Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

This study is looking for people who have been diagnosed with a specific type of advanced neuroendocrine tumour affecting the gut or pancreas (GEP-NETs). The cancer needs to be well-understood by doctors, with a recent diagnosis (within the last six months) and it shouldn't be possible to cure with surgery. Participants must also have specific markers on their cancer, which doctors can check with special scans.

To join, you need to be at least 12 years old. Doctors will consider if your cancer has a 'high disease burden'. This could mean the main tumour or a tumour that has spread is bigger than 4cm, or there are several tumours larger than 2cm. Other signs of high disease burden include changes in certain blood tests, cancer in your bones or the lining of your belly, or if the cancer is causing bothersome symptoms like pain, tiredness, or weight loss.

Before you start, doctors will also check your general health, including your blood counts and how well your kidneys and liver are working. These checks are important to make sure it's safe for you to take part in the study medicines.

If you decide to take part, the study will involve several stages. First, there's a 'screening phase' where doctors will do various tests and scans to make sure you meet all the requirements for the study. This might include blood tests and special scans to look at your tumour.

If you're eligible, you'll then enter the 'treatment phase'. During this time, you'll receive either the new combination treatment or Octreotide LAR on its own. You'll have regular visits to the clinic for your treatments, check-ups, blood tests, and scans. The medical team will keep a close eye on you to see how you're responding to the treatment and to check for any side effects.

After your treatment is complete, there will be a 'follow-up phase'. This means you'll continue to have check-ups for a period of time to monitor your health and long-term effects of the treatment. The total length of time you'll be involved in the study, from your first screening appointment to your last follow-up, will depend on the study plan, but it generally lasts for a number of years.