TerminatedNot applicableNCT02405247
Official study title

TAURAS - T790 AURA ScreenFailure SOC Registry Study

Study 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).

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedPatient Reported Outcome (PRO)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 31, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
AstraZeneca
Interventions being studied
Other: Patient Reported Outcome (PRO)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteOceanside, California
  • Research SiteSanta Rosa, California
  • Research SiteSeongnam, Gyeonggido
  • Research SiteJinJoo, Gyeongsangnam-do
  • Research SiteUlsan, Ulsan Gwangyeogsi

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2015. Always confirm current availability with the study team.

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