An Open-Label, Non-randomized, Prospective Biomarker Study to Assess Analytic Concordance Between Non-invasive Testing and Tissue Testing for EGFR T790M Mutation Detection in Patients with Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
18 Years - 130 Years
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Verified 01 Nov 2019 by AstraZeneca
No locations available
|Other: T790M positive|
Patients determined to be T790M positive on cobas tissue and/or cobas plasma testing during Part 1 may be followed for clinical outcomes in Part 2, and will be treated in accordance with standard of care, which may include osimertinib.
Patients who are T790M positive via cobas plasma and/or cobas tissue testing during Part 1 will be treated per standard of care during Part 2, which may include osimertinib.
Other Name: Standard of Care
|No Intervention: T790M negative|
Patients determined to be T790M negative during Part 1 will not be followed for clinical outcomes in Part 2.