The phase III clinical trial EA5182 is exploring a new treatment option for patients with EGFR-positive non-small cell lung cancer (NSCLC) that has spread outside the lungs (advanced, metastatic). Researchers are studying if adding a drug called bevacizumab to a drug called osimertinib will better control cancer for a longer period of time than osimertinib alone. Most patients with lung cancer have the NSCLC type.
EGFR gene mutations in lung cancer cells drive cancer growth. They are present in the tumors of roughly one in every five people with NSCLC. As a result, tumor testing is recommended. The most commonly used first treatment for patients with EGFR-positive NSCLC is osimertinib, a drug that slows or stops the growth of cancer cells by inhibiting the EGFR gene mutation. Osimertinib is effective, but it usually only works for 1-1 ½ years before cancer starts to grow again.
“Despite leading to improvements in survival compared to older EGFR inhibitors, osimertinib is only effective for a limited period of time,” said lead researcher Helena Yu, MD. “Once cancer starts to grow again, limited non-chemotherapy treatment options exist. As a result, combination approaches to initial treatment are needed to improve outcomes for these patients.”
Patients are eligible for this study if they have newly-diagnosed advanced NSCLC, such as newly diagnosed stage IV disease or certain types of stage IIIB disease. They may also be eligible if they have NSCLC that has come back after an earlier stage I-III diagnosis. Patients must also have the EGFR gene mutation, confirmed by tumor testing. Patients with squamous NSCLC are not eligible.
Bevacizumab is a drug that helps stop or slow the growth of tumors by stopping the formation of blood vessels that bring oxygen and nutrients to them. Bevacizumab is already approved by the Food and Drug Administration (FDA) to give with chemotherapy to treat patients with advanced lung cancer. Osimertinib is approved by the FDA for use by itself to treat lung cancer. The EA5182 trial will evaluate the combination in a randomized phase III trial of 300 patients.
The EA5182 study has two groups. Patients will be randomly assigned by a computer to receive either the usual treatment, osimertinib alone, or the usual treatment plus the study drug, bevacizumab. Osimertinib is a pill to be taken by mouth every day of each treatment cycle. Bevacizumab is given intravenously (IV) on the first day of each cycle (once every three weeks).
Patients will continue on the treatment until it stops working or they have unacceptable side effects. Doctors will follow patients for ten years to watch for side effects and monitor overall health.
This study is led by Helena Yu, MD of Memorial Sloan Kettering Cancer Center.
Learn more about the EA5182 study at ecog-acrin.org.