Osimertinib + Selumetinib for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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)* Selumetinib
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that are potent inhibitors or inducers of CYP3A4, as well as high doses of supplemental vitamin E. If you are on these medications, you will need to follow specific washout times before participating.
Is the combination of Osimertinib and Selumetinib safe for humans?
How is the drug combination of Osimertinib and Selumetinib unique for lung cancer treatment?
The combination of Osimertinib and Selumetinib is unique because it targets specific mutations in lung cancer cells, with Osimertinib focusing on the EGFR mutation and Selumetinib inhibiting MEK1/2, potentially overcoming resistance to other treatments. This approach aims to improve effectiveness by addressing multiple pathways that cancer cells use to grow.12678
What data supports the effectiveness of the drug combination Osimertinib and Selumetinib for lung cancer?
Osimertinib has shown effectiveness in treating non-small cell lung cancer (NSCLC) with specific mutations, improving disease-free survival and being well-tolerated. It targets mutations that often cause resistance to other treatments, making it a promising option for certain lung cancer patients.12679
Who Is on the Research Team?
Pasi Janne
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with stage IV Non-Small Cell Lung Cancer (NSCLC) who have specific EGFR mutations and are new to treatment. They must be in good physical condition, not pregnant or breastfeeding, willing to use contraception, and have no history of severe allergic reactions to similar drugs. Prior cancer treatments should not include EGFR-targeted therapy or chemotherapy for metastatic disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Osimertinib daily and Selumetinib intermittently (4 days on, 3 days off) to assess safety and effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
- Selumetinib
Osimertinib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
National Comprehensive Cancer Network
Collaborator