To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
Name: Osimertinib
Description: 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
Measure: Association between T790M mutant status and overal survival Time: Followed up to 2 years after last patient inDescription: To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
Measure: Overal survival (OS) Time: Followed up to 2 years after last patient inDescription: To estimate response rate (RR) and disease control rate (DCR) based on physician's judgement, for the overall study population.
Measure: RR Time: Follow up within 6 months after last patient inDescription: 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)
Measure: TTD Time: Followed up to 12 months after last patient inDescription: To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form.
Measure: Adverse event of special interest Time: Followed up to 12 months after last patient inDescription: To describe what sample or biopsy collected for testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population
Measure: T790M mutation testing sample Time: Within 14 days after enrollment dateDescription: 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
Measure: T790M mutation testing platform Time: Within 14 days after enrollment dateDescription: To describe the EGFR mutation status of study subjects after disease progression on, or discontinuation of, EGFR TKI therapy
Measure: EGFR testing mutation subtype Time: Within 14 days after enrollment dateDescription: To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.
Measure: Treatment pattern Time: Followed up to 2 years after last patient inCohort
There is one SNP
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.. Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting. --- T790M ---
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.. Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting. --- T790M --- --- T790M ---
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting. --- T790M ---
Association between T790M mutant status and overal survival. --- T790M ---
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. --- T790M ---
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. --- T790M --- --- T790M ---
To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib. --- T790M ---
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). --- T790M ---
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). --- T790M --- --- T790M ---
To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form.. T790M mutation testing sample. --- T790M ---
T790M mutation testing platform. --- T790M ---
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. --- T790M ---
To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.. 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 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 Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung 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. --- T790M ---
To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.. 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 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 Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung 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. --- T790M --- --- T790M ---
To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.. 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 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 Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung 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. --- T790M --- --- T790M --- --- T790M ---
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. --- T790M ---