Clinical trial NCT02405247: TAURAS - T790 AURA ScreenFailure SOC Registry Study
Official title: TAURAS - T790 AURA ScreenFailure SOC Registry Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
T790M
EGFR
TKI
Resistance
Non Small Cell Lung Cancer
AZD9291
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2015-04-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 24 months from last subject in
measure: Response to Therapy as assessed by the physician
timeFrame: 24 months from last subject in
measure: Time on treatment by line of therapy and between therapies
timeFrame: 24 months from last subject in
measure: Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visit
timeFrame: 24 months from last subject in
measure: Time to symptom deterioration
timeFrame: 24 months from last subject in
measure: Symptom Improvement Rate
timeFrame: 24 months from last subject in
measure: Overall Survival
timeFrame: 24 months from last subject in
Secondary outcomes:
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Seongnam
country: Korea, Republic of
facility: Research Site
state: Gyeonggido
city: JinJoo
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnamdo
city: Ulsan
country: Korea, Republic of
facility: Research Site
state: Ulsan Gwangyeogsi
Study officials:
References: