A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT03434418
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- osimertinib — DRUG80 mg oral administration daily
Study Details
This is a research study to find out if a drug called, osimertinib, is safe and effective in treating advanced Non-Small Cell Lung Cancer (NSCLC) by targeting the treatment of epidermal growth factor receptor (EGFR) mutation exon 18 G719X, exon 20 S7681, or exon 21 L861Q. Patients on the study will not have had previous tyrosine kinase inhibitor (TKI) treatment.
Key Dates
- Start date
- Jun 30, 2018
- Status verified
- Oct 2023
- Primary completion
- Oct 12, 2022
- Completion
- Oct 12, 2022
Study Design
- Enrollment
- 17 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: osimertinib
Primary Outcome Measure
Objective Response Rate as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) [ Time Frame: Up to 4 years ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | - |
| The Ohio State University Medical Center | Columbus | Ohio | 43202 | - |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | - |
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