Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)

To join this study, you must be at least 18 years old. The most important thing is that you are currently taking osimertinib in another AstraZeneca study for cancer, and your doctor thinks it's still helping you. You also need to be willing to sign a consent form, which means you understand what the study involves and agree to take part. If you can get osimertinib as a regular treatment where you live, and it costs nothing to you, then you might not be able to join this study.

There are also some reasons why you wouldn't be able to join. For example, if you had very serious side effects (meaning Grade 3 or worse) from osimertinib in your previous study that haven't cleared up, you wouldn't be eligible. You also can't join if the osimertinib stopped working for you in the previous study, or if you had to stop the earlier study permanently because of side effects or your cancer getting worse.

Finally, you can't be part of another medical research study at the same time if it clashes with this one. If you have certain ongoing infections like hepatitis C, HIV, or active and uncontrolled hepatitis B, you also wouldn't be able to join, although there are specific rules for people with controlled hepatitis B.

If you join the ROSY-T study, you will continue to take osimertinib, just as you were in your previous study. This study is designed to be a continuation of your treatment. You will have regular visits with your doctor and the study team, likely involving check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study is "open-label," meaning you and your doctors will know you are taking osimertinib.

You will keep taking osimertinib as long as your doctor thinks it is benefiting you and you are not experiencing severe side effects. There isn't a set total duration for the study; it continues until your doctor decides the treatment is no longer effective, or if you need to stop due to side effects. You will be closely monitored throughout this time.