A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03434418|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : September 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: osimertinib||Phase 2|
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.
Patients who have one of the following EGRF mutations: exon 18 G719X, exon 20 S7681, or exon 21 L861Q) may be eligible to participate in this study. If enrolled into the study, the study team will give the patient a supply of the study drug, osimbertinib (80 mg) to take at home. The patient will be asked to take the study drug by mouth on days 1-28 of each study cycle. As part of this study, the patient will have blood samples other tests, exams and procedures done for study purposes and their standard of care. Patient participation in the study will last for up to 2 years after completion of the last dose of the study drug or until your condition worsens or intolerable adverse events as deemed by the study doctor.
There are possible patient risks to this study that include but are not limited to diarrhea, changes to the lining of the mouth (e.g. ulcers), rash, dry skin, itching, and nail infections.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase II Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations|
|Actual Study Start Date :||June 30, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2024|
80 mg oral administration daily
Other Name: Tagrisso
- Objective response rate as assessed by the investigator using Response Evaluation Criteria In Solid Tumors RECIST 1.1 (brand name) [ Time Frame: Up to 3 years ]RECIST 1.1 will be used to measure confirmed partial or complete responses to the study drug.
- Progression free survival as measured by Response Evaluation Criteria In Solid Tumors RECIST 1.1 (brand name) as assessed by the investigator. [ Time Frame: Up to 5 years ]Progression will be defined as time from starting study therapy to disease progression or death (whichever occurs first)
- AEs as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 3 years ]Evaluation of safety using the National Cancer Institute (NCI) CTCAE version 4.03
- Overall survival as noted by follow-up via composite of telephone or medical record review. [ Time Frame: Up to 5 years ]Overall survival as defined as time from starting study therapy until death from any causes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434418
|Contact: Ann-Marie Petersfirstname.lastname@example.org|
|Contact: Debra Shoemaker||919-687-4768||Debra.email@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Ann Marie Peters 919-681-3510 firstname.lastname@example.org|
|Contact: Debra Shoemaker 919-681-4768 Debra.email@example.com|
|Principal Investigator: Thomas Stinchcombe, MD|
|United States, Ohio|
|The Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43202|
|Contact: April Green 614-685-7037 April.Green2@osumc.edu|
|Contact: Stephanie Hehemann-Smith 613-366-6413 firstname.lastname@example.org|
|Principal Investigator: Greg Otterson, MD|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Daniel Goldstein 412-864-7820 email@example.com|
|Contact: Jennifer Ruth 412-623-8963 firstname.lastname@example.org|
|Principal Investigator: Liza Villaruz, MD|
|Principal Investigator:||Thomas Stinchcombe, MD||Duke University|