[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grupo Espanol de Tumores Neuroendocrinos\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,74,100,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100509812","phase-3-efficacy-and-safety-of-radiotherapy-compared-to-everolimus-in-somatostatin-receptor-positive-neuroendocrine-tumors-of-the-lung-and-thymus-100509812",false,"NCT05918302","Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.","Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.","LEVEL","Inclusion Criteria:\n\n1. Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written informed consent.\n2. Patients ≥ 18 years of age.\n3. Patients who have histologically confirmed metastatic or locally advanced unresectable well\u002Fmoderately differentiated; World Health Organization (WHO\\]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning.\n4. Patients must have the appropriate pathological features based on WHO classification, and description of proliferation activity as indicated by mitotic count per 10 high-power fields (HPF) and presence of necrosis, or Ki67 index.\n5. In SSTR imaging all RECIST v1.1 selected target lesions and all other lesions considered dominant by the investigator should be positive. If an fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET) is performed (not mandatory), all FDG-PET positive RECIST v1.1 target lesions and all other FDG-PET positive lesions considered dominant by the investigator should also be positive in SSRT imaging.\n6. Lesions must have shown radiological evidence of disease progression in the 12 months prior to inclusion in the study. Patients who were receiving systemic anticancer therapy, progression should be documented on therapy or after stopping therapy due to adverse events or other reasons. Patients without prior therapy, documentation of progression is also mandatory to watch and wait strategy or during the follow up after surgery.\n7. Patients may be included in first-line therapy (systemic treatment naïve) or may have experienced progression on somatostatin analogues or additional systemic treatments, which may include but not limited to chemotherapy, targeted agents or immunotherapy (maximum of 2 prior systemic anti-tumor treatments).\n\n   Note: Somatostatin analogues for patients with functioning tumors are allowed.\n8. Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1.\n9. An archival tumor tissue sample should be available for submission to the central laboratory prior to study treatment (36 months). If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided if feasible.\n10. Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n11. Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria:\n\n    1. Neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n    2. Platelet count ≥ 75 × 10\\^9\u002FL\n    3. Hemoglobin ≥ 8 g\u002FdL\n    4. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases\n    5. Creatinine clearance (CrCl) ≥ 40 mL\u002Fmin as estimated by the Cockcroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed.\n    6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases\n12. Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%) for the duration of the study treatment and for 6 months after the final dose of study treatment.\n13. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n14. Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n15. Male patients with a pregnant or breastfeeding partner(s) must agree to abstinence or use a condom for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for at least 6 months after the final study drug administration.\n16. Subject agrees not to participate in another interventional study while on treatment in the present study.\n\nExclusion Criteria:\n\n1. Patients who are not able to swallow tablets.\n2. Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible.\n3. Patients with brain mets unless stable on treatment for \\> 12 weeks and with no evidence of raised intracranial pressure or mass effect.\n4. Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).\n5. Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.\n6. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) RNA \\[qualitative\\] is detected). Patients who have a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).\n7. Patients who have received a live vaccine up to 4 weeks prior to the first dose of trial treatment.\n\n   Note:Live attenuated vaccines should not be administered during the trial treatment and over the next 3 months after the last treatment dose.\n8. Patients who have documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug.\n9. Prior peptide receptor radionuclide therapy (PRRT) or mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.); or hepatic radio-embolization (within 6 months prior to first dose of study treatment).\n10. Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug.\n11. Patients who have had chemotherapy, biologics, investigational agents, and\u002For antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug.\n12. Patients who have known hypersensitivity to Everolimus or to any excipient contained in the drug formulation of Everolimus.\n13. Patients who have known hypersensitivity to 177Lu-edotreotide or to any excipient contained in the drug formulation of 177Lu-edotreotide or the nephroprotective amino acid solution (AAS).\n14. Current spontaneous urinary incontinence preventing safe administration of the investigational medicinal product (IMP), in the investigator's opinion.\n15. Patients who have other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up.","ALL","18 Years",{"count":20,"type":21},170,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.",[27,28,29],"Neuroendocrine Tumors","Lung Neuroendocrine Neoplasm","Thymus Neoplasms","RECRUITING","2026-05-08",{"date":33,"type":34},"2026-05-12","ACTUAL",{"date":36,"type":34},"2023-10-27",{"date":38,"type":21},"2029-10",{"name":40,"class":41},"Grupo Espanol de Tumores Neuroendocrinos","OTHER",27,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100597637","phase-2-refractory-advanced-digestive-neuroendocrine-carcinomas-treated-with-tarlatamab-100597637","NCT07061080","Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab","Phase II Study Of Tarlatamab Alone Or In Combination With Chemotherapy In Advanced Neuroendocrine Carcinomas Of The Digestive System Or Unknown Primary Origin","RAGNAR","Inclusion Criteria:\n\n1. Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written informed consent.\n2. Patient is ≥ 18 years of age.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n4. Histologically confirmed neuroendocrine carcinomas (NECs) of the digestive system or unknown primary origin.\n\n   Note: Carcinomas of pulmonary origin are not eligible.\n5. Ki-67 \\>20% or mitotic rate \\> 20 per 10 HPF.\n6. Metastatic or locally advanced unresectable disease in the second-line treatment, after progression to either:\n\n   1. first-line therapy with platinum-based chemotherapy,\n   2. first-line combination of immunotherapy chemotherapy (excluding BITE CD3\u002FDLL3).\n7. At least one measurable lesion as defined by RECIST V1.1 (Appendix 3).\n8. Only patients with tumors positive for DLL3 as determined by the central laboratory are eligible. DLL3 positivity is defined as ≥1% of DLL3-expressing cells.\n\n   Note: An archival tumor tissue sample (frozen tumor block or 15 unstained formalin fixed, paraffin embedded \\[FFPE\\] slides) should be available for submission to the central laboratory for the determination of DLL3. Patients will sign a screening ICF and tumor samples will be sent to the central laboratory for assessing DLL3. Patients who do not have archived tumor tissue available should undergo tumor biopsy.\n9. Adequate organ function as defined below\n\n   1. Neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n   2. Platelet count ≥ 100 × 109\u002FL.\n   3. Hemoglobin ≥ 9 g\u002FdL.\n   4. Prothrombin time (PT)\u002FINR and Partial Thromboplastin Time (PTT) or Activated Partial Thromboplastin Time (APTT) 1.5 x upper limit of normal (ULN). Patients on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor.\n   5. Serum bilirubin ≤ 1.5 × ULN or 2 X ULN for subjects with liver metastases. Note: patients with Gilbert's disease are excluded.\n   6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤ 5 xULN for patients with liver metastases.\n   7. Creatinine clearance (CrCl) ≥ 40 mL\u002Fmin as estimated by the Cockroft-Gault formula or as measured by 24 hour urine collection (GFR can also be used instead of CrCl) (see Table 10 for Cockcroft-Gault formula).\n\n      10\\. Female patients must either:\n\n   a. Be of nonchildbearing potential: i. Postmenopausal \\*(defined as at least 1 year without any menses) prior to screening , or i.i. Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).\n\n   \\*Those who are amenorrheic due to an alternative medical cause are not considered postmenopausal and must follow the criteria for childbearing potential subjects.\n\n   OR b. If of childbearing potential: i. Agree not to try to become pregnant during the study and for at least 60 days after the last dose of tarlatamab, and 6 months after FOLFIRI.\n\n   i.i.And have a negative urine or serum pregnancy test within 7 days prior to Day 1, i.i.i. And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective birth control (Appendix 4) starting at screening and throughout the study period and for 60 days after the last dose of tarlatamab and 6 months after FOLFIRI.\n\n(11) Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for 60 days after the last dose of tarlatamab and 6 months after FOLFIRI.\n\n(12) Male patients must not donate sperm starting at screening and throughout the study period, and for 60 days after the last dose of tarlatamab and 6 months after FOLFIRI.\n\n(13) Male patients with a partner with childbearing potential, or who is pregnant or breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for 60 days after the last dose of tarlatamab and 6 months after FOLFIRI.\n\n(14) Patient agrees not to participate in another interventional study while on treatment in the present study.\n\nExclusion Criteria:\n\n1. The following endocrine tumor types may not be included:\n\n   1. Paraganglioma, adrenal, thyroid parathyroid or pituitary endocrine tumors,\n   2. Large or small cell lung neuroendocrine carcinoma of the lung,\n   3. Neuroendocrine tumors (NETs) of the gastrointestinal tract or unknown origin (i.e. well differentiated tumors)\n2. History of other malignancy within the past 2 years prior to first dose of tarlatamab except:\n\n   1. Malignancy (other than in situ) treated with curative intent and with no known active disease present for 2 years before first dose of tarlatamab and felt to be at low risk for recurrence by the treating physician.\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   3. Adequately treated in situ cancer without evidence of disease.\n   4. Prostatic intraepithelial neoplasia without evidence of prostate cancer.\n   5. Adequately treated urothelial papillary non-invasive carcinoma.\n3. Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab.\n4. Persistence of any toxicity from prior anti-tumor therapy that has not been resolved to grade ≤ 1 (NCI CTCAE V5.0) or to levels dictated in the eligibility criteria.\n\n   Note: exception is made with: i) alopecia; ii) grade ≤ 2 neurotoxicity from platinum based chemotherapy or; iii) irreversible toxicities not otherwise described in the exclusion criteria which are stable for ≥ 21 days after consultation with the medical monitor.\n5. Major surgery within 28 days of first dose tarlatamab.\n6. Radiation therapy \\\u003C 2 weeks prior to starting study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.\n7. Myocardial infarction, and\u002For symptomatic congestive heart failure (New York Heart Association class II) within 12 months of first dose of tarlatamab.\n8. Cardiac ejection fraction \\\u003C 50%, presence of clinically significant pericardial effusion or clinically significant electrocardiogram findings.\n9. History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.\n10. History of solid organ transplantation.\n11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab.\n12. Patients who experienced severe, life-threatening or recurrent (grade 2 or higher) immune-mediated adverse events or infusion-related reactions from previous treatments.\n13. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n14. Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n15. History of hypophysitis or pituitary dysfunction.\n16. Acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.\n17. Positive tests for Hepatitis B (HBVsAg) or Hepatitis C ribonucleic acid (HCVab) indicating acute or chronic infection.\n18. Live and live-attenuated vaccination are prohibited within 28 days prior to the first dose of tarlatamab treatment and for the duration of study.\n\n    Note: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination should be avoided during screening at least 14 days prior to the first day of tarlatamab treatment. Monkeypox infection vaccination is allowed during the study (except during cycle 1).\n19. Patient has known sensitivity and immediate hypersensitivity to any components of tarlatamab or FOLFIRI.\n20. Pregnant or breastfeeding patients, and patients planning to become pregnant during the study period and same windows as scheduled for contraceptive measures.\n21. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor, if consulted, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion",{"count":52,"type":21},87,[54],"PHASE2","Neuroendocrine neoplasms (NENs) comprise a heterogeneous family of neoplasms arising from the neuroendocrine cells localized in endocrine glands or from the diffuse neuroendocrine cells such as in the digestive or lung tract.\n\nTreatment for gastroenteropancreatic neuroendocrine tumors (GEP-NEC) is primarily based on chemotherapy regimens, primarily platinum, which achieve limited benefit and a median overall survival of approximately 12 months.\n\nCurrently, new treatments that activate the immune system to stimulate antitumor responses and prolong survival in patients with NECs are being investigated.\n\nGiven the high levels of DLL3 expression on the cell surface of neuroendocrine tumor cells and its minimal, primarily cytoplasmic, localization in normal tissues, DLL3 is a promising target for the development of T-cell-directed therapies in NECs. Tarlatamab is a HLE BiTE molecule that combines the binding specificities for DLL3 and CD3, which could activate the immune system to fight NEC cells.\n\nThe main hypothesis is that treatment with tarlatamab, a bispecific anti-DLL3 and anti-CD3 conjugate, either as a single agent or in combination with standard second-line chemotherapy (FOLFIRI) scheme could be an effective treatment option for patients with advanced neuroendocrine carcinomas of the digestive system or unknown primary origin.",[57,58],"Advanced Neuroendocrine Carcinomas of The Digestive System","Advanced Neuroendocrine Carcinomas Unknown Primary Origin",[60,61,62,63,64],"Digestive Neuroendocrine carcinomas","Tarlatamab","FOLFIRI","NECs","GEP-NEN","2026-02-02",{"date":67,"type":34},"2026-02-04",{"date":69,"type":34},"2025-12-18",{"date":71,"type":21},"2028-12",{"name":40,"class":41},19,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100583618","phase-3-randomized-interval-assessment-trial-of-lu177-dotatate-in-slowly-progressive-g1-2-advanced-midgut-neuroendocrine-tumors-100583618","NCT06878664","Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors","Randomized Interval Assessment Trial of Lu177-Dotatate Every 8 Versus Every 16 Weeks in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors (NETs) to Lower TOxicity","RIALTO","Inclusion Criteria:\n\n1. Patients who have histologically confirmed diagnosis of unresectable, advanced or metastatic midgut NETs (originated in the jejunum-ileum or right colon) who are candidates to receive 177Lu-Dotatate targeted radioligand therapy (RLT) and SSA. Patients with a large SRI+ mesenteric mass with abdominal-dominant disease judged by the investigator to be a midgut NET will also be eligible.\n2. Ki-67 index ≤ 20%.\n3. Disease progression per RECIST v1.1 within 36 months prior to study entry,\n4. Patients may be treatment naïve (first-line) or have received prior systemic therapy except for any type of prior RLT (not restricted to 177Lu-Dotatate).\n5. In somatostatin receptor (SSTR) imaging all RECIST v1.1 evaluable target lesions and non-target lesions need to be SSTR positive (SSTR+) as defined by equal or above the liver uptake (this includes lesions of at least 10 mm in diameter in CT or MRI). If an FDG PET is performed (not mandatory), all FDG PET positive lesions should also be somatostatin receptor positive in SSRT imaging (see guidance Appendix 10).\n6. Measurable disease according to RECIST v1.1 criteria (Appendix 3)\n7. Adequate organ function (hematological, renal and liver) based upon meeting all of the following laboratory criteria:\n\n   * Neutrophil count (ANC) ≥ 2.000\u002Fmm3\n   * Platelet count ≥ 75 × 109\u002FL\n   * Hemoglobin ≥ 8 g\u002FdL\n   * Serum bilirubin ≤ 3.0 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease\n   * Serum albumin \\\u003C3.0 g\u002FdL unless prothrombin time is within the normal range.\n   * Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin as estimated by the Cockroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed.\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 xULN for subjects with liver metastases\n8. Karnofsky performance status (KPS) scale ≥ 70%\n9. Patient information and signing of the consent form, Institutional Review Board(IRB)\u002FIndependent Ethics Committee (IEC) approved, before any study-specific procedure. The patient must be able and willing to cooperate in monitoring study visits and procedures.\n10. Patients ≥ 18 years of age.\n11. Recovery to Grade ≤ 1 from any adverse event (AE) from prior treatment (excluding alopecia and\u002For asthenia).\n12. Life expectancy ≥ 12 months.\n13. Patients with health coverage (public or private), that includes coverage for patients enrolled in clinical trials, to both study treatments and determinations\u002Fprocedures.\n14. Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%; refer to Appendix 4) for the duration of the study treatment and for 7 months after the final dose of study treatment. Sexually active men must agree to use the male condom during the study and until at least 7 months after the last administration of treatment. Additionally, it is recommended that your female partner of childbearing age use a highly effective method of contraception.\n15. Subject agrees not to participate in another interventional study while on treatment in the present study.\n\nExclusion Criteria:\n\n1. Patients who have known hypersensitivity to lutetium-177 (177Lu), oxodotreotide, DOTA, somatostatin analogues, lysine, arginine, or any excipient\u002Fderivative of these agents\n2. Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow\n3. Prior whole liver internal radiation therapy (SIRT)\n4. Prior radioligand therapy (RLT) (not restricted to 177Lu-Dotatate).\n5. Prior major surgery, systemic therapy, embolization or other locoregional treatments within 4 weeks of study entry\n6. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Patients who have a known active history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).\n7. Other known malignancies unless cured or definitively treated with no evidence of recurrence for 3 years\n8. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune, cardiovascular or dementia), that may interfere with the objectives of the trial or with the safety or compliance of the patient, as judged by the investigator.\n9. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 7 months after the final study drug administration.\n10. Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 4 months after the final study drug administration.\n11. Pregnancy or lactation. Men and women should not procreate during study treatment and until seven months after the final study drug administration.\n12. For female patients of childbearing potential (defined as \\\u003C 2 years after last menstruation and not surgically sterile) and male patients who are not surgically sterile and have female partners of childbearing potential that do not agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%; refer to Appendix 4) for the duration of the study treatment and for 7 months after the final dose of study treatment\n13. Patient under guardianship or curatorship or deprived of liberty by a judicial or administrative decision or patient unable to give consent.",{"count":83,"type":21},166,[24],"This is a randomized Phase II\u002Flate phase I de-escalation clinical trial with approved investigational medicinal products in new use condition, low intervention.\n\nDisease under study Patients with unresectable or metastatic, slowly progressive, well-differentiated (Grade1 and Grade2), somatostatin receptor-positive midgut neuroendocrine tumors (GEP-NETs).\n\nIt is planned to randomize 166 patients with a histologically confirmed diagnosis of slowly progressive grade 1 or grade 2 advanced midgut neuroendocrine tumors (NETs) candidates to receive 177Lu-Dotatate targeted radioligand therapy (RLT). Patients are required to have SSTR+ disease, as evidenced on somatostatin receptor imaging. Patients will be randomized into two arms:\n\n1. control arm: regimen 177Lu-Dotatate every 8 weeks (q8w)\n2. experimental arm: regimen 177Lu-Dotatate every 16 weeks (q16w)\n\nResearch hypothesis: Less intensive somatostatin-receptor (SST) targeted radioligand therapy (RLT) (7.4 GBq\u002Fcycle 177Lu-Dotatate every 16 weeks x 4 cycles) is associated with less severe hematological toxicities and may mitigate the risk to develop therapy-related myeloid neoplasms (t-MN) with similar antitumor efficacy in slowly growing gastrointestinal grade 1-2 NETs.",[87],"Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs)",[89,27,90],"midgut","Lu177-Dotatate","2025-08-29",{"date":93,"type":34},"2025-09-02",{"date":95,"type":34},"2025-06-12",{"date":97,"type":21},"2029-01",{"name":40,"class":41},21,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100534160","phase-2-sacituzumab-govitecan-in-thyroid-cancers-100534160","NCT06235216","Sacituzumab govitEcan in THYroid Cancers","A Multicenter, Open Label, Two Cohort, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of the Anti-TROP2 Antibody-drug Conjugate Sacituzumab Govitecan in Patients With Advanced Differentiated and Anaplastic Thyroid Neoplasms.","SETHY","Inclusion Criteria:\n\n1. Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written informed consent.\n2. Patient is ≥ 18 years of age.\n3. Patient has histologically confirmed metastatic or locally advanced unresectable radioactive-iodine refractory differentiated thyroid cancer (cohort A) or anaplastic thyroid carcinoma (cohort B).\n4. Prior therapy in each cohort:\n\n   1. Cohort A: Patients must have experienced progression on at least one previous treatment line with approved systemic therapies (Sorafenib, Lenvatinib or Cabozantinib) and a maximum of 3 prior systemic therapies.\n   2. Cohort B: Patients should be included in first-line setting or after failure of any systemic therapy (up to 1 prior treatment lines).\n5. Patient has radiographically documented and measurable metastatic or locally advanced disease at baseline.\n6. An archival tumor tissue sample should be available for submission to the central laboratory for translational studies. If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided. No central pathological review will be needed to include the patient in the trial.\n7. Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. The following baseline laboratory data without transfusional support:\n\n   1. Neutrophil count (ANC) ≥ 1,500\u002Fmm3.\n   2. Platelet count ≥ 100 × 109\u002FL.\n   3. Hemoglobin ≥ 9 g\u002FdL.\n   4. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN). Note: patients with Gilbert's disease are excluded.\n   5. Serum albumin \\> 3 g\u002FdL.\n   6. Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin as estimated by the Cockroft-Gault formula or as measured by 24 hour urine collection (GFR can also be used instead of CrCl).\n   7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 xULN for patients with liver metastases.\n9. Female patients must either:\n\n   1. Be of nonchildbearing potential:\n\n      I)Postmenopausal \\*(defined as at least 1 year without any menses) prior to screening , or II) Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).\n\n      \\*Those who are amenorrheic due to an alternative medical cause are not considered postmenopausal and must follow the criteria for childbearing potential subjects.\n\n      OR\n   2. If of childbearing potential:\n\n   I) Agree not to try to become pregnant during the study and for at least 6 months after the final study drug administration, II) And have a negative urine or serum pregnancy test within 7 days prior to Day 1 (females with false positive results and documented verification of negative pregnancy status are eligible for participation), III) And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective birth control per locally accepted standards starting at screening and throughout the study period and for at least 6 months after the final study drug administration.\n10. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n11. Male patients must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n12. Male patients with a partner with childbearing potential, or who is pregnant or breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for at least 6 months after the final study drug administration.\n13. Patient agrees not to participate in another interventional study while on treatment in the present study.\n\nExclusion Criteria:\n\n1. Patient has central nervous system (CNS) metastases.\n2. Patient has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).\n\n   Note: if patients received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n3. Patient has a history of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.\n\n   Note: Patients with non melanoma skin cancer, curatively treated localized prostate cancer, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n4. Patient has known active Hepatitis B or active hepatitis C:\n\n   1. Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n   2. Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n   3. Patients who test positive for HIV antibody.\n5. Patient has a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n6. Patient has documented history of a cerebral vascular event (stroke or transient ischemic attack), or the following criteria for cardiac disease:\n\n   1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment.\n   2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n   3. New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of \\\u003C 40%.\n7. Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months prior to the first dose of study drug.\n8. Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of gastrointestinal obstruction or perforation within 6 months of enrollment.\n9. Patient has uncontrolled hypertension or diabetes.\n10. Patient has radiotherapy or major surgery within 4 weeks prior to the first dose of study drug.\n11. Patients has received a live vaccine within 30 days, or antibiotics within one week prior to the first dose of study drug.\n12. Patient has had chemotherapy, biologics, investigational agents, and\u002For antitumor treatment with immunotherapy that is not completed 2 weeks prior to the first dose of study drug.\n\n    Note: Patients participating in observational studies are eligible.\n13. Patient has previously received topoisomerase 1 inhibitors.\n14. Patient has known hypersensitivity to sacituzumab govitecan or to any excipient contained in the drug formulation.\n15. Patient has other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.",{"count":109,"type":21},42,[54],"SETHY is a prospective, multicohort, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC).\n\nThe main hypothesis is that treatment with sacituzumab govitecan, a anti-Trophoblast cell surface antigen 2 (TROP-2), could be an effective treatment option for patients with either differentiated and anaplastic thyroid neoplasms because TROP-2 is highly expressed at the membrane of DTC and ATC.",[113,114],"Differentiated Thyroid Cancer","Anaplastic Thyroid Cancer",[116,117,118,119],"TROP-2","sacituzumab govitecan","Antibody-drug conjugate","SN-38","2024-10-31",{"date":122,"type":34},"2024-11-01",{"date":124,"type":34},"2024-09-13",{"date":126,"type":21},"2027-12",{"name":40,"class":41},11,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100344489","getne-registration-of-thyroid-cancer-100344489","NCT03765333","GETNE Registration of Thyroid Cancer","Descriptive Observational Epidemiological Study on the Characteristics of Thyroid Cancer in Patients Treated in Oncology Services of Spanish Centers: National Registry of Thyroid Cancer - Differentiated, Medullary and Anaplastic","Inclusion Criteria:\n\n* Patients older than 18 years with diagnosis of differentiated, medullary or anaplastic thyroid cancer confirmed by histopathology.\n* Patients who agree to participate and are able to understand the information sheet and sign the informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Patients with other types of thyroid cancer or whose histopathological diagnosis has not been confirmed.\n* Patients who do not have the relevant basic information to be included in the study, according to the criteria of the principal investigator.",{"count":137,"type":21},20,"OBSERVATIONAL","An epidemiological, observational, multicenter, cross-sectional, retrospective study on patients ≥ 18 years visited in the oncology services of the participating centers with diagnosis of primary thyroid cancer.",[141],"Thyroid Cancer","2024-10-02",{"date":144,"type":34},"2024-10-03",{"date":146,"type":34},"2019-05-28",{"date":148,"type":21},"2025-12",{"name":40,"class":41},1,""]