Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
This research, called NETTER-2, investigated a new treatment option, Lutathera, for people with advanced neuroendocrine tumours (NETs) in the gut or pancreas (GEP-NETs). The study aimed to find out if Lutathera, given alongside a standard long-acting octreotide injection, could keep the cancer from growing for longer. This was compared to just giving a higher dose of the long-acting octreotide alone. The study focused on patients whose tumours were growing at a faster rate (Grade 2 and 3) and who hadn't received Lutathera before. The goal was to see if this new combination could offer a better first treatment for these patients.
At a glance
Results
Results from this study
Posted October 2024Results have been published for this study.
What is this study about?
This study, called NETTER-2, was designed to investigate a new treatment for certain types of cancer called gastro-entero-pancreatic neuroendocrine tumours, or GEP-NETs. These are rare cancers that can start in the gut or pancreas. The study aimed to see if a medicine called Lutathera, when given together with a standard drug called long-acting octreotide, could help patients live longer without their cancer getting worse, compared to using a higher dose of long-acting octreotide on its own. This was important because it could offer a new and potentially better first treatment option for people with GEP-NETs that have spread or are advanced.
The researchers were particularly interested in patients whose GEP-NETs were growing more quickly, classified as Grade 2 or Grade 3. They wanted to understand if this new combination treatment would be more effective in stopping the cancer's progression for these patients. The study also looked at how safe the new treatment was for patients.
By comparing Lutathera plus long-acting octreotide to high-dose long-acting octreotide, the study aimed to provide clear information to doctors and patients about the best ways to treat these types of advanced neuroendocrine tumours. The ultimate goal was to improve outcomes for patients facing this challenging disease.
Key takeaways
- This study investigated a new treatment for advanced gut or pancreas neuroendocrine tumours.
- It compared Lutathera plus long-acting octreotide against a higher dose of octreotide alone.
- The main goal was to see if the new combination could keep cancer from growing for longer.
- It focused on patients with faster-growing tumours (Grade 2 and 3).
- Participation involved regular hospital visits, treatments, and monitoring.
- You can withdraw from the study at any time without affecting your future care.
Who may be eligible?
To join this study, people needed to have a specific type of advanced gut or pancreas neuroendocrine tumour (GEP-NET) that was confirmed by a doctor within 6 months. Your tumour had to be growing at a certain speed (Grade 2 or Grade 3) and be visible on special scans because it had specific markers that Lutathera targets.
You also needed to be at least 15 years old and weigh more than 40 kg. Your general health and ability to carry out daily activities were assessed, requiring a good score on a standard health measure. Important blood tests, checking your kidney and liver function, and blood cell counts, had to be within a healthy range.
Certain conditions would mean you couldn't join. For example, if you were pregnant or breastfeeding, or if your kidneys, liver, or blood counts were significantly outside the healthy limits. Women who could become pregnant needed to use effective contraception throughout the study and for 7 months afterwards.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have an advanced neuroendocrine tumour in my gut or pancreas?
- Has my tumour been diagnosed within the last six months?
- Are my tumours showing particular markers on scans that Lutathera can target?
- Am I at least 15 years old and weigh more than 40 kg?
- Are my blood tests (kidney, liver, blood counts) generally healthy?
- Am I not pregnant or breastfeeding, and using effective contraception if needed?
What does participation involve?
Taking part in this study involved several stages. First, there was a screening phase to check if you were suitable. If you were, you would then enter the treatment phase. This involved receiving either Lutathera with standard long-acting octreotide, or a higher dose of long-acting octreotide alone.
If you were in the group receiving only high-dose octreotide and your cancer started to grow, you might have the option to switch to the Lutathera treatment later. If you were in the Lutathera group, you might also have the option to receive the Lutathera treatment again if the doctors thought it would help. Throughout the study, you would have regular hospital visits for medication, check-ups, and scans to monitor your health and how your tumour was responding. After your main treatment ended, there would be a follow-up phase to keep an eye on your health and any long-term effects. The total duration of participation would vary depending on your treatment group and how your body responded to the treatments.
Potential risks and benefits
Locations (40)
- Yale Cancer CenterVerified postcodeNew Haven, United States
- USF - H. Lee Moffitt Cancer Center and Research InstituteVerified postcodeTampa, United States
- University of Iowa Hospitals and Clinics - OncologyVerified postcodeIowa City, United States
- University of Kentucky UK Markey Cancer CenterVerified postcodeLexington, United States
- Mayo Clinic - OncologyVerified postcodeRochester, United States
- MD Anderson Cancer CenterVerified postcodeHouston, United States
- London Health Sciences Centre, University of Western Ontario - OncologyVerified postcodeLondon, Canada
- Centre Hospitalier Universitaire de QuebecVerified postcodeQuébec, Canada
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada
- BC Cancer AgencyVerified postcodeVancouver, Canada
- CHU Paris Nord-Val de SeineVerified postcodeClichy, France
- Hospices Civils de Lyon (HCL) - Hopital Edouard HerriotVerified postcodeLyon, France
Common questions
What are GEP-NETs?
GEP-NETs are rare cancers that start in the gut or pancreas (gastro-entero-pancreatic neuroendocrine tumours).
What is Lutathera?
Lutathera is a special type of treatment that targets cancer cells with specific markers to deliver radiation directly to them.
What is octreotide long-acting?
Octreotide is a medicine commonly used for neuroendocrine tumours, and the long-acting version is an injection given less frequently.
What does 'progression free survival' mean?
It means the length of time a person lives with their cancer without it getting worse or spreading further.
Can I leave the study if I want to?
Yes, you can leave the study at any time, for any reason, without affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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