TAURAS - T790 AURA ScreenFailure SOC Registry Study

NCT ID: NCT02405247

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-07-31

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).

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 (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

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; T790M; EGFR; TKI; Resistance; Non Small Cell Lung Cancer; AZD9291

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Patient Reported Outcome (PRO)

Intervention Type: OTHER

Exposure to Quality of Life Questionnaires (EORTC QLQ-LC13, EORTC QLQ-C30 and EQ-5D-5L) every 3 months during standard of care visits.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated/allowed by local regulations

2. Aged at least 18 years. Patients from Japan aged at least 20 years

3. Patients who have been considered ineligible for entry into the AZD9291 AURA3 registration trial as a result of their tumour not harbouring the T790M mutation, according to the cobas EGFR test of a biopsy taken following the latest line of therapy, at a central testing lab participating in the D5160C00003 (AURA3) study.

4. Patients who have undertaken or plan to undertake 2nd-line therapy after screen failure for the AURA3 study.

Exclusion Criteria

1. Treatment with any of the following:

• Prior treatment with more than one line of systemic treatment for advanced disease prior to failing screening assessments for AURA3.
• Major surgery (excluding placement of vascular access) within 4 weeks prior to failing screening assessments for AURA3.
• Palliative radiotherapy with a limited field of radiation within 1 week prior to enrolment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks prior to failing screening assessments for AURA3..

2. Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to failing screening assessments for AURA3..

3. Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the study site).

4. Judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

5. Patients who are known to be entering an interventional clinical study (blinded, randomized or open label clinical study) at the time of the enrolment into this study. However, inclusion in this study does not preclude participation in any other clinical study after enrolment. Patients who participate in clinical studies after enrolment into this study will be followed up to the extent possible as permitted by the sponsor of that clinical study.

6. Patients with an invalid or unsuccessful T790M mutation test result during screening for AURA3.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Oceanside, California, United States

Research Site

Santa Rosa, California, United States

Research Site

Seongnam, Gyeonggido, South Korea

Research Site

JinJoo, Gyeongsangnam-do, South Korea

Research Site

Ulsan, Ulsan Gwangyeogsi, South Korea

Countries

Australia; China; Germany; Hong Kong; Italy; Japan; Russia; Spain; Sweden; Taiwan; United Kingdom; United States; South Korea

Other Identifiers

D5160R00003

Identifier Type: -

Identifier Source: org_study_id