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NCT03137264 · ClinicalTrials.gov registry record
Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients
A clinical trial, sponsored by AstraZeneca.
- Completed
- Registry status
- 44
- Enrollment target
NCT03137264: Completed study, sponsored by AstraZeneca.
NCT03137264 is a clinical trial that has completed, run by AstraZeneca. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03137264 has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The Overall Percent Agreement will be estimated as analytic concordance between Guardant360 plasma and Trovera urine testing versus cobas tissue testing in identifying T790M status (positive or negative). The Positive Percent Agreement will be estimated as the percentage of cobas tissue positive patients who are also Guardant360 plasma and/or Trovera urine positive. The Negative Percent Agreement will be estimated as the percentage of cobas tissue negative patients who are also Guardant360 plasm
Interventions
- DRUG Other
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2018-11-10 |
What the finished NCT03137264 record still lists
NCT03137264 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Other is the first listed.
NCT03137264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03137264 about?
NCT03137264 is a clinical study titled "Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients". 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 an...
What is the current status of trial NCT03137264?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2017-10-24. Estimated completion is 2018-11-10.
What interventions are being tested in trial NCT03137264?
The interventions under investigation include: Other (DRUG).
Who is sponsoring clinical trial NCT03137264?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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