NCT03535363

Who might be able to join this trial:

• You have been diagnosed with a specific type of lung cancer (non-small cell lung cancer) that has a particular genetic change called an EGFR mutation, and it has spread to the brain (new brain metastases).
• You are able to take care of yourself and can walk or be up and about for at least half of your waking hours (confirm with trial site if unsure how this applies to you).
• You have between 1 and 10 tumors in the brain, and none of them are larger than 3 cm (about 1.2 inches) at their widest point.
• Your blood counts are at acceptable levels — including red blood cells, white blood cells, and platelets (a blood test will confirm this).
• Your liver function test results are within an acceptable range (a blood test will confirm this).
• Your kidney function is within an acceptable range (a blood test will confirm this).
• If you are a woman who could become pregnant, you must have a negative pregnancy test within one week before starting treatment.
• If you are sexually active and could father or become pregnant, you must use two reliable forms of contraception during the study and for 120 days after the last dose of the study drug.

Who may not be able to join:

• Your cancer has spread to the lining around the brain or spinal cord (confirmed by MRI scan or spinal fluid test).
• There is significant bleeding inside or around a brain tumor.
• Any brain tumor is located within 5 mm (about 0.2 inches) of the nerves connected to your eyes (optic chiasm or optic nerve).
• You have tumors in the brainstem (the lower part of the brain that controls basic body functions).
• You have a digestive condition where ongoing diarrhea is a major symptom.
• You have a serious or poorly controlled heart condition that significantly limits your daily activities (confirm with trial site).
• You have an existing lung condition involving scarring or inflammation of lung tissue (interstitial lung disease or pneumonitis).
• You are unable to have a brain MRI scan (for example, due to a pacemaker or severe claustrophobia).
• You have HIV, Hepatitis B, or Hepatitis C.
• You have side effects from previous treatments that have not fully resolved at the time of joining the trial.
• You have other medical conditions that could put you at risk during the trial (confirm with trial site).
• You are currently taking part in another clinical trial involving an experimental cancer treatment.
• Your heart's electrical activity shows a specific abnormality on an ECG (a QTc interval of 470ms or more, measured across 3 ECGs) (confirm with trial site).
• Your heart's pumping function is below a certain level (left ventricular ejection fraction of 50% or less, measured by a heart scan).
• You are currently taking certain medications that strongly affect how the study drug is processed by the body — specifically strong CYP3A inhibitors, strong CYP3A4 inducers, or potent CYP2C8 inhibitors (confirm with trial site which medications these include).
• You have had a severe allergic reaction to the study drug (osimertinib) or any of its ingredients.
• You have a corneal ulcer (an open sore on the surface of your eye).
• You are currently pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.