Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

To join this study, you would generally need to be at least 18 years old and have early-stage lung cancer (non-small cell lung cancer) that hasn't spread to outside the lung and lymph nodes. Your doctor would have already decided that you will receive a specific type of radiation therapy called SBRT as your main treatment. You would also need to be generally well enough to take part, meaning you can carry out most of your daily activities without much trouble, and your body's organs are working properly. Your weight must be over 30kg, and doctors would expect you to live at least 12 more weeks.

There are also some specific things that might mean you can't join. For example, if you have a different type of lung cancer mixed in, or if you've had an organ transplant. You might also be excluded if you have certain other serious health conditions or have received specific immune-boosting treatments before. Your cancer must be confirmed to be early stage and not have spread to other parts of the body.

For the group of patients receiving osimertinib, a key requirement is that your cancer cells must have a specific genetic change called an EGFR mutation. If your cancer does have this mutation, you might be suitable for that part of the study but would not be suitable for the other part testing durvalumab. Before joining, if you are a woman of childbearing age, you would need to use effective contraception, and men would also need to use contraception during the study and avoid fathering children.

If you decide to take part in the study, what happens next depends on which part of the study you join. For the main group, you would be randomly assigned to receive either durvalumab or a placebo, in addition to your standard SBRT radiation therapy. All study treatments involve regular visits for examinations, blood tests, and to receive the medication. You would also have regular scans to monitor your health and how the treatment is working.

For the group receiving osimertinib, you would start this medication after you complete your SBRT. Again, this would involve regular check-ups, blood tests, and scans to monitor you. The total duration of your participation in the study, including examinations and follow-up, will be clearly explained by the study team, but generally involves long-term monitoring to see the effects of the treatment.