177Lu-DOTA-TATE + Octreotide LAR for Neuroendocrine Tumors
(NETTER-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining [177Lu]Lu-DOTA-TATE, a type of targeted radiotherapy, with Octreotide LAR is more effective and safe than using Octreotide LAR alone for treating advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread or cannot be surgically removed. The trial focuses on individuals with a high disease burden, characterized by large or multiple tumors, or symptoms such as pain and fatigue. Those diagnosed with these tumors within the last six months and whose tumors respond to specific scans might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment nearing widespread availability.
Will I have to stop taking my current medications?
The trial requires that participants stop taking certain medications, specifically short-acting octreotide and other somatostatin analogues, at least 24 hours and 4 weeks, respectively, before receiving the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that [177Lu]Lu-DOTA-TATE is generally well-tolerated by patients. One study confirmed its safety, with most patients responding well during treatment. Another study found that combining [177Lu]Lu-DOTA-TATE with octreotide LAR improved patient outcomes without unexpected safety issues. Some side effects, such as nausea or tiredness, may occur, but they are usually manageable. Overall, the treatment has a good safety record, making it a viable option for many patients.12345
Why do researchers think this study treatment might be promising for neuroendocrine tumors?
Researchers are excited about [177Lu]Lu-DOTA-TATE combined with Octreotide LAR because it offers a new approach to treating neuroendocrine tumors. Unlike the standard treatment, which often involves using only somatostatin analogs like Octreotide LAR to control symptoms, [177Lu]Lu-DOTA-TATE delivers targeted radiation directly to tumor cells. This precise delivery method specifically attacks cancer cells while sparing most healthy tissue. By combining the targeted radiation of [177Lu]Lu-DOTA-TATE with the proven symptom control of Octreotide LAR, this treatment has the potential to not only manage symptoms but also reduce tumor size more effectively than traditional therapies.
What evidence suggests that [177Lu]Lu-DOTA-TATE plus Octreotide LAR could be an effective treatment for neuroendocrine tumors?
This trial will compare the effectiveness of [177Lu]Lu-DOTA-TATE combined with octreotide LAR to octreotide LAR alone for treating neuroendocrine tumors. Research has shown that the combination of [177Lu]Lu-DOTA-TATE and octreotide LAR effectively treats neuroendocrine tumors. Studies have found that this treatment significantly increases the time patients live without their disease worsening, known as progression-free survival. Specifically, one study extended progression-free survival by 14 months compared to using octreotide LAR alone. Another study demonstrated longer progression-free survival and better response rates than high doses of octreotide LAR alone. Additionally, the treatment is considered safe, with most positive responses occurring within about six months of starting treatment. Overall, these findings suggest that [177Lu]Lu-DOTA-TATE with octreotide LAR is a promising option for managing advanced gastroenteropancreatic neuroendocrine tumors.12346
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for patients with advanced Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have a high disease burden. Eligible participants should have large primary tumors or metastases, elevated alkaline phosphatase levels, peritoneal metastasis, symptoms like pain and weight loss, bone metastasis, hormone excess symptoms needing management, and be diagnosed within the last 6 months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive [177Lu]Lu-DOTA-TATE plus octreotide LAR or octreotide LAR alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and other long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- [177Lu]Lu-DOTA-TATE
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD