TAURAS - T790 AURA ScreenFailure SOC Registry Study

NCT02405247 | Terminated

• 1 other identifier: D5160R00003
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 5

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).

Conditions

Non Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Progression Free Survival

  This will be assessed as the time from start of 2nd line therapy until the date of disease progression or death by any cause.

  24 months from last subject in

• Response to Therapy as assessed by the physician

  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.

  24 months from last subject in

• Time on treatment by line of therapy and between therapies

  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.

  24 months from last subject in

• Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visit

  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.

  24 months from last subject in

• Time to symptom deterioration

  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.

  24 months from last subject in

• Symptom Improvement Rate

  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.

  24 months from last subject in

• Overall Survival

  This will be assessed as the time from the start date of 2nd line chemotherapy until death due to any cause.

  24 months from last subject in

Study Arms (1)

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)

Interventions

Patient Reported Outcome (PRO) 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.

NSCLC without T790M mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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). Only sites that are participating in the AURA3 study, and patients who had the T790M mutation tested for AURA3 screening (and determined not to have the T790M mutation) will be included. The study plans to enroll approximately 400 patients from approximately 136 sites in an estimated 17 countries globally.

You may qualify if:

• 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
• Aged at least 18 years. Patients from Japan aged at least 20 years
• 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.
• Patients who have undertaken or plan to undertake 2nd-line therapy after screen failure for the AURA3 study.

You may not qualify if:

• 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..
• 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..
• Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the study site).
• 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.
• Patients with an invalid or unsuccessful T790M mutation test result during screening for AURA3.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (5)

Research Site

Oceanside, California, United States

Location

Research Site

Santa Rosa, California, United States

Location

Research Site

Seongnam, Gyeonggido, South Korea

Location

Research Site

JinJoo, Gyeongsangnam-do, South Korea

Location

Research Site

Ulsan, Ulsan Gwangyeogsi, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 1, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

KR (3); US (2)