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

Researching [177Lu]Lu-DOTA-TATE for advanced GEP-NET safety and effectiveness.

Recruiting
12 years and older
All
Phase 3
**Study Overview**: This research is looking at how effective and safe a treatment called [177Lu]Lu-DOTA-TATE is for patients with certain types of tumors called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). These tumors are in the digestive system and can be advanced, meaning they have spread a lot or can't be removed by surgery. The study is comparing [177Lu]Lu-DOTA-TATE with another treatment called octreotide LAR, which is already used for these tumors. *GEP-NETs* are a type of cancer that affects hormone-producing cells in the stomach, pancreas, and intestines. *Octreotide LAR* is a medication given as an injection to help control symptoms from these tumors. **Key Points**: 1. **Study Phases**: This study has three parts: screening, treatment, and follow-up. 2. **Eligibility**: Participants must be at least 12 years old, with specific tumor conditions, and have not received certain treatments before. 3. **Treatment Details**: Participants will receive either [177Lu]Lu-DOTA-TATE plus octreotide LAR or octreotide LAR alone. This study will help understand if adding [177Lu]Lu-DOTA-TATE offers better results compared to the standard treatment.
Study details
    Somatostatin Receptor Positive (SSTR+)
    Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)

NCT06784752

Novartis Pharmaceuticals

14 March 2026

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