SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02777567

Developed by Shray Alag, 2019.
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 ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1