Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

This study is looking for adults, aged 18 to 130, with advanced non-small cell lung cancer that cannot be cured by surgery or radiation. Your cancer cells must not have specific genetic changes called EGFR mutations or ALK fusions. You should be generally well and able to perform most daily activities without significant difficulty, reflected by a good 'performance status'. You also shouldn't have received any previous treatment for your advanced lung cancer, and your organs (like your kidneys and bone marrow) need to be working properly. You'll also need to have at least one part of your cancer that can be accurately measured on scans.

To continue into the maintenance part of the study, your cancer must have either shrunk, stayed the same, or partly responded to the initial chemotherapy and Durvalumab. You'll also need good kidney function and be able to swallow tablets whole. Researchers will need a sample of your tumour tissue, either a new one or an existing one from the last three years, to check for certain markers.

However, you cannot take part if you have a specific type of lung cancer called mixed small-cell lung cancer or sarcomatoid variant NSCLC. You also cannot have previously received certain types of cancer drugs, including PARP inhibitors, or any chemotherapy specifically for advanced disease.

If you join the study, you'll first receive a combination of Durvalumab and chemotherapy (chosen by your doctor) over four cycles. During this time, you will have regular visits to the hospital for treatment and check-ups, including blood tests and scans, to see how you're responding. If your cancer hasn't progressed, you'll then be randomly assigned to receive either Durvalumab on its own or Durvalumab plus Olaparib. You'll take these medications until your cancer starts to grow again, you experience side effects that are too much to handle, or you decide to stop participating.

Throughout the study, you will have regular scans to monitor your cancer and frequent visits for blood tests and health checks. After you stop treatment, doctors will continue to follow your health and survival for the remainder of the study. The total duration of your active treatment participation will vary from person to person, depending on how your cancer responds and how well you tolerate the treatment. The overall study will follow patients for their survival until it concludes.