A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
|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: NCT03392246|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : November 18, 2019
This research study is studying a combination of two targeted therapies as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.
The drugs involved in this study are:
- Osimertinib (Tagrisso)
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Osimertinib Drug: Selumetinib||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.
The EGFR gene produces a protein that helps cells divide. Specific changes or a mutation in the genetic information causes abnormal cell division and can lead to lung cancer. Patients who have NSCLC with an EGFR gene mutation can be treated by drugs called EGFR tyrosine kinase inhibitors (EGFR TKIs). They may stop (or "inhibit") the effect of the mutation in the EGFR gene.
Osimertinib alone has been shown to benefit some patients who have received prior treatment for their EGFR-mutant NSCLC. The FDA (the U.S. Food and Drug Administration) has not approved the combination of Osimertinib and Selumetinib as a treatment for any disease, but it has been investigated in other clinical trials.
The main purpose of the study is to look at information on any potential side effects that this drug combination may cause and collect data about how your cancer responds to the combination of drugs.
Specific TKIs have been approved by the FDA for first-line treatment of NSCLC patients with an EGFR mutation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer|
|Actual Study Start Date :||January 31, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2025|
Experimental: Osimertinib + Selumetinib
may stop (or "inhibit") the growth of a cancer with a mutation in the EGFR gene
may enhance the effect of osimertinib to stop (or "inhibit") the growth of a cancer with a mutation in the EGFR gene
Other Name: AZD6244
- Best Objective Response [ Time Frame: 2 years ]RECIST1.1 measurements of CT scans will be measured during treatment to determine the objective response rate for patients being treated with combination osimertinib and selumetinib. A response rate and a 95% confidence interval will be calculated.
- Progression Free Survival [ Time Frame: 2 years ]Time from registration to documented disease progression or death from any cause, whichever occurs first. The Kaplan-Meier method will be used to determine the progression-free survival of patients enrolled on protocol and treated with combination osimertinib and selumetinib.
- Overall Survival [ Time Frame: 2 years ]Survival follow-up with clinic visits or phone calls will be used to monitor for overall survival, from the time of study randomization to death from any cause. The Kaplan-Meier method will be used to calculate overall survival.
- Tolerability [ Time Frame: 2 years ]Fraction of patients continuing on study therapy at 6 months.
- Toxicity [ Time Frame: 2 years ]Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.
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): NCT03392246
|Contact: Pasi A Janne, MD, PhD||877-338-7425||pasi_janne@DFCI.HARVARD.EDU|
|Contact: DFCI Clinical Trials Hotline||877-338-7425|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02214|
|Contact: Zofia Piotrowska, MD firstname.lastname@example.org|
|Principal Investigator: Zofia Piotrowska, MD|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Daniel Costa, MD, PhD email@example.com|
|Principal Investigator: Daniel Costa, MD, PhD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: DFCI Clinical Trials Hotline 877-338-7425|
|Principal Investigator: Pasi A Janne, MD, PhD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Thomas Stinchcombe, MD|
|Contact: Thomas Stinchcombe, MD Thomas.firstname.lastname@example.org|
|Principal Investigator:||Pasi A Janne, MD, PhD||Dana-Farber Cancer Institute|