Phase 2 Study of Osimertinib and Selumetinib for Advanced EGFR Mutant Lung Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT03392246
This clinical trial is exploring a new combination of two targeted therapies, Osimertinib and Selumetinib, to treat advanced Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The study aims to determine if this combination is safe and effective in treating this type of lung cancer.
Patient Parameters
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Program Overview
This study is testing a combination of two drugs, Osimertinib and Selumetinib, to see if they can effectively treat Non-Small Cell Lung Cancer (NSCLC) with a specific mutation in the EGFR gene. These drugs are designed to target and block the effects of the mutation that causes cancer cells to grow. The study will look at how well the cancer responds to this treatment and any side effects that may occur.
Description
This is a Phase II clinical trial, which means it is focused on testing the safety and effectiveness of a new drug combination. The drugs being studied, Osimertinib and Selumetinib, are not yet approved by the FDA for use together, but they have shown promise in other studies. The EGFR gene mutation can cause lung cancer by making cells divide uncontrollably. Osimertinib is already used to treat some patients with this mutation, but this study is testing if adding Selumetinib can improve results. The main goal is to see if this combination can help shrink tumors and to monitor any side effects.
Eligibility Criteria
Inclusion Criteria
- Must have stage IV Non-Small Cell Lung Cancer (NSCLC) with a specific EGFR mutation (L858R or exon 19 deletion).
- Must have at least one tumor that can be measured by scans or exams.
- Must not have received any previous EGFR-targeted therapy or chemotherapy for advanced cancer.
- Must be 18 years or older.
- Must be in good overall health with a performance status of 0 or 1.
- Must have normal blood and organ function based on specific medical tests.
- Must provide a tumor sample for genetic testing.
- Must be at least two weeks past any major surgery or radiation treatment.
- Must agree to use effective birth control during and after the study.
- Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Cannot have had previous treatment with EGFR-targeted therapies or other similar drugs.
- Cannot have uncontrolled brain or spinal cord cancer spread.
- Cannot have allergies to the study drugs or similar compounds.
- Cannot be taking certain medications that interfere with the study drugs.
- Cannot have unresolved side effects from previous treatments.
- Cannot have had other cancers in the past three years, except for certain skin or cervical cancers.
- Cannot have severe heart conditions or other serious medical issues.
- Cannot have active infections like hepatitis or HIV.
- Cannot be pregnant or breastfeeding, and must use effective birth control if of childbearing potential.
- Cannot have certain eye conditions or be at risk for heart rhythm problems.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital | 02214 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Duke University | 27710 | Durham | North Carolina |
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