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Report for Clinical Trial NCT02777567

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or After EGFR Tyrosine Kinase Receptor (TKI) Therapy

The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.

NCT02777567 Non-Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma


Primary Outcomes

Description: Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

Measure: Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

Time: up to one year

Description: Severity of (S)AEs

Measure: Severity of (S)AEs

Time: up to one year

Secondary Outcomes

Description: ORR (Objective response rate), if available

Measure: ORR (Objective response rate), if available

Time: up to one year

Description: PFS (Progression free survival), if available

Measure: PFS (Progression free survival), if available

Time: up to one year

Time Perspective: Prospective

Case-Only


There is one SNP

SNPs


1 T790M

Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or After EGFR Tyrosine Kinase Receptor (TKI) Therapy. --- T790M ---

KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy) The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy. --- T790M ---

Inclusion Criteria: - 1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy - 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: - 1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug - 2. Pregnancy and/or breast feeding - 3. Current participation in any interventional trial Inclusion Criteria: - 1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy - 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: - 1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug - 2. Pregnancy and/or breast feeding - 3. Current participation in any interventional trial Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- T790M ---

Inclusion Criteria: - 1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy - 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: - 1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug - 2. Pregnancy and/or breast feeding - 3. Current participation in any interventional trial Inclusion Criteria: - 1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy - 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: - 1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug - 2. Pregnancy and/or breast feeding - 3. Current participation in any interventional trial Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- T790M --- --- T790M ---



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