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

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ClinicalTrials.gov Identifier: NCT03519958
Recruitment Status : Withdrawn (The study direction does not longer aligns the sponsor's strategy)
First Posted : May 9, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.


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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

Resource links provided by the National Library of Medicine


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




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)


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519958


Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: James Ho, MBBS Queen Mary Hospital, Hong Kong

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03519958     History of Changes
Other Study ID Numbers: D5160R00019
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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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