CAAA601A62301: A phase III study with [177Lu]Lu-DOTA-TATE in G1/G2 advanced GEP-NET (NETTER-3)
Research type
Research Study
Full title
A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE in patients newly diagnosed with Grade 1 and Grade 2 (Ki-67 <10%) advanced GEP-NET with high disease burden (NETTER-3)
IRAS ID
1011399
Contact name
Maria Topizopoulou
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to learn more about the effects of AAA601 (also called [177Lu]Lu-DOTA-TATE) given with octreotide compared to octreotide alone in people with advanced gastroenteropancreatic neuroendocrine tumours (GEP-NETs). GEP-NETs are a rare type of tumour that develop in parts of the digestive system, such as the small intestine, rectum, colon, pancreas, stomach, and appendix. Advanced means the tumour that has spread to other parts of the body. Common symptoms of GEP-NETs are pain, fatigue, weight loss, loss of appetite, diarrhoea, flushing, sweating, shortness of breath, heart palpitations, low blood pressure, skin rashes and yellowing of the skin or whites of the eyes. AAA601 is an approved treatment for some types of GEP-NETs (advanced, progressive disease), but it is not approved for the group of patients who will take part in this study. Inside the body, it attaches to receptors on the outside of tumour cells, goes inside the cells, and then delivers radiation (which may damage DNA and kill the cells).
Octreotide is a drug that works by targeting specific receptors on the tumour cells, that control the release of certain hormones and other chemicals. By targeting these receptors, octreotide may help to slow tumour growth.
The main questions this trial aims to answer are:
• How long does it take for a participants cancer to worsen or for death to occur after treatment with a combination of AAA601 and octreotide compared with octreotide alone?
Worsening of cancer will be assessed based on the imaging test results for changes in tumour size.
• What medical problems, also known as adverse events and serious adverse events, are reported during this trial?
An adverse event is any sign or symptom experienced during a trial and may or may not be caused by
study treatment. An adverse event is considered serious when it is life-threatening, causes lasting problems, the participant needs
hospital care, or results in death.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0110
Date of REC Opinion
11 Jul 2025
REC opinion
Further Information Favourable Opinion