TAURAS - T790 AURA ScreenFailure SOC Registry Study (TAURAS)
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|ClinicalTrials.gov Identifier: NCT02405247|
Recruitment Status : Terminated (Team's request.)
First Posted : April 1, 2015
Last Update Posted : July 31, 2015
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).
|Condition or disease||Intervention/treatment|
|Non Small Cell Lung Cancer||Other: Patient Reported Outcome (PRO)|
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 Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||TAURAS - T790 AURA ScreenFailure SOC Registry Study|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
NSCLC without T790M mutation
NSCLC patients who have failed first line TKI treatment (defined radiological documentation of disease progression during treatment for advanced or metastatic NSCLC with an approved EGFR-TKI e.g. gefitinib, afatinib or erlotinib) and are screened for the AURA3 study and determined to be lacking the T790M mutation as determined using the AURA3 designated central laboratory using the cobas® EGFR Mutation Test (Roche Molecular Systems).
Other: Patient Reported Outcome (PRO)
Exposure to Quality of Life Questionnaires (EORTC QLQ-LC13, EORTC QLQ-C30 and EQ-5D-5L) every 3 months during standard of care visits.
- Progression Free Survival [ Time Frame: 24 months from last subject in ]This will be assessed as the time from start of 2nd line therapy until the date of disease progression or death by any cause.
- Response to Therapy as assessed by the physician [ Time Frame: 24 months from last subject in ]This will be assessed as the time from start of 2nd line therapy until the date of disease progression or death (by any cause in the absence of progression). To assess efficacy of 2nd line treatment and beyond.
- Time on treatment by line of therapy and between therapies [ Time Frame: 24 months from last subject in ]This will be assessed as the time from start date of line of therapy to end date of line of therapy or death date. To describe treatment patterns for 2nd line and beyond.
- Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visit [ Time Frame: 24 months from last subject in ]This will be assessed as the number and Time from the dates of admission and exit of attendance. To describe Healthcare resource utilization for 2nd line treatment and beyond.
- Time to symptom deterioration [ Time Frame: 24 months from last subject in ]For each of the symptoms in EORTC QLQ-LC13 and EORTC QLQ-C30, Time from inclusion until the date of first clinically meaningful symptom deterioration or death by any cause in the absence of a clinically meaningful symptom deterioration. To assess the impact of 2nd and subsequent lines of therapy on patients' disease-related symptoms and health related quality of life.
- Symptom Improvement Rate [ Time Frame: 24 months from last subject in ]This will be assessed as the number of patients with two consecutive assessments, which showed a clinically meaningful improvement in that symptom from baseline. To assess the impact of 2nd and subsequent lines of therapies on patients' disease-related symptoms and health related quality of life.
- Overall Survival [ Time Frame: 24 months from last subject in ]This will be assessed as the time from the start date of 2nd line chemotherapy until death due to any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405247
|United States, California|
|Oceanside, California, United States|
|Santa Rosa, California, United States|
|Korea, Republic of|
|Seongnam, Gyeonggido, Korea, Republic of|
|JinJoo, Gyeongsangnamdo, Korea, Republic of|
|Ulsan, Ulsan Gwangyeogsi, Korea, Republic of|