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

Non-small Cell Lung Cancer Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219970
• Other study ID #: D5160R00020
• Status: Completed
• Start date: September 5, 2017
• Est. completion date: October 28, 2020

Study information

• Verified date: September 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: October 28, 2020
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Osimertinib
80mg oral daily

Locations

Country	Name	City	State
China	Pamela Youde Nethersole Eastern Hospital	Hong Kong
China	Prince of wales hospital	Hong Kong
China	Queen Mary Hospital	Hong Kong
China	Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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