Clinical trial NCT03219970: Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed or discontinued from previous EGFR TKI treatment.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between T790M mutant status and overal survival
timeFrame: Followed up to 2 years after last patient in
Secondary outcomes:
measure: Overal survival (OS)
timeFrame: Followed up to 2 years after last patient in
measure: RR
timeFrame: Follow up within 6 months after last patient in
measure: TTD
timeFrame: Followed up to 12 months after last patient in
measure: Adverse event of special interest
timeFrame: Followed up to 12 months after last patient in
measure: T790M mutation testing sample
timeFrame: Within 14 days after enrollment date
measure: T790M mutation testing platform
timeFrame: Within 14 days after enrollment date
measure: EGFR testing mutation subtype
timeFrame: Within 14 days after enrollment date
measure: Treatment pattern
timeFrame: Followed up to 2 years after last patient in
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: China
facility: Prince of wales hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Hong Kong
country: China
facility: Tuen Mun Hospital
Study officials:
affiliation: Pamela Youde Nethersole Eastern Hospital
name: Siu Hong, Oscar CHAN
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital
name: Kwok Chi LAM
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Mary Hospital, Hong Kong
name: Ho Fun, Victor LEE
role: PRINCIPAL_INVESTIGATOR
affiliation: Tuen Mun Hospital
name: Shi Feng NYAW
role: PRINCIPAL_INVESTIGATOR
References: