A Phase III Study of Osimertinib with or without Bevacizumab as Initial Treatment for Patients with EGFR-Mutant Non-Small Cell Lung Cancer

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Full Title

Randomized Phase III Study of Combination AZD9291 (osimertinib) and Bevacizumab versus AZD9291 (osimertinib) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) (EA5182) (CIRB)

Purpose

In this study, researchers are comparing the effectiveness bevacizumab plus osimertinib versus osimertinib alone as initial treatment for patients with stage IIIB-IV non-small cell lung cancer that contains a mutation in a gene called EGFR.

The EGFR protein is involved in cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells, causing them to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking the EGFR protein, which is needed for cell growth in this type of cancer. Bevacizumab may interfere with the ability of tumor cells to grow and spread.

Giving osimertinib with bevacizumab may control cancer longer and help patients live longer compared with osimertinib alone. Patients in this study will be randomly assigned to receive osimertinib alone or with bevacizumab. Osimertinib is taken orally (by mouth) and bevacizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIIB-IV non-small cell lung cancer with an EGFR mutation.
  • Patients may not have received prior medical treatment for their cancer. Previous radiation therapy is allowed as long as it was completed at least 2 weeks before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-608-3912.

Protocol

21-045

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators