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    Association details:
    Biomarker:SSTR positive
    Cancer:Neuroendocrine Tumor
    Drug:Lutathera (lutetium Lu 177 dotatate) (Beta radiation emitter, SSTR2 modulator)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    GlobeNewswire
    Title:

    Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors

    Published date:
    04/23/2024
    Excerpt:
    Novartis...announced that the U.S. Food and Drug Administration (FDA) approved Lutathera® (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Novartis Press Release
    Title:

    Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

    Published date:
    09/25/2023
    Excerpt:
    Novartis announced the Phase III NETTER-2 trial with Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) met its primary endpoint. First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive...
    Secondary therapy:
    octreotide
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO-GI 2021
    Title:

    O-2 Overall survival and long-term safety data from the NETTER-1 trial: 177-Lu-Dotatate vs. high-dose octreotide in patients with progressive midgut NETs

    Published date:
    07/04/2021
    Excerpt:
    ...in patients with advanced, progressive, well-differentiated, somatostatin receptor-positive midgut neuroendocrine tumors (NETs)….Median OS was 11.7 months longer with 177Lu-DOTATATE compared to high-dose octreotide in the NETTER-1 trial (48 vs. 36.3 months).
    DOI:
    https://doi.org/10.1016/j.annonc.2021.05.006
    Trial ID:
    NETTER-1
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2021
    Title:

    Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors.

    Published date:
    05/19/2021
    Excerpt:
    Median OS was 48.0 months in the 177Lu-DOTATATE arm of the NETTER-1 trial and 36.3 months in the control arm. This difference was not statistically significant, potentially impacted by a high rate (36%) of cross-over of patients in the control arm to radioligand therapy after progression. In overall conclusion, the NETTER-1 study demonstrated that 177Lu-DOTATATE yielded a clinically and statistically significant improvement in PFS as a primary endpoint (HR: 0.18, p< 0.0001) as well as a clinically meaningful trend towards improvement in median OS of 11.7 months.
    DOI:
    10.1200/JCO.2021.39.15_suppl.4112
    Trial ID:
    NETTER-1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications

    Excerpt:
    ...Presence of unresectable or metastatic, well differentiated, somatostatin receptor positive non gastroenteropancreatic neuroendocrine tumours....
    Trial ID:
    NCT06121271
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea

    Excerpt:
    ...- somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults....
    Trial ID:
    NCT04946305
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    LUTATHERA Injection General Use Result Survey

    Excerpt:
    ...Somatostatin receptor-positive neuroendocrine tumor Patients who started to receive this drug before the contract for this study will also be included in the study population and it will be allowed to register them after the contract so that all patients who receive this drug will be included in this study....
    Trial ID:
    NCT05844332
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

    Excerpt:
    ...- Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor...
    Trial ID:
    NCT06122610
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

    Excerpt:
    ...- Patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET)....
    Trial ID:
    REAL-LU
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Post-Authorization Long-Term Safety Study of LUTATHERA

    Excerpt:
    ...- with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs...
    Trial ID:
    SALUS