Clinical trial NCT03519958: Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enrol locally advanced or metastatic NSCLC patients with confirmed EGFR sensitizing mutation, who progressed after EGFR TKI treatment (i.e.,gefitinib, erlotinib, afatinib), and are suggested to undergo T790M mutation testing by their treating physicians in participating sites in Hong Kong

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.

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

Primary outcomes:
measure: EGFR T790M mutation prevalance
timeFrame: 3 years
Secondary outcomes:
measure: Proportion of Valid Tissue T790M Testing Result
timeFrame: 3 years
measure: T790M Plasma Outcome
timeFrame: 3 years
measure: False Negative Proportation
timeFrame: 3 years
measure: Reasons for not performing re-biopsy
timeFrame: 3 years
measure: Demographics
timeFrame: Baseline
measure: Disease Characteristics
timeFrame: 3 years
measure: Number of particapants with complications assoicated with re-biopsy
timeFrame: 3 years
measure: Clinical Outcomes in T790M plasma-positive subejects
timeFrame: 3 years
measure: Clinical Outcomes in urine-positive
timeFrame: 3 years
measure: Clinical Outcomes in tissue/cytology-positive
timeFrame: 3 years
Other outcomes:
measure: Concordance
timeFrame: 3 years
Locations:
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: James Ho, MBBS
role: PRINCIPAL_INVESTIGATOR
References: