Non Small Cell Lung CancerTAURASNCT02405247
TAURAS - T790 AURA ScreenFailure SOC Registry Study
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 5 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Patient Reported Outcome (PRO)
- How many people
- 400 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2015to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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 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.
- Patients with an invalid or unsuccessful T790M mutation test result during screening for AURA3.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
South Korea3 sites
Research Site
JinJoo, Gyeongsangnam-do
Research Site
Seongnam, Gyeonggido
Research Site
Ulsan, Ulsan Gwangyeogsi
United States2 sites
Research Site
Oceanside, California
Research Site
Santa Rosa, California
About this study
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).
Read the 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
- Being tested
- Patient Reported Outcome (PRO)
- Keywords
- NSCLC, T790M, EGFR, TKI, Resistance, Non Small Cell Lung Cancer, AZD9291
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Patient Reported Outcome (PRO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months from last subject in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Team's request.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405247
- Sponsor's protocol ID
- D5160R00003
- Acronym
- TAURAS
- Status last verified
- Jul 2015
- First submitted
- 16 Mar 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAURAS - T790 AURA ScreenFailure SOC Registry Study
- ClinicalTrials.gov ID
- NCT02405247
- Acronym / sponsor ID
- TAURAS / D5160R00003
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, T790M, EGFR, TKI, Resistance, Non Small Cell Lung Cancer, AZD9291
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Team's request.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC without T790M mutation | – | Other: Patient Reported Outcome (PRO)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Treatment with any of the following:
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | NSCLC without T790M mutation |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Team's request.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Team's request.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 24 months from last subject in). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.