The aim of this study is to assess the efficacy and safety of single agent AZD9291 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 received prior EGFR-tyrosine kinase inhibitor (TKI) therapy.
Name: T790M+ Testing
Description: If a previous lab report is unavailable, the patient will need to have T790M+ testing.Type: ProcedureAZD9291
Name: Baseline Visit Blood & Urine Testing
Description: Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteriaType: ProcedureAZD9291
Name: Baseline ECG
Description: ECG to ensure absence of any cardiac abnormalityType: ProcedureAZD9291
Name: Visual Slit-Lamp Testing
Description: Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptomsType: ProcedureAZD9291
Name: AZD9291 Dosing
Description: Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)Type: DrugAZD9291
Description: Efficacy will be measured by the analysis of Overall Survival defined as the date of 1st dose until date of death.
Measure: Efficacy of AZD9291 by the analysis of overall survival. Time: From first dose intake to end of study (Last subject last visit (LSLV)) (up to approximately 24 months)Description: PFS will be summarized using Kaplan-Meier estimates of the median time to progression or death and quartiles with their 95% confidence intervals.
Measure: Efficacy of AZD9291 by the analysis of Progression Free Survival (PFS) Time: from first dose intake to progression or death.Single Group Assignment
There is one SNP
Open Label, Multinational, Multicenter, Real World Treatment Study of Single Agent AZD9291 for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Prior Therapy With an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI). --- T790M ---
Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC The aim of this study is to assess the efficacy and safety of single agent AZD9291 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 received prior EGFR-tyrosine kinase inhibitor (TKI) therapy. --- T790M ---
Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC The aim of this study is to assess the efficacy and safety of single agent AZD9291 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 received prior EGFR-tyrosine kinase inhibitor (TKI) therapy. --- T790M --- --- T790M ---
PFS will be summarized using Kaplan-Meier estimates of the median time to progression or death and quartiles with their 95% confidence intervals.. Inclusion Criteria: 1. Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures 2. Adults (according to each country regulations for age of majority) 3. Locally advanced (stage IIIB) or metastatic (stage IV) EGFRm NSCLC, not amenable to curative surgery or radiotherapy, with confirmation of the presence of the T790M mutation 4. Prior therapy with an EGFR-TKI. --- T790M ---
Any of the following cardiac criteria: 1. Mean resting corrected QT interval (QTcF) > 470 ms using Fredericia's formula : 2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events 7. Any unresolved toxicity from prior therapy CTCAE > grade 3 at the time of starting treatment 8. History of hypersensitivity to excipients of AZD9291 or to drugs with a similar chemical structure or class to AZD9291 Inclusion Criteria: 1. Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures 2. Adults (according to each country regulations for age of majority) 3. Locally advanced (stage IIIB) or metastatic (stage IV) EGFRm NSCLC, not amenable to curative surgery or radiotherapy, with confirmation of the presence of the T790M mutation 4. Prior therapy with an EGFR-TKI. --- T790M ---
Any of the following cardiac criteria: 1. Mean resting corrected QT interval (QTcF) > 470 ms using Fredericia's formula : 2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events 7. Any unresolved toxicity from prior therapy CTCAE > grade 3 at the time of starting treatment 8. History of hypersensitivity to excipients of AZD9291 or to drugs with a similar chemical structure or class to AZD9291 Lung Cancer Lung Neoplasms Objective: The primary objective of this study is to assess the efficacy and safety of single agent AZD9291 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 received prior EGFR-tyrosine kinase inhibitor (TKI) therapy. --- T790M ---
Target patient population: Adult patients (fulfilling the definition of "age of majority" per local regulations) with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC with confirmed T790M mutation, who have received prior EGFR-TKI therapy. --- T790M ---