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    DRUG:

    Lutathera (lutetium Lu 177 dotatate)

    i
    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:
    3d
    A multicenter phase II randomized controlled trial comparing 177Lu-Dotatate/capecitabine combination treatment with 177Lu-Dotatate monotherapy in patients with neuroendocrine tumors. (PubMed, Clin Cancer Res)
    In this prematurely closed phase II study, 177Lu-Dotatate/capecitabine did not improve ORR or prolong PFS and OS in advanced NET patients compared to 177Lu-Dotatate alone and was associated with reduced QALYs.
    P2 data • Journal
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    capecitabine • Lutathera (lutetium Lu 177 dotatate)
    10d
    Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma (clinicaltrials.gov)
    P2, N=130, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2027 --> Jan 2033 | Trial primary completion date: Jan 2026 --> Jan 2030
    Trial completion date • Trial primary completion date
    |
    NF1 (Neurofibromin 1) • VHL (von Hippel-Lindau tumor suppressor) • SSTR (Somatostatin Receptor)
    |
    RET mutation • VHL mutation
    |
    Lutathera (lutetium Lu 177 dotatate)
    11d
    Expanding the therapeutic horizon of 177Lu-DOTATATE: a review of current evidence. (PubMed, Nagoya J Med Sci)
    Considering that SSTR expression is also present in various other tumors-including pheochromocytomas, paragangliomas, meningiomas, and medullary thyroid carcinomas-there is increasing interest in expanding the use of PRRT to other SSTR-positive malignancies. This review aimed to present evidence, explore ongoing clinical research, and highlight emerging directions for 177Lu-DOTATATE therapy beyond gastroenteropancreatic NETs.
    Review • Journal
    |
    SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
    |
    SSTR positive
    |
    Lutathera (lutetium Lu 177 dotatate)
    14d
    MOMENTUM-1: Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment (clinicaltrials.gov)
    P2, N=153, Recruiting, RTOG Foundation, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SSTR2 (Somatostatin Receptor 2)
    |
    Avastin (bevacizumab) • sunitinib • everolimus • hydroxyurea • Lutathera (lutetium Lu 177 dotatate)
    14d
    A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab (clinicaltrials.gov)
    P1/2, N=140, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=200 --> 140
    Enrollment closed • Enrollment change
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Lutathera (lutetium Lu 177 dotatate)
    15d
    A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent. (clinicaltrials.gov)
    P1, N=65, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Jul 2026 --> Jul 2027
    Enrollment closed • Trial completion date
    |
    temozolomide • Lutathera (lutetium Lu 177 dotatate)
    15d
    Predicting eligibility for outpatient 177Lu-DOTATATE-targeted radionuclide therapy in patients with neuroendocrine tumors. (PubMed, Nucl Med Commun)
    The whole-body washout rate derived from pretreatment SSTR imaging is a strong, practical predictor for outpatient eligibility following 177Lu-DOTATATE TRT. Incorporating this simple, noninvasive marker into clinical workflow could support individualized discharge planning and improve patient access under strict radiation safety regulations.
    Journal
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    Lutathera (lutetium Lu 177 dotatate)
    16d
    NELMAS: Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases (clinicaltrials.gov)
    P2, N=1, Terminated, Imperial College London | N=106 --> 1 | Trial completion date: Mar 2029 --> Oct 2025 | Recruiting --> Terminated | Trial primary completion date: Sep 2028 --> Oct 2025; The study has closed earlier than planned due to one of the funders decision to withdraw the financial support for the study.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    SSTR (Somatostatin Receptor)
    |
    Lutathera (lutetium Lu 177 dotatate)
    18d
    Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells (clinicaltrials.gov)
    P2, N=30, Recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • SYP (Synaptophysin) • CHGA (Chromogranin A)
    |
    Lutathera (lutetium Lu 177 dotatate)
    22d
    Iodine-Negative Rare Gluteal Muscle Metastasis of Papillary Thyroid Cancer: Detected by 68 Ga-DOTATATE PET/MRI and 18 F-FDG PET/CT. (PubMed, World J Nucl Med)
    The patient, who was unresponsive to RAI therapy, was being evaluated for suitability for 177 Lu-DOTATATE therapy...Muscle metastases are extremely rare for PTC. This case exemplifies the different levels of tumoral affinity shown by aggressive variants of PTC across three distinct imaging modalities: 68 Ga-DOTATATE PET/MRI, 18 F FDG PET/CT, and whole-body iodine scintigraphy.
    Journal
    |
    TG (Thyroglobulin)
    |
    Lutathera (lutetium Lu 177 dotatate)
    1m
    Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P2, N=94, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Nov 2025 --> Dec 2026 | Trial primary completion date: Nov 2025 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Lutathera (lutetium Lu 177 dotatate) • Triapine (3-AP)
    1m
    SALUS: Post-Authorization Long-Term Safety Study of LUTATHERA (clinicaltrials.gov)
    P=N/A, N=1014, Active, not recruiting, Advanced Accelerator Applications | Trial completion date: Jun 2028 --> Sep 2027 | Trial primary completion date: Jun 2028 --> Sep 2027
    Trial completion date • Trial primary completion date
    |
    SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    Lutathera (lutetium Lu 177 dotatate)