A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

To join this study, you would generally need to be at least 18 years old and have a specific type of lung cancer (NSCLC) confirmed by a biopsy. Crucially, your cancer must have a particular genetic change called an EGFR mutation, which your doctors will be able to test for. You must also have had an operation that completely removed your lung tumour, meaning no cancer was left behind after surgery. Your doctors will have classified your cancer as Stage II, IIIA, or IIIB based on what they found during the operation.

It’s also important that you've recovered well from your surgery and any other treatments you might have had, like chemotherapy, before starting the study medicine. Your general health should be good, often described by doctors as a 'performance status' of 0 or 1, meaning you’re able to carry out most daily activities without too much difficulty.

There are also some reasons why you might not be able to join. For example, if you've recently had other major surgery (besides the lung tumour removal), are taking certain strong medicines or herbal supplements, or have a history of other serious cancers (except for easily treated skin cancers). Women who could become pregnant would need to use effective birth control and have a negative pregnancy test, and men would also need to use effective barrier contraception during the study.

If you take part in this study, you would receive the study medicine, osimertinib, as tablets. You would take this medication every day for a total of five years. You'll have regular visits to the hospital for checks to see how you're doing and if the medicine is working. These visits will also involve safety checks, such as blood tests and possibly scans, to make sure you're tolerating the treatment well.

During your time in the study, doctors and nurses will closely monitor your health and any side effects you might experience. After the 5 years of taking the medication, there will still be follow-up appointments to continue monitoring your health and the long-term effects. The total duration of active treatment is 5 years, but follow-up could extend beyond that to understand the longer-term benefits.