Epidermal Growth Factor Receptor (EGFR) T790M Mutation Te... | NCT03519958

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

NCT03519958

Sponsor

AstraZeneca

Status

Withdrawn

Last Update Posted

Nov 16, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

Interventions

Plasma-tissue testing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study direction does not longer aligns the sponsor's strategy

Expanded Access Info

Start Date

Sep 30, 2018Estimated

Primary Completion Date

Nov 30, 2020Estimated

Completion Date

Nov 30, 2020Estimated

First Submitted Date

Feb 19, 2018

First Submission Date that Met QC Criteria

Apr 30, 2018

First Posted Date

May 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2018

Last Update Posted Date

Nov 16, 2018Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EGFR NSCLC Progressed on EGFR TKI		Patients with EGFR NSCLC who have progressed following EGFR TKI therapy will undergo plasma-tissue testing	Diagnostic Test: Plasma-tissue testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasma-tissue testing	Diagnostic Test	EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI	EGFR NSCLC Progressed on EGFR TKI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EGFR T790M mutation prevalance	Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy	3 years

Secondary Outcomes

Measure	Description	Time Frame
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
T790M Plasma Outcome

Other Outcomes

Measure	Description	Time Frame
Concordance	To analyze the concordance of T790M mutation status as determined by urine, plasma, and tissue/cytology T790M testing	3 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
James Ho, MBBS	Queen Mary Hospital, Hong Kong	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

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