Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

Official Title

Open Label, Multicentre, Phase II Study of Patients With Treatment Naïve Metastatic Epidermal Growth Factor Receptor (EGFR) Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases Randomized to Stereotactic Radiosurgery (SRS) and Osimertinib or Osimertinib Alone

Summary:

This open-label, multicentre, randomized phase II study will evaluate the usage of osimertinib alone for brain metastases compared to SRS and osimertinib in patients with newly diagnosed, treatment naiive EGFR positive lung cancer.

Trial Description

Primary Outcome:

• Intracranial progression free survival

• Intracranial overall response rate
• Time to whole brain radiation therapy (WBRT)
• Time to stereotactic radiosurgery (SRS)
• Rate of radionecrosis
• Overall survival
• Time to distant progression
• Quality of life
• Neurocognitive function
• Exposure to osimertinib

View this trial on ClinicalTrials.gov