SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03219970

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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.

NCT03219970 Non-small Cell Lung Cancer
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: Osimertinib

Description: 80mg oral daily

Type: Drug

EGFR T790M positive NSCLC patients


Primary Outcomes

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 in

Secondary Outcomes

Description: 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 in

Description: 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 in

Description: 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 in

Description: 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 in

Description: 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 date

Description: 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 date

Description: 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 date

Description: 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 in

Time Perspective: Retrospective

Cohort


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1