Advanced Accelerator Applications S.A. ((AAAP)) announced an update on their ongoing clinical study.
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Advanced Accelerator Applications S.A. (AAAP) is conducting a Phase III study titled ‘A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET.’ The study aims to assess whether Lutathera, combined with long-acting octreotide, can extend progression-free survival in patients with high-grade gastroenteropancreatic neuroendocrine tumors (GEP-NET) compared to high-dose octreotide alone.
The intervention being tested is Lutathera, a radiopharmaceutical, administered alongside octreotide LAR. Lutathera is intended to target and treat neuroendocrine tumors by delivering targeted radiation therapy.
The study design is interventional with a randomized allocation and a crossover intervention model. It is an open-label study with no masking, primarily focused on treatment efficacy.
The study began on January 8, 2020, with an estimated primary completion date in July 2024 and an estimated study completion date in August 2025. The last update was submitted in August 2025, indicating ongoing progress.
This study update could positively impact AAAP’s stock performance by enhancing investor confidence in Lutathera’s potential market success. The results could also influence the competitive landscape in the neuroendocrine tumor treatment market.
The study is ongoing, and further details are available on the ClinicalTrials portal.