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

• ClinicalTrials.gov Identifier: NCT03519958
• Recruitment Status: Withdrawn
• First Posted: May 9, 2018
• Last Update Posted: November 16, 2018
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment
Non-small Cell Lung Cancer	Diagnostic Test: Plasma-tissue testing

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Estimated Study Start Date: September 30, 2018
• Estimated Primary Completion Date: November 30, 2020
• Estimated Study Completion Date: November 30, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI

Outcome Measures

Primary Outcome Measures :

1. EGFR T790M mutation prevalance [ Time Frame: 3 years ]
   Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy

Secondary Outcome Measures :

1. Proportion of Valid Tissue T790M Testing Result [ Time Frame: 3 years ]
   Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation
2. T790M Plasma Outcome [ Time Frame: 3 years ]
   Proportions of study subjects who are T790M plasma-negative
3. False Negative Proportation [ Time Frame: 3 years ]
   Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive
4. Reasons for not performing re-biopsy [ Time Frame: 3 years ]
   reasons given for not performing re-biopsy and tissue/cytology testing after obtaining a negative plasma test result
5. Demographics [ Time Frame: Baseline ]
   Demographics of T790M-positive subjects and T790M-negative subjects
6. Disease Characteristics [ Time Frame: 3 years ]
   Disease characteristics of T790M-positive subjects and T790M-negative subjects
7. Number of particapants with complications assoicated with re-biopsy [ Time Frame: 3 years ]
   Number of particapants with complications assoicated with tissue/cytology re-biopsy
8. Clinical Outcomes in T790M plasma-positive subejects [ Time Frame: 3 years ]
   Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive
9. Clinical Outcomes in urine-positive [ Time Frame: 3 years ]
   Clinical outcomes after osimertinib treatment between study subjects who are urine-positive
10. Clinical Outcomes in tissue/cytology-positive [ Time Frame: 3 years ]
    Clinical outcomes after osimertinib treatment between study subjects who are tissue/cytology-positive

Other Outcome Measures:

1. Concordance [ Time Frame: 3 years ]
   To analyze the concordance of T790M mutation status as determined by urine, plasma, and tissue/cytology T790M testing

Biospecimen Retention:   Samples With DNA

Plasma for T7909M ctDNA testing Urine for T7909M ctDNA testing Tissue (optional)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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

Contacts and Locations

Sponsors and Collaborators

AstraZeneca

Investigators

• Principal Investigator: James Ho, MBBS; Queen Mary Hospital, Hong Kong

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT03519958
• Other Study ID Numbers: D5160R00019
• First Posted: May 9, 2018
• Last Update Posted: November 16, 2018
• Last Verified: November 2018

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases