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

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.

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

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Osimertinib

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Prince of Wales Hospital
  • Hong Kong, China
    • Queen Mary Hospital
  • Hong Kong, China
    • Tuen Mun Hospital
  • Hong Kong, China
    • Pamela Youde Nethersole Eastern Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed or discontinued from previous EGFR TKI treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EGFR T790M positive NSCLC patients; Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment.	Drug: Osimertinib; 80mg oral daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between T790M mutant status and overal survival	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	Followed up to 2 years after last patient in

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overal survival (OS)	To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib	Followed up to 2 years after last patient in
RR	To estimate response rate (RR) and disease control rate (DCR) based on physician's judgement, for the overall study population.	Follow up within 6 months after last patient in
TTD	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)	Followed up to 12 months after last patient in
Adverse event of special interest	To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form.	Followed up to 12 months after last patient in
T790M mutation testing sample	To describe what sample or biopsy collected for testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population	Within 14 days after enrollment date
T790M mutation testing platform	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	Within 14 days after enrollment date
EGFR testing mutation subtype	To describe the EGFR mutation status of study subjects after disease progression on, or discontinuation of, EGFR TKI therapy	Within 14 days after enrollment date
Treatment pattern	To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.	Followed up to 2 years after last patient in

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Siu Hong, Oscar CHAN, Pamela Youde Nethersole Eastern Hospital; Principal Investigator: Kwok Chi LAM, Prince of Wales Hospital; Principal Investigator: Ho Fun, Victor LEE, Queen Mary Hospital, Hong Kong; Principal Investigator: Shi Feng NYAW, Tuen Mun Hospital

Publications and helpful links

Helpful Links

• Redacted Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): October 28, 2020
• Study Completion (Actual): October 28, 2020

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: D5160R00020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.