TAURAS - T790 AURA ScreenFailure SOC Registry Study — TAURAS  

Non Small Cell Lung Cancer Clinical Trial

Official title: TAURAS - T790 AURA ScreenFailure SOC Registry Study

Status Terminated

Clinical Trial 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).

Clinical Trial 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 (e.g., 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

• NCT number: NCT02405247
• Study type: Observational
• Source: AstraZeneca
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Completion date: July 2015