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ClinicalTrials.gov record
Completed No phase listed Observational

Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients

ClinicalTrials.gov ID: NCT03137264

Public ClinicalTrials.gov record NCT03137264. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 1, 2026, 8:05 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study is being done to determine if non-invasive testing (urine and plasma 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 (via cobas test), as well as 2 plasma samples (via cobas and Guardant360 tests) and 1 urine sample (via Trovera test), tested for EGFR T790M mutation status. If the results of the cobas tissue and/or plasma test 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).

Study identification

NCT ID
NCT03137264
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
AstraZeneca
Industry
Enrollment
44 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 130 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 24, 2017 (Actual)
Primary completion
Nov 10, 2018 (Actual)
Completion
Nov 10, 2018 (Actual)
Last update posted
Nov 7, 2019

2017 – 2018

United States locations

U.S. sites
20
U.S. states
13
U.S. cities
19
Facility City State ZIP Site status
Research Site Anaheim California 92801 —
Research Site Los Angeles California 90017 —
Research Site Santa Rosa California 95403 —
Research Site St. Helena California 94574 —
Research Site Deerfield Beach Florida 33442 —
Research Site Fort Lauderdale Florida 33308 —
Research Site Honolulu Hawaii 96819 —
Research Site Boise Idaho 83706 —
Research Site Chicago Illinois 60612 —
Research Site Harvey Illinois 60426 —
Research Site Annapolis Maryland 21401 —
Research Site Southfield Michigan 48075 —
Research Site Brick New Jersey 08724 —
Research Site Farmington New Mexico 87401 —
Research Site White Plains New York 10601 —
Research Site Asheville North Carolina 28801 —
Research Site Hendersonville North Carolina 28792 —
Research Site Kettering Ohio 45409 —
Research Site Seattle Washington 98101 —
Research Site Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03137264, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 7, 2019 · Synced Nov 1, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03137264 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →