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Completed

NCT Number: NCT03219970

Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.

To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamela Youde Nethersole Eastern Hospital, Hong Kong, China

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About this study

This study will assess the efficacy and safety of single-agent osimertinib in patients with locally advanced or metastatic EGFR T790M-positive NSCLC within the context of the early access program in Hong Kong. In particular, osimertinib treatment efficacy will be assessed in the context of the relationship between EGFR T790M mutant AF and survival outcomes, particularly overall survival. In a real-world setting, analysis of overall survival benefit is considered less sensitive to differences in healthcare systems and standards. Other clinical outcomes including response rate (based on physician's judgement) and time to treatment discontinuation (TTD) will be examined. This study will also describe current practice for molecular testing and EGFR mutation profiles in this patient population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients enrolled in AZD9291 Named Patient Program in Hong Kong
  • Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation
  • Patients who have previously received EGFR TKI therapy or discontinued an EGFR TKI at the time of enrolment in the study
  • Provision of written informed consent (for patients alive at the time of study enrolment)
  • Documented patients with trackable medical records

Exclusion criteria

  • Enrolment in studies that prohibit any participation in this non-interventional study

Treatment and study plan

Osimertinib

Drug

80mg oral daily

Primary outcomes

  1. Association between T790M mutant status and overal survival

    Time frame: Followed up to 2 years after last patient in

    To assess the association of EGFR T790M mutant allele fraction (AF) level with the overall survival (OS) of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib

Secondary outcomes

  1. Overal survival (OS)

    Time frame: Followed up to 2 years after last patient in

    To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib

  2. RR

    Time frame: Follow up within 6 months after last patient in

    To estimate response rate (RR) and disease control rate (DCR) based on physician's judgement, for the overall study population.

  3. TTD

    Time frame: Followed up to 12 months after last patient in

    To estimate time to treatment discontinuation (TTD) of osimertinib for the overall study population, and for subjects with different EGFR mutation status (T790M/Exon 19 del; T790M/L858R)

  4. Adverse event of special interest

    Time frame: Followed up to 12 months after last patient in

    To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form.

  5. T790M mutation testing sample

    Time frame: Within 14 days after enrollment date

    To describe what sample or biopsy collected for testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population

  6. T790M mutation testing platform

    Time frame: Within 14 days after enrollment date

    To describe the characteristics of the methods used for T790M mutation testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population

  7. EGFR testing mutation subtype

    Time frame: Within 14 days after enrollment date

    To describe the EGFR mutation status of study subjects after disease progression on, or discontinuation of, EGFR TKI therapy

  8. Treatment pattern

    Time frame: Followed up to 2 years after last patient in

    To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Observational, Non-interventional, Multi-center, Chart Review Study Conducted Among Patients Enrolled in an AZD9291 Early Access Program in Hong Kong, With Locally Advanced/Metastatic EGFR T790M Mutation-positive NSCLC and Prior Exposure to EGFR TKI Therapy.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2017
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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