A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

To be considered for this study, you would generally need to be at least 18 years old and have been diagnosed with a certain type of non-small cell lung cancer that has spread locally or to other parts of your body, and which cannot be treated with surgery or radiotherapy aiming for a cure. It's important that your cancer has the specific EGFR genetic change that this study is focusing on, and that you haven't been treated for this advanced lung cancer before.

Your general health needs to be good enough to participate, and a healthcare professional will check this. You should be able to carry out your daily activities with little difficulty.

There are also certain conditions that would prevent you from joining. For example, if you have certain types of brain tumours that are not stable, or a history of specific lung conditions like interstitial lung disease. The study team will review your full medical history to ensure it's safe for you to take part.

If you join this study, it will involve several stages: a 'screening' period to check if you're suitable, a 'treatment' period where you receive the study medication, and a 'follow-up' period. In the main part of the study, there's a 50/50 chance, decided randomly by a computer, that you will either receive osimertinib on its own or osimertinib with chemotherapy. You will not be able to choose which treatment group you are in.

While you are receiving the study medication, you can expect to visit the hospital about 15 times in the first year. After that, you'll have around 4 visits per year. Each visit might last between 2 and 6 hours, depending on the medical checks needed. You will also need to use appropriate contraception during the study and for a period afterwards if you are able to become pregnant or get someone pregnant.