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Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients
Overall Recruitment Status: Study completed
Official Title
An Open-Label, Non-randomized, Prospective Biomarker Study to Assess Analytic Concordance and Clinical Validity Between Non-invasive Testing and Tissue Testing for EGFR T790M Mutation Detection in Patients With Non-small Cell Lung Cancer
Region Sponsors
Acronym KP IRB No.
Study Type Phase
Clinical Trial n/a
Study Population Description
The study is being done to determine if non-invasive testing (urine and blood testing) is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status. EGFR is a type of protein found on the surface of cells in the body. When this protein is mutated and becomes too active, it can lead to cancer growth. T790M is a mutation that develops in response to treatment of the EGFR mutation. Participating patients will have tumor tissue as well as blood and urine samples, tested for EGFR T790M mutation status. If the results of one of the three tests show that a patient is T790M positive, they will be treated according to standard of care, which may include treatment with osimertinib. Osimertinib is approved for use in the United States for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). The study will look at how well patients who are confirmed T790M mutation positive (by urine and blood testing) respond to treatment compared to patients who are confirmed T790M positive by tissue testing.
Detailed Description
Gender Age Limit
Male & Female 18 years & older
Inclusion Criteria
  • Provision of informed consent prior to any study-specific procedures
  • Females and males >/= 18 years
  • Primary diagnosis of NSCLC with evidence of disease progression during or following treatment with an EGFR tyrosine kinase inhibitor (diagnosis of NSCLC that is confirmed by cytology is acceptable)
  • Willing to undergo tumor biopsy (e.g., excision, core biopsy, or endoscopic biopsy), preferably of a progressing lesion, and provide blood and urine for biomarker testing
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion Criteria
  • Involvement in the planning and/or conduct of the study
  • Prior treatment with osimertinib or another T790M directed therapy
  • Current participation in another clinical study with an investigational product or patients who plan to receive any treatment that is not FDA-approved for EGFR mutation positive NSCLC at any time during the course of this study
  • Use of any chemotherapeutic agent within 1 week of tissue, plasma, and urine sample collection
  • For women - currently pregnant or plan to become pregnant during the course of the study: pre-menopausal women of childbearing potential must have a urine or serum pregnancy test performed during the screening/enrollment period and prior to initiating anti-cancer treatment

Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
KP Clinical Facility
  • Moanalua Medical Center and Clinic
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Jennifer Carney, MD
Contact Information:
- Shelley Clark, RN
-Moanalua Medical Center and Clinic

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