30

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EGFR NSCLC Progressed on EGFR TKI

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

Plasma-tissue testing

Intervention Type: DIAGNOSTIC_TEST

EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI

Interventions

Plasma-tissue testing

EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Ho, MBBS

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, Hong Kong

Other Identifiers

D5160R00019

Identifier Type: -

Identifier Source: org_study_id