NCT03392246

A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	may stop (or "inhibit") the growth of a cancer with a mutation in the EGFR gene
DRUG	Selumetinib	may enhance the effect of osimertinib to stop (or "inhibit") the growth of a cancer with a mutation in the EGFR gene

Timeline

• Start date: 2018-01-31
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2018-01-05
• Last updated: 2026-01-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study