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

Non-small Cell Lung Cancer Clinical Trial

Official title:

An Observational, Multi-centre Study on EGFR T790M Mutation Testing Practices and Outcomes Conducted Among Locally Advanced/Metastatic NSCLC Patients Who Progressed on Previous EGFR Tyrosine-kinase Inhibitor (TKI) Therapy in Hong Kong

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03519958
• Other study ID #: D5160R00019
• Status: Withdrawn
• Start date: September 30, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Diagnostic Test:
• Plasma-tissue testing
EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concordance	To analyze the concordance of T790M mutation status as determined by urine, plasma, and tissue/cytology T790M testing	3 years
Primary	EGFR T790M mutation prevalance	Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy	3 years
Secondary	Proportion of Valid Tissue T790M Testing Result	Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation	3 years
Secondary	T790M Plasma Outcome	Proportions of study subjects who are T790M plasma-negative	3 years
Secondary	False Negative Proportation	Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive	3 years
Secondary	Reasons for not performing re-biopsy	reasons given for not performing re-biopsy and tissue/cytology testing after obtaining a negative plasma test result	3 years
Secondary	Demographics	Demographics of T790M-positive subjects and T790M-negative subjects	Baseline
Secondary	Disease Characteristics	Disease characteristics of T790M-positive subjects and T790M-negative subjects	3 years
Secondary	Number of particapants with complications assoicated with re-biopsy	Number of particapants with complications assoicated with tissue/cytology re-biopsy	3 years
Secondary	Clinical Outcomes in T790M plasma-positive subejects	Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive	3 years
Secondary	Clinical Outcomes in urine-positive	Clinical outcomes after osimertinib treatment between study subjects who are urine-positive	3 years
Secondary	Clinical Outcomes in tissue/cytology-positive	Clinical outcomes after osimertinib treatment between study subjects who are tissue/cytology-positive	3 years