[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-neuroendocrine-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-neuroendocrine-neoplasm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,77,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100413603","phase-2-testing-lutetium-lu-177-dotatate-in-patients-with-somatostatin-receptor-positive-advanced-bronchial-neuroendocrine-tumors-100413603",false,"NCT04665739","Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors","Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors","Inclusion Criteria:\n\n* PRE-REGISTRATION: Pathologic Documentation: Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial origin (i.e. carcinoid) as assessed by local pathology\n\n  * The pathology report must state ONE of the following:\n\n    * Well- or moderately-differentiated neuroendocrine tumor,\n    * Low- or intermediate-grade neuroendocrine tumor, or\n    * Carcinoid tumor (including typical or atypical carcinoid tumors)\n* PRE-REGISTRATION: Documentation of histology from a primary or metastatic site is allowed\n* PRE-REGISTRATION: Functional (evidence of peptide hormones and\u002For bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome) or nonfunctional tumors are allowed\n* PRE-REGISTRATION: 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\n* PRE-REGISTRATION: Recurrent or locally-advanced\u002Funresectable or metastatic disease\n* PRE-REGISTRATION: Neuroendocrine tumor of bronchial (i.e. lung) primary site\n* PRE-REGISTRATION: Lesions must have shown radiological evidence of disease progression in the 12 months prior to pre-registration\n\n  * Tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to pre-registration; however, documentation of SSTR positivity in the 6 months prior to pre-registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions\n* PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy should not be considered measurable unless the lesion has clearly progressed since the procedure\n* PRE-REGISTRATION: Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \\>= 1 cm with CT or MRI (or \\>= 1.5 cm short axis for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung\n* REGISTRATION: Confirmation of SSTR positivity by Alliance Imaging Core Lab (ICL) at Imaging and Radiation Oncology Core (IROC) Ohio central radiographic review\n* REGISTRATION: Patients with treatment-naive or previously-treated disease are allowed. Patients with previously-treated disease must have demonstrated radiographic disease progression on the prior therapy\n* REGISTRATION: No prior treatment with peptide receptor radionuclide therapy (PRRT) (e.g. lutetium Lu 177 dotatate)\n* REGISTRATION: No prior treatment with mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.)\n* REGISTRATION: Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective radioembolization) or ablative therapies (i.e. cryoablation, radiofrequency ablation, etc.) is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site. Prior liver-directed (including ablative) treatment must be completed at least 28 days prior to registration\n* REGISTRATION: Prior treatment with 90-Yttrium radioembolization must be completed at least 6-weeks prior to registration\n* REGISTRATION: Radiation therapy to the lung and\u002For mediastinum must be completed at least 14 days prior to registration for stereotactic ablative and at least 28 days prior to registration for conventional fractionation\n* REGISTRATION: Prior treatment with systemic anticancer therapy must be completed at least 28 days prior to registration (except for somatostatin analogs in patients with functional tumors). Continuation of treatment with somatostatin analogs while on protocol therapy is allowed provided that the patient:\n\n  * Has functional tumors (evidence of peptide hormones and\u002For bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), and\n  * Has previously demonstrated radiographic disease progression while on somatostatin analog therapy\n* REGISTRATION: Patients must have completed any major surgery at least 28 days prior to registration. Complete wound healing from major surgery should occur prior to registration\n* REGISTRATION: Patients should have improvement of any toxic effects of prior therapy (except alopecia, fatigue, and other non-reversible toxic effects such as neuropathy from cisplatin) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1 or less\n* REGISTRATION: Not pregnant and not nursing\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 28 days prior to registration is required\n* REGISTRATION: Age \\>= 18 years\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* REGISTRATION: Hemoglobin \\>= 8.0 g\u002FdL\n* REGISTRATION: Platelet count \\>= 75,000\u002Fmm\\^3\n* REGISTRATION: Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* REGISTRATION: Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance \\>= 40 mL\u002Fmin\n\n  * Calculated by the Cockcroft-Gault equation\n* REGISTRATION: Total bilirubin =\\\u003C 2.0 x ULN\n\n  * In patients with Gilbert's syndrome, if total bilirubin is \\> 2.0 x ULN, then direct bilirubin must be =\\\u003C 2.0 x ULN\n* REGISTRATION: Albumin \\>= 2.8 g\u002FdL\n* REGISTRATION: Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3.0 x ULN\n* REGISTRATION: No known central nervous system metastases unless treated and clinically stable for at least 14 days prior to registration. Patients on steroid support must be clinically stable on weaning doses of steroids\n* REGISTRATION: No other currently active malignancy that requires therapy or is expected to require therapy during the study (excluding non-melanoma skin cancers or in situ carcinomas, such as breast or cervical)\n* REGISTRATION: No known active hepatitis B (defined as hepatitis B surface antigen \\[HbsAg\\] reactive) or known active hepatitis C virus (defined as hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] viral load detected). The exception is for patients with known active hepatitis B virus (defined as HbsAg reactive) infection, where the HBV viral load must be undetectable on suppressive therapy for patient to be eligible\n* REGISTRATION: Patients with known human immunodeficiency virus (HIV) infections on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* REGISTRATION: No known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to registration\n* REGISTRATION: No receipt of live attenuated vaccines in the 7 days prior to registration\n* REGISTRATION: No known decompensated liver cirrhosis\n* REGISTRATION: No known prior drug-induced pneumonitis that was symptomatic or required treatment\n* REGISTRATION: No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent\n* REGISTRATION: No known hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus, etc.)\n* REGISTRATION: Concurrent somatostatin analog use while on protocol therapy is allowed provided that the patient: 1) has a functional tumor (evidence of peptide hormones and\u002For bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), 2) has previously demonstrated radiographic disease progression while on somatostatin analog therapy\n* REGISTRATION: Chronic concomitant treatment with P-gp and strong CYP3A4 inhibitors and\u002For inducers is not allowed on the everolimus treatment arm of this study. Given that the study is randomized, all patients on P-gp and strong CYP3A4 inhibitors and\u002For inducers must discontinue the drug(s) 7 days prior to registration\n* RE-REGISTRATION: Confirmation of disease progression by RECIST v1.1 by real-time Alliance ICL at IROC Ohio central radiographic review\n* RE-REGISTRATION: Not pregnant and not nursing\n\n  * Women of childbearing potential only, a negative pregnancy test done =\\\u003C 28 days prior to re-registration is required\n* RE-REGISTRATION: ECOG performance status 0-2\n* RE-REGISTRATION: Hemoglobin \\>= 8.0 g\u002FdL\n* RE-REGISTRATION: Platelet count \\>= 75,000\u002Fmm\\^3\n* RE-REGISTRATION: Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* RE-REGISTRATION: Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance \\>= 40 mL\u002Fmin\n\n  * Calculated by the Cockcroft-Gault equation\n* RE-REGISTRATION: Total bilirubin =\\\u003C 2.0 x ULN\n\n  * In patients with Gilbert's syndrome, if total bilirubin is \\> 2.0 x ULN, then direct bilirubin must be =\\\u003C 2.0 x ULN\n* RE-REGISTRATION: Albumin \\>= 2.8 g\u002FdL\n* RE-REGISTRATION: AST\u002FALT =\\\u003C 3.0 x ULN","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.",[26,27,28,29,30,31,32,33,34,35,36,37],"Advanced Lung Neuroendocrine Tumor","Functioning Lung Neuroendocrine Tumor","Locally Advanced Lung Neuroendocrine Neoplasm","Lung Neuroendocrine Neoplasm","Lung Neuroendocrine Tumor G1","Lung Neuroendocrine Tumor G2","Metastatic Lung Neuroendocrine Neoplasm","Metastatic Lung Neuroendocrine Tumor","Non-Functioning Lung Neuroendocrine Tumor","Recurrent Lung Neuroendocrine Neoplasm","Unresectable Lung Neuroendocrine Neoplasm","Unresectable Lung Neuroendocrine Tumor","RECRUITING","2026-06-17",{"date":41,"type":42},"2026-06-18","ACTUAL",{"date":44,"type":42},"2023-02-03",{"date":46,"type":20},"2027-07-01",{"name":48,"class":49},"National Cancer Institute (NCI)","NIH",29,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100531612","phase-2-temozolomide-and-survivin-long-peptide-vaccine-survaxm-for-the-treatment-of-patients-with-progressing-metastatic-neuroendocrine-carcinomas-100531612","NCT06202066","Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas","A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Carcinomas (NECs)","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have a Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (i.e. the patient must be able to care for himself\u002F herself with occasional help from others)\n* Measurable, pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic, or thoracic origin with ki67\\>20% (well-differentiated G3 NETs) or neuroendocrine carcinoma of any origin excluding small cell lung carcinoma\n* Patients must have documented radiographic progression, determined as clinically significant by the treating provider, within the last twelve months on two CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria. In the case of retreatment, progression may be defined by the treating provider (e.g., clinical, radiographic, biochemical)\n* Patients must have failed at least one prior systemic therapy\n* Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment\n* Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (obtained within 14 days prior to enrollment)\n* Platelets ≥ 100 x 10\\^9\u002FL (obtained within 14 days prior to enrollment)\n* Hemoglobin (Hgb) \\> 9g\u002FdL (obtained within 14 days prior to enrollment)\n* Plasma total bilirubin: ≤ 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to enrollment)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 4 x ULN (obtained within 14 days prior to enrollment)\n* Creatinine clearance ≥ 60 mL\u002Fmin (per Cockroft-Gault equation) (obtained within 14 days prior to enrollment)\n* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \\[LMW\\] heparin) must meet the following criteria:\n\n  * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices, which carries a significant risk of bleeding in investigator's opinion)\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients who have received temozolomide in the advanced disease setting either alone or as part of a combination therapy will be excluded if they progressed while on it\n* Has received prior treatment with SurVaxM\n* Received an investigational agent within 30 days prior to enrollment\n* Participants who have received checkpoint inhibitors within 3 months prior to study enrollment or, those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bradycardia, tachycardia or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements and, which in the treating physicians' opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety\n* Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study\n* Known history of an autoimmune disorder\n* Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness\n* Systemic corticosteroid therapy \\> 2mg of dexamethasone or equivalent per day at study entry\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug\n* Patients with Hepatitis B or Hepatitis C may be included if there are adequately controlled viral titers and no drug-drug interactions, testing not required",{"count":59,"type":20},60,[23],"This phase IIa trial compares the safety and effect of temozolomide combined with survivin long peptide vaccine (SurVaxM) to temozolomide alone in patients with neuroendocrine tumors (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and is growing, spreading or getting worse (progressing). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Survivin, a protein, is expressed in 50% of patients that have neuroendocrine tumors and, is associated with poor outcomes. SVN53-67\u002FM57-KLH peptide vaccine (SurVaxM) is a vaccine that has been shown to produce an immune system response against cancer cells that express a survivin and may block the growth of new tumor cells. Giving temozolomide with SurVaxM may kill more tumor cells in patients with progressing metastatic neuroendocrine tumors.",[63,29,64,65],"Digestive System Neuroendocrine Neoplasm","Malignant Solid Neoplasm","Pancreatic Neuroendocrine Neoplasm","2026-05-27",{"date":68,"type":42},"2026-05-28",{"date":70,"type":20},"2026-07-15",{"date":72,"type":20},"2028-10-15",{"name":74,"class":75},"Roswell Park Cancer Institute","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100509812","phase-3-efficacy-and-safety-of-radiotherapy-compared-to-everolimus-in-somatostatin-receptor-positive-neuroendocrine-tumors-of-the-lung-and-thymus-100509812","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.",{"count":86,"type":20},170,[88],"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.",[91,29,92],"Neuroendocrine Tumors","Thymus Neoplasms","2026-05-08",{"date":95,"type":42},"2026-05-12",{"date":97,"type":42},"2023-10-27",{"date":99,"type":20},"2029-10",{"name":101,"class":75},"Grupo Espanol de Tumores Neuroendocrinos",27,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":76},"100431107","phase-2-a-trial-evaluating-the-activity-and-safety-of-combination-between-cabozantinib-and-temozolomide-in-lung-and-gep-nens-progressive-after-everolimus-sunitinib-or-prrt-cabotem-100431107","NCT04893785","A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)","A Phase II Single Arm Interventional Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)","CABOTEM","Inclusion Criteria:\n\n1. 18 years and older patients.\n2. Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient's awareness and willingness to comply with the study requirements.\n3. Documented histological or cytological diagnosis of well differentiated Lung and GEP-NENs (NET G1, NET G2, NET G3 in WHO 2017 classification) progressing after a first line of therapy with SSAs, sunitinib, everolimus, chemotherapy and\u002For PRRT or documented histological or cytological diagnosis of Large cells neuroendocrine carcinoma patients with Ki67\\\u003C 55% progressed after platinum-based first line chemotherapy.\n4. Subjects must have evidence of progressed disease, radiologically documented in the 12 months previous study entry.\n5. Subjects must have evidence of measurable disease as determined by the investigator. Target lesions must have shown evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria in the 12 months prior to study entry. Patients must have measurable disease per RECIST 1.1 by computer tomography (CT) scan or magnetic resonance imaging (MRI). Gallium 68 PET Scan can be considered useful before and during the treatment.\n6. Subject must have adequate swallowing capacity.\n7. Subjects with functional (associated with a clinical hormone syndrome) and non functional tumors are eligible for the study.\n8. The concurrent use of somatostatin analogues is allowed provided that the patient has been on a stable dose for at least two months.\n9. At least 4 weeks of wash-out from previous targeted therapies.\n10. At least 6 months of wash-out from previous PRRT treatment.\n11. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.\n12. Subjects must have adequate organ function, including the following:\n13. Bone marrow reserve consistent with: absolute neutrophil count (ANC) ≥1.5 x109\u002FL; platelet count ≥ 100 x 109\u002FL; haemoglobin ≥ 9 g\u002FdL;\n14. Hepatic: total bilirubin ≤ 1.5 x upper limit of normal (ULN), transaminases (aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase \\[AST\u002FSGOT\\] and alanine aminotransferase\u002Fserum glutamic pyruvic transaminase \\[ALT\u002FSGPT\\]) ≤ 2.5 x ULN (\\\u003C 5 x ULN if liver metastases are present);\n15. Renal: normal serum creatinine or calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockroft-Gault formula);\n16. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy.\n17. Estimated life expectancy of ≥12 weeks\n18. Sexually active fertile female subjects must agree to use effective contraceptive methods during the course of the study and for 4 months after the last dose of study treatment. While sexually active fertile male subjects must agree to use effective contraceptive methods during the course of the study and up to 6 months after the last dose of study treatment;\n19. For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration;\n20. Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures and willingness to comply with the study requirements.\n\nExclusion Criteria:\n\n1. Receipt of any type of anticancer therapy within 4 weeks before study entry.\n2. Previous treatment with Temozolomide or cabozantinib\n3. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before recruitment.\n4. Previous PRRT treatment: Systemic treatment with radionuclides within 6 months before study entry.\n5. Subjects with clinically relevant ongoing complications from prior radiation therapy and\u002For surgery are not eligible.\n6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery and stable for at least 3 months before study entry\n7. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.\n8. Chronic hepatitis B infection (both active or not).\n9. Chronic treatment with corticosteroids or other immuno-suppressive agents.\n10. Serious illness other than cancer including, but not limited to, the following conditions:\n\n    1. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i.e. Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction ii. Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before recruitment. Note: Complete healing of an intra-abdominal abscess must be confirmed prior to recruitment.\n    2. Cavitating pulmonary lesion(s) or endobronchial disease\n    3. Lesion invading a major blood vessel including, but not limited to: inferior vena cava, pulmonary artery, or aorta. Subjects with lesions invading the portal vasculature are eligible.\n    4. Clinically significant bleeding risk including the following within 3 months of recruitment:\n\n       hematuria, hematemesis, hemoptysis of \\>0.5 teaspoon (\\>2.5 mL) of red blood, or other signs indicative of pulmonary hemorrhage, or history of other significant bleeding if not due to reversible external factors\n    5. Other clinically significant disorders such as:\n\n    I. Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS)-related illness. II. Serious non-healing wound\u002Fulcer\u002Fbone fracture III. Malabsorption syndrome IV. Uncompensated\u002Fsymptomatic hypothyroidism V. Requirement for hemodialysis or peritoneal dialysis VI. History of solid organ transplantation\n11. Uncontrolled congestive heart failure (NYHA II, III, IV). Patients with history of congestive heart failure who do not violate this exclusion criterion will undergo an evaluation of their cardiac ejection fraction prior to recruitment, preferably via gated equilibrium radionuclide ventriculography. The results from an earlier assessment (not exceeding 30 days prior to recruitment) may substitute the evaluation at the discretion of the Investigator, if no clinical worsening is noted. The patient's measured cardiac ejection fraction in these patients must be \\>40% before recruitment.\n12. QTcF \\> 470 msec for females and QTcF \\> 450 msec for males or congenital long QT syndrome.\n13. Patients with rare hereditary problems of galattose intolerance, congenital lactase deficiency or glucose - galattose malabsorption.\n14. Major surgery within 3 months before study entry. Complete wound healing from major surgery must have occurred 1 month before study entry and from minor surgery at least 10 days before study entry.\n15. Pregnant or lactating females.\n16. History of another malignancy within 2 years before study entry, except for superficial skin cancers.\n17. Serious and\u002For unstable pre-existing medical or psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.\n18. Patients on chronic treatment with drugs that are contraindicated to with cabozantinib and temozolomide treatment according to the SmPC of each product.",{"count":112,"type":20},35,[23],"The aim of CABOTEM study is to demonstrate the safety and activity of the Cabozantinib and Temozolomide combination in Lung and GEP-NENs patients, progressing after a first line therapy, including target therapies (everolimus, sunitinib) and \u002F or chemotherapy, in the approved setting.",[29,116],"GEP Neuroendocrine Tumor","2024-06-17",{"date":119,"type":42},"2024-06-18",{"date":121,"type":42},"2021-06-15",{"date":123,"type":20},"2026-12",{"name":125,"class":75},"National Cancer Institute, Naples"]