Ignite Creation Date:
2024-05-06 @ 3:54 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02405247
Status:
TERMINATED
Last Update Posted:
2015-07-31
First Post:
2015-03-16
Brief Title:
TAURAS - T790 AURA ScreenFailure SOC Registry Study
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
TAURAS - T790 AURA ScreenFailure SOC Registry Study
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Teams request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAURAS
Brief Summary:
The aim of this study is to evaluate clinical outcomes of 2nd line therapy in NSCLC patients without the T790M mutation both independently and when compared indirectly with NSCLC patients with the T790M mutation in the T STAR non interventional study D5160R00001
The patient population in the TAURAS study will consist of patients who fail screening for AURA3 D5160C00003 due to a T790M mutation not detected using the central cobas EGFR Mutation Test Roche Molecular Systems
The patient population in the TAURAS study will consist of patients who fail screening for AURA3 D5160C00003 due to a T790M mutation not detected using the central cobas EGFR Mutation Test Roche Molecular Systems
Detailed Description:
The study design is an observational prospective cohort study The study plans to enroll approximately 400 patients from an estimated 17 countries
Patients will be recruited from the patient pool that is being screened for the AZD9291 AURA3 randomized clinical trial RCT Biopsy tissues and consents have already been obtained from patients to use samples for future research as part of the AURA3 trial screening processes During the RCT screening process the patients sign a full consent to participate in the AURA3 trial and have their tumour tested as part of the main screening
Data are collected notably on medical history co-medications and adverse events Biopsy tissue is collected to assess T790M mutation status All patients will be able to enter the TAURAS study regardless of whether or not they have any remaining tissue Biomarker analyses resulting from the historical tumour samples obtained as part of the AURA3 screening process and in accordance with the consent obtained within the AURA3 trial protocol can be linked to the data collected in TAURAS and used as part of the exploratory objectives of this NIS
The primary objectives of the NIS study in NSCLC patients who have progressed on a previous EGFR-TKI with no intervening chemotherapy and who do not harbour the T790M mutation according to central analysis using the Roche cobas EGFR Mutation Test are
To estimate overall survival
To estimate disease progression as assessed and defined by physician
To estimate partial complete and overall response rates by line of therapy as assessed and defined by physician
To describe treatment patterns for 2nd line and beyond including time on treatment by line of therapy and time to subsequent therapies or death
To describe health resource utilization patterns eg hospitalizations emergency room visits
To capture patient reported symptoms functioning and health-related quality of life HRQoL data using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items EORTC QLQ-C30 and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items EORTC QLQ-LC13
To capture health state utilities using the EQ-5D-5L questionnaire
Patients will be recruited from the patient pool that is being screened for the AZD9291 AURA3 randomized clinical trial RCT Biopsy tissues and consents have already been obtained from patients to use samples for future research as part of the AURA3 trial screening processes During the RCT screening process the patients sign a full consent to participate in the AURA3 trial and have their tumour tested as part of the main screening
Data are collected notably on medical history co-medications and adverse events Biopsy tissue is collected to assess T790M mutation status All patients will be able to enter the TAURAS study regardless of whether or not they have any remaining tissue Biomarker analyses resulting from the historical tumour samples obtained as part of the AURA3 screening process and in accordance with the consent obtained within the AURA3 trial protocol can be linked to the data collected in TAURAS and used as part of the exploratory objectives of this NIS
The primary objectives of the NIS study in NSCLC patients who have progressed on a previous EGFR-TKI with no intervening chemotherapy and who do not harbour the T790M mutation according to central analysis using the Roche cobas EGFR Mutation Test are
To estimate overall survival
To estimate disease progression as assessed and defined by physician
To estimate partial complete and overall response rates by line of therapy as assessed and defined by physician
To describe treatment patterns for 2nd line and beyond including time on treatment by line of therapy and time to subsequent therapies or death
To describe health resource utilization patterns eg hospitalizations emergency room visits
To capture patient reported symptoms functioning and health-related quality of life HRQoL data using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items EORTC QLQ-C30 and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items EORTC QLQ-LC13
To capture health state utilities using the EQ-5D-5L questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None