T790M mutation positive 2nd line STandard of cAre Registry - T-STAR

Study identifier:D5160R00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

T-STAR - T790M mutation positive 2nd line STandard of cAre Registry

Medical condition

Non Small Cell Lung Cancer

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Observational

Age

18 Years - 99 Years

Date

Study Start Date: 01 Jun 2015

Estimated Primary Completion Date: 01 Jun 2018

Estimated Study Completion Date: 01 Jun 2018

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: -

Verification:

Verified 01 Jul 2015 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

- Provision of signed and dated written informed consent prior to any study specific procedure.
- Patients with histologically- or cytologically-documented NSCLC who present with Stage IIIB/ Stage IV disease.
- Evidence of radiological disease progression following 1st line treatment for advanced/metastatic NSCLC with an approved EGFR-targeted TKI monotherapy without any additional concurrent NSCLC treatment. Chemotherapy received in the adjuvant setting is permitted.
- Patients prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) for 2nd line treatment of NSCLC. Treatment must have been selected by physician as part of routine standard of care, prior to confirming eligibility for the study. Patient must be enrolled into the study within two cycles of beginning treatment. Treatment must be given in accordance with local prescribing information.
- Confirmation prior to enrolment into the study that the tumour harbours the following EGFR mutations known to be associated with EGFR-targeted TKI sensitivity: Ex19Del, L858R, L861Q, and G719X.
- Patients must have had confirmation that tumour is T790M mutation positive from a biopsy or cytology sample taken after confirmed disease progression on 1st line treatment with an approved EGFR-targeted TKI.
- WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.

Exclusion Criteria

- Treatment with any of the following:
•Prior treatment with more than one line of treatment for advanced NSCLC.
•Major surgery (excluding placement of vascular access) within 4 weeks prior to enrolment.
•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 enrolment.
- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to enrolment.
- Patients who are known to be entering an alternative interventional clinical study at the time of enrolment into this study will be excluded. 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 to the extent possible as permitted by the sponsor of that clinical study.
- Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the site).
- Judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with procedures, restrictions, and requirements.

No locations available

Arms	Assigned Interventions
NSCLC T790M positive NSCLC patients who have had 1st line treatment with an approved EGFR targeted TKI, who are known to be T790M mutation positive and who have been prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) as a 2nd line treatment as part of their standard care.	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]