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

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)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-
The Ohio State University Medical CenterColumbusOhio43202-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-

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