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DRUG:

Lutathera (lutetium Lu 177 dotatate)

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Other names: 177Lu-DOTATATE, [Lu-177]-Dota-Tyr3-Octreotate, [Lu-177]-DOTATATE, octreotate Lu-177 DOTA Tyr-3, 177Lu-[DOTA0, Tyr3] octreotate, 177Lu-DOTA0-Tyr3-octreotate, Lu-DOTATATE, 177Lu-DOTA-Octreotate, 177Lu-DOTA-tyr3-Octreotate, AAA601, AAA 601, AAA-601, [177Lu]Lu-DOTA-TATE
Company:
Novartis
Drug class:
Beta radiation emitter, SSTR2 modulator
Related drugs:
5d
GoTHAM: Targeted Therapy and Avelumab in Merkel Cell Carcinoma (clinicaltrials.gov)
P1/2, N=19, Active, not recruiting, Melanoma and Skin Cancer Trials Limited | Recruiting --> Active, not recruiting | Trial completion date: Jul 2027 --> Dec 2027 | Trial primary completion date: Jul 2027 --> Dec 2026
Enrollment closed • Trial completion date • Trial primary completion date
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Bavencio (avelumab) • Lutathera (lutetium Lu 177 dotatate)
6d
[177Lu]Lu-DOTATATE Population Pharmacokinetics and Dosimetry Modeling for Adolescent and Adult Patients with Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors. (PubMed, J Nucl Med)
Age and weight did not show a clinically significant impact on 177Lu-DOTATATE exposure or kidney and bone marrow dosimetry values, confirming that flat dosing at adult dosage is appropriate for adolescents. 177Lu-DOTATATE with 7.4 GBq of activity, administered over 4 cycles 8 wk apart, is a well-tolerated therapeutic dosing regimen for adolescent patients with gastroenteropancreatic neuroendocrine tumors or pheochromocytomas and paragangliomas.
PK/PD data • Journal
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SSTR (Somatostatin Receptor)
|
SSTR positive
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Lutathera (lutetium Lu 177 dotatate)
12d
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors (clinicaltrials.gov)
P1, N=10, Recruiting, University of Wisconsin, Madison | Trial completion date: Mar 2026 --> Jun 2026 | Trial primary completion date: Mar 2026 --> Jun 2026
Trial completion date • Trial primary completion date
|
SSTR (Somatostatin Receptor)
|
SSTR positive
|
Lutathera (lutetium Lu 177 dotatate)
14d
KKS-312: Adjuvant radioligand therapy in neuroendocrine tumors (2024-518236-36-00)
P2/3, N=160, Recruiting, Philipps-Universitaet Marburg | Not yet recruiting --> Recruiting
Enrollment open
|
SSTR (Somatostatin Receptor)
|
Lutathera (lutetium Lu 177 dotatate)
16d
Trial primary completion date
|
temozolomide • Lutathera (lutetium Lu 177 dotatate)
19d
Medical Management of Well-Differentiated Pancreatic Neuroendocrine Tumors: From Conventional Therapies to Emerging Strategies. (PubMed, J Clin Med)
In patients with radiologic progression requiring systemic disease control, targeted agents such as everolimus and sunitinib represent established subsequent options, particularly when disease stabilization is the primary therapeutic goal. Peptide receptor radionuclide therapy with 177Lu-DOTATATE has demonstrated meaningful antitumor activity and is generally considered in patients with SSTR-positive tumors with progressive disease (Ki-67 ≥ 10%) or increasing tumor burdens, especially when tumor reduction is desirable. Combination cytotoxic chemotherapy, most notably the capecitabine-temozolomide (CAPTEM) regimen, remains an important consideration for patients with higher tumor burdens or more aggressive tumor biology. This review summarizes current evidence and provides a practical overview of treatment selection and sequencing for the systemic management of Grade 1-2 pancreatic neuroendocrine tumors, while also highlighting emerging therapeutic strategies, including targeted alpha therapy and SSTR2 antagonist-based approaches.
Review • Journal
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SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
|
SSTR positive
|
sunitinib • everolimus • temozolomide • capecitabine • Lutathera (lutetium Lu 177 dotatate)
21d
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (clinicaltrials.gov)
P1, N=31, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2027 --> Aug 2026 | Trial primary completion date: Jun 2027 --> Aug 2026
Trial completion date • Trial primary completion date
|
TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • SSTR2 (Somatostatin Receptor 2) • SYP (Synaptophysin) • CHGA (Chromogranin A)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
21d
Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma (clinicaltrials.gov)
P2, N=32, Active, not recruiting, NYU Langone Health | Trial primary completion date: Jan 2026 --> Apr 2025
Trial primary completion date
|
SSTR2 (Somatostatin Receptor 2)
|
Lutathera (lutetium Lu 177 dotatate)
22d
Recommendations for selection, treatment, and follow-up in peptide receptor radionuclide therapy (PRRT) for neuroendocrine tumors: a Delphi consensus from the Galician Multidisciplinary Group on Neuroendocrine and Endocrine Tumors (GGNET). (PubMed, Clin Transl Oncol)
This Delphi consensus provides pragmatic, multidisciplinary, and evidence-informed guidance to harmonize routine clinical practice in the use of PRRT for well-differentiated, SSTR-positive NETs. The proposed statements and the algorithm aim to harmonize practice across centers, reduce variability in care, enhance safety, and ultimately improve patient outcomes.
Journal
|
SSTR (Somatostatin Receptor)
|
SSTR positive
|
Lutathera (lutetium Lu 177 dotatate)
26d
Lung Metastases from Meningioma Diagnosed on Whole Body 68Ga-DOTATOC PET/CT and Successfully Targeted With 177Lu-DOTATATE. (PubMed, Clin Nucl Med)
We report a case of meningioma brain tumor becoming refractory after initial neurosurgery and stereotactic radiotherapy. Meningioma has progressed to lung metastases displaying high expression of SSTR, and hence suitable for PRRT.
Journal
|
SSTR (Somatostatin Receptor)
|
Lutathera (lutetium Lu 177 dotatate)
30d
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors. (clinicaltrials.gov)
P1, N=15, Recruiting, Emory University | Not yet recruiting --> Recruiting | Trial completion date: Sep 2026 --> Sep 2027 | Trial primary completion date: Sep 2025 --> Sep 2026
Enrollment open • Trial completion date • Trial primary completion date
|
SSTR (Somatostatin Receptor)
|
SSTR positive
|
Lutathera (lutetium Lu 177 dotatate)
1m
Peptide Receptor Radionuclide Therapy for Recurrent Neuroendocrine Tumor Liver Metastases After Liver transplantation: A Case Series. (PubMed, Transplant Proc)
PRRT combined with everolimus-based immunosuppression has demonstrated controllable safety and preliminary antitumor activity in patients with relapsed NETLM after LT who have been strictly screened, but myelosuppression requires close monitoring and timely symptomatic treatment.
Journal
|
SSTR (Somatostatin Receptor)
|
SSTR positive
|
everolimus • Lutathera (lutetium Lu 177 dotatate) • octreotide acetate