[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-neoplasms":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,76,97,123,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100369142","phase-1-lu-177-dotatate-lutathera-in-combination-with-olaparib-in-inoperable-gastroenteropancreatico-neuroendocrine-tumors-gep-net-100369142",false,"NCT04086485","Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)","Phase I\u002FII Study of Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)","* INCLUSION CRITERIA:\n* Clinical diagnosis of GEP-NET disease, histologically consistent with neuroendocrine tumor.\n* Inoperable disease (metastatic, non-candidate for surgery with curative intent, locally advanced into vessels or other critical structures, etc.)\n\nNOTE: Presence of at least one non-irradiated index lesion (Phase II only).\n\n* Patients on somatostatin analogue therapy (e.g., but not only limited to sandostatin or lanreotide therapy) must have initiated and been on a consistent dose of therapy for at least 3 months prior to study enrollment.\n* Patients on short-term octreotide must have dose held for 24 hours without octreotide because this is necessary for study Lu-177-DOTATATE therapy.\n* Age \\>=18 years. Because no dosing or adverse event data are currently available on the use of Lu-177-DOTATATE in combination with olaparib in patients \\\u003C18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.\n* Must have presence of somatostatin receptors (SSTR) positive disease as documented by positive Ga-68-DOTATATE PET scan within 12 weeks prior to enrollment. NOTE: Positivity of Ga-68-DOTATATE PET scan is defined as having at least one RECIST 1.1 measurable lesion that has an SUV higher than or equal to liver and is qualitatively higher and distinguishable from background activity.\n* Known BRCA mutation status (Cohort 3 only).\n* Progressive disease by RECIST 1.1, as compared to previous anatomic imaging no more than 36 months from the date of study enrollment, with at least 1 measurable lesion by RECIST 1.1.\n* ECOG Performance Status of \\\u003C=1.\n* Patients must have normal organ and bone marrow function measured within 28 days prior to enrollment as defined below:\n\n  * Hemoglobin \\>= 10.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n  * Platelet count \\>= 100 x 10\\^9\u002FL\n  * Total bilirubin \\\u003C= 1.5 x institutional upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) \\\u003C= 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be \\\u003C= 5x ULN\n  * Patients must have creatinine clearance estimated of \\>= 51 mL\u002Fmin using the Modification of Diet in Renal Disease (MDRD) study equation or based on a 24 hour urine test: eGFR = 175 x (SCr)\\^-1.154 x (age)\\^-0.203 x 0.742 \\[if female\\] x 1.212 \\[if Black\\]\n* Ability to understand and willingness to sign informed consent.\n* Postmenopausal or evidence of non-childbearing status. For individuals of childbearing potential (IOCBP): negative urine or serum pregnancy test within 28 days of study enrollment. Postmenopausal is defined as:\n\n  * Amenorrheic for 1 year (12 months in a row) or more without an alternative medical cause; if the individual received exogenous hormonal treatments, must be amenorrheic for 1 year or more following cessation of the same\n  * Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for individuals under 50\n  * Radiation-induced oophorectomy with last menses \\>1 year ago\n  * Chemotherapy-induced menopause with \\>1 year interval since last menses\n  * Surgical sterilization for IOCBP participants (bilateral oophorectomy or hysterectomy) and\u002For participants with partners that can bear children.\n* NOTE: An individual is not of childbearing potential if a prior history of hysterectomy with bilateral oophorectomy or other procedure has rendered the patient surgically sterile, or \\>1 years since last menstruation. Must have outside endocrinologist\u002Fmedical oncologist who can follow the patient for standard of care follow-ups after receiving PRRT at the NIH.\n* Study drugs can have adverse effects on embryofetal survival and development. It is further not known whether olaparib or its metabolites are found in seminal fluid. For these reasons:\n\n  * Individuals of childbearing potential and their partners, who are sexually active, must agree to the use of 2 highly effective forms of contraception in combination (male condom plus one of the methods listed below) or must totally\u002Ftruly abstain from any form of sexual intercourse. This should be started from the signing of the informed consent, throughout study treatment and for at least 7 month for individuals of childbearing potential after the last dose of the study drugs.\n  * Patients with partners that can bear children must use a male condom during treatment and for 4 months after the last dose of study drugs when having sexual intercourse with a pregnant individual or with an individual of childbearing potential. Partners of patients should also use a highly effective form of contraception (see below) if they are of childbearing potential. Patients should not donate sperm throughout study treatment and for 4 months following the last dose of study drugs.\n  * Acceptable birth control methods include:\n\n    * Total sexual abstinence i.e., refrain from any form of sexual intercourse in line with the patients' usual and\u002For preferred lifestyle. Abstinence must be for the total duration of the study treatment and for at least 7 months (for IOCBP) or 4 months (for patients with partners of child bearing potential) after the last dose of study treatment. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Vasectomised sexual partner PLUS male condom (with participant assurance that partner received post-vasectomy confirmation of azoospermia)\n    * Tubal occlusion PLUS male condom\n    * Intrauterine Device (provided coils are copper-banded) PLUS male condom\n    * Mini pill PLUS male condom: Progesterone-based oral contraceptive pill using desogestrel. Cerazette (Merck Sharp \\& Dohme) is currently the only highly efficacious progesterone- based pill available\n    * Combined pill PLUS male condom: Normal and low-dose combined oral pills\n    * Injection PLUS male condom: Medroxyprogesterone injection (eg, Depo-Provera \\[Pfizer\\])\n    * Implants PLUS male condom: Etonorgestrel-releasing implants (eg, Nexplanon \\[Merck Sharp \\& Dohme\\])\n    * Patch PLUS male condom: Norelgestromin\u002Fethinyl estradiol transdermal system (eg, Xulane)\n    * Intravaginal device (eg, ethinyl estradiol-\u002Fetonogestrel-releasing intravaginal devices such as NuvaRing \\[Merck Sharp \\& Dohme\\]) PLUS male condom\n    * Levonorgestrel-releasing intrauterine system (eg, Mirena \\[Bayer\\]) PLUS male condom.\n\nEXCLUSION CRITERIA:\n\n* Patients who have any GEP-NET lesions that are negative by Ga-68-DOTATATE-PET imaging but positive by FDG-PET imaging, unless they have progressed on at least one other line of prior systemic treatment (such as chemotherapy or tyrosine kinase inhibitor) and the majority of their tumor lesions are Ga-68-DOTATATE-avid.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued if the mother is treated with study drugs.\n* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.\n* Patients who are receiving any other investigational agents.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 4 weeks prior to study enrollment.\n* Patients with persistent toxicities (\\>= CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy and toxicities deemed irreversible\u002Fstable expected to interfere with study drug administration in the opinion of the Principal Investigator.\n* Patient's weight exceeding PET table tolerance (\\> 400 lbs).\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, hypertension (\\>180\u002F110), arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with symptomatic, uncontrolled brain metastases. NOTE: Patients with previously treated brain metastases are eligible if asymptomatic and may be on a stable dose of corticosteroids as long as these were started at least 4 weeks prior to treatment.\n* Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease by imaging and clinical assessment as assessed by the treating investigator for 28 days before enrollment.\n* Concomitant use of known strong or moderate CYP3A inhibitors within 2 weeks before enrollment.\n* Concomitant use of known strong or moderate CYP3A inducers within 5 weeks (for enzalutamide or phenobarbital) and 3 weeks for other agents before enrollment.\n* Patients that have had major surgery within 4 weeks prior to study enrollment and have not recovered from any effects of any major surgery.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Previous allogeneic hematopoietic stem cell transplant, allogeneic bone marrow transplant or double umbilical cord blood transplant (duCBT).\n* Patients with a known hypersensitivity to olaparib or Lutathera or any excipients of these products.\n* Resting ECG indicating uncontrolled cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML.\n* Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Patients with known active hepatitis (i.e., Hepatitis B or C).\n* Any previous treatment with PARP inhibitor, including olaparib and\u002For any previous treatment with any systemic radionuclide agents.\n* Involvement in the planning and\u002For conduct of the study.\n* Previous treatment with Lu-177-DOTATATE.","ALL","18 Years","100 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nA neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors.\n\nObjective:\n\nTo learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink.\n\nEligibility:\n\nAdults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells.\n\nDesign:\n\nEligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein.\n\nParticipants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses.\n\nDuring the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer.\n\nParticipants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls....",[28,29,30],"Gastroenteropancreatico Tumors","Neuroendocrine Tumors","Neuroendocrine Neoplasms",[32,33,34,35,36,37],"Somatostatin Receptors","Peptide receptor radionuclide therapy","Carcinoids","Radionuclide Therapy","olaparib","PARP Inhibitor","RECRUITING","2026-06-27",{"date":41,"type":42},"2026-06-30","ACTUAL",{"date":44,"type":42},"2022-10-03",{"date":46,"type":21},"2028-01-01",{"name":48,"class":49},"National Cancer Institute (NCI)","NIH",1,{"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":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100507028","phase-2-dareon-5-a-study-to-test-whether-different-doses-of-bi-764532-help-people-with-small-cell-lung-cancer-or-other-neuroendocrine-cancers-100507028","NCT05882058","DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers","DAREON™-5: An Open-label, Multi-center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-targeting T Cell Engager, in Patients With Relapsed\u002FRefractory Extensive-stage Small Cell Lung Cancer and in Patients With Other Relapsed\u002FRefractory Neuroendocrine Carcinomas","Inclusion criteria:\n\n1. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.\n3. Part 1: Histologically or cytologically confirmed, cancer of the following histologies:\n\n   * Small cell lung cancer (SCLC)\n   * Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC))\n   * Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma\u002Fsmall tumour cells component is predominant and represents at least 50% of the overall tumour tissue.\n\n   Patients must have progressed or recurred after standard of care therapy\n   * SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.\n   * Therapy includes PD-L1 inhibitor treatment; patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.\n   * epNEC\u002FLCNEC: after at least one platinum-based regimen. Part 2 and part 3: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status. Patients must have progressed or recurred after at least one platinum-based regimen.\n4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.,\n5. Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours (RECIST) v 1.1 within 21 days prior to the first dose of BI 764532.\n6. Part 1: Availability of archival tumour tissue sample Part 2 and part 3: Availability of archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. Following specimens are not allowed: Fine Needle Aspiration (FNA), Cytology samples, decalcified bone samples.\n7. Adequate organ function as defined in the protocol.\n8. All toxicities related to previous anti-cancer therapies have resolved = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and amenorrhea\u002Fmenstrual disorders which can be any grade).\n9. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information\n10. Only for Part 3, at the timepoint of Screening 02:\n\n    * For Cycle 1, patients should be willing to stay within 1 hour driving distance for 48 hours after IMP administration and confirm availability of a caregiver for the same timeframe.\n    * Patients should be considered suitable by the investigator to follow instructions applicable to the reduced monitoring cohort, such as taking their temperature and administration of oral medication at home if needed.\n\nExclusion criteria:\n\n1. Untreated or symptomatic brain metastases. (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria:\n\n   * Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532.\n   * Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease.\n2. Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.\n3. Part 1: Active\u002Fprevious history of interstitial lung disease or non-infectious pneumonitis (any grade).\n\n   Part 2 and part 3: Active\u002Fprevious history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible.\n4. Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.\n5. Prior anti-cancer therapy:\n\n   * Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.\n   * Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.\n6. Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.\n7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.\n8. Unresolved toxicity from prior anti-tumour therapy, defined in the inclusion criteria.\n\nFurther exclusion criteria apply.",{"count":59,"type":21},204,[25],"This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.\n\nThe purpose of this study is to find a suitable dose of BI 764532 (also called obrixtamig) that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3\u002FCD3 bispecific) that may help the immune system fight cancer.\n\nThe study has 3 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2 and Part 3, all participants receive the same dose of BI 764532. Part 2 and Part 3 are open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma.\n\nAll participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment.\n\nThe first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.",[63,30,64],"Small Cell Lung Carcinoma","Extra-pulmonary Neuroendocrine Carcinoma","2026-06-23",{"date":67,"type":42},"2026-06-24",{"date":69,"type":42},"2023-10-13",{"date":71,"type":21},"2028-02-24",{"name":73,"class":74},"Boehringer Ingelheim","INDUSTRY",59,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":50},"100513315","phase-1-a-study-to-test-how-bi-764532-is-taken-up-by-tumours-in-people-with-small-cell-lung-cancer-or-neuroendocrine-cancer-100513315","NCT05963867","A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer","An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma","Inclusion Criteria:\n\n* Age ≥18 years\n* Weight ≥ 60kg\n* Signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.\n* Patient who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy. Previous therapy with anti Programmed Cell Death Protein 1 (PD-1) or Programmed Cell Death Ligand 1 (PD-L1) are allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1\n* Subjects with brain metastases are eligible provided they meet the following criteria:\n\n  * radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532,\n  * patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant CNS disease.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:\n\n  * effectively treated non-melanoma skin cancers\n  * effectively treated carcinoma in situ of the cervix\n  * effectively treated ductal carcinoma in situ\n  * other effectively treated malignancy that is considered cured by local treatment\n* Major injuries and\u002For surgery or bone fracture within 28 days of first dose BI 764532, or planned surgical procedures\n* Known leptomeningeal disease or spinal cord compression due to metastatic disease\n* Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed\n* Active infection that requires medical therapy or other clinically significant intervention\n* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 2 weeks prior to study entry (confirmed via polymerase chain reaction (PCR) test or other applicable test as per local requirements) or suspected SARS-CoV-2 infection as per physician assessment, or close contact (within 1 week) with an individual with confirmed SARS-CoV-2 infection\n* Any of the following known laboratory evidence of hepatitis virus infection:\n\n  * Positive results of hepatitis B surface (HBs) antigen\n  * Presence of hepatitis B core (HBc) antibody together with hepatitis B virus DNA (HBV-DNA)\n  * Presence of hepatitis C ribonucleic acid (RNA)\n* Known human immunodeficiency virus (HIV) infection. Further exclusion criteria apply.",{"count":84,"type":21},12,[24],"This study is open to adults with small cell lung cancer and other neuroendocrine cancers. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out how a medicine called BI 764532 gets distributed in the body and in tumours.\n\nParticipants get BI 764532 when starting treatment. In the first weeks, doctors check how BI 764532 is taken up in tumours by means of an imaging method. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.",[88,30],"Small Cell Lung Carcinoma (SCLC)","2026-05-07",{"date":91,"type":42},"2026-05-08",{"date":93,"type":42},"2024-08-06",{"date":95,"type":21},"2026-11-25",{"name":73,"class":74},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":50},"100301589","phase-2-lu-177-dotatate-lutathera-in-therapy-of-inoperable-pheochromocytoma-paraganglioma-100301589","NCT03206060","Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma\u002F Paraganglioma","* INCLUSION CRITERIA:\n* Surgically inoperable participants with clinical diagnosis of PHEO\u002FPGL who also have demonstrated disease histologically consistent with pheochromocytoma or paraganglioma (preferably confirmed by research site pathology review if initial pathology was done outside of research site, but not mandatory)\n* Progressive disease by RECIST 1.1 with or without symptoms within the last 12 months. NOTE: Untreated participants with existing histologic diagnoses are eligible if progression can be demonstrated\n* PHEO\u002FPGL that is not associated with any known susceptibility genetic mutations for PHEO\u002FPGL except SDHx mutation (a.k.a. \"apparent sporadic\"), based on documented genetic testing results obtained prior to study enrollment. PHEO\u002FPGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study.\n* Both metastatic and inoperable primary-only participants are eligible.\n* Must have presence of SSTR+ disease as documented by positive Ga-68-DOTATATE PET scan within 12 weeks of anticipated treatment.\n\nNOTE:\n\n* Positivity of Ga-68-DOTATATE PET scan defined as having at least one lesion that is greater than or equal to 10 mm in diameter with uptake that is higher than or equal to liver and is qualitatively higher and distinguishable from background activity.\n* Measurable disease as defined by RECIST 1.1.\n\n  * Age greater than or equal to 18\n  * Karnofsky Performance Score greater than or equal to 60 or ECOG Performance Status of 2 or better.\n  * Able to understand and willing to sign informed consent.\n  * Ability and willingness to obtain all required scans per study schedule.\n  * Negative serum pregnancy test for women of child-bearing potential. NOTE: A female is not of childbearing potential if a prior history of hysterectomy with bilateral oophorectomy or other procedure has rendered the participant surgically sterile, or \\>2 years since last menstruation.\n  * Female participants of childbearing potential and male participants who are not surgically sterile or with female partners of childbearing potential must agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) prior to study entry, for the duration of study participation, and for 4 months for male participants or 7 months for female participants (10 half-lives of Lu-177) after the last dose of Lu-177-DOTATATE.\n  * Must have outside endocrinologist\u002Fmedical oncologist who can follow the participant after receiving PRRT (NIH only requirement).\n  * Patients with secreting tumors must be receiving adequate pharmacologic catecholamine blockade as determined by the treating physician.\n  * Ineligible, unable to or unwilling to receive standard first line therapy for PHEO\u002FPGL.\n\nEXCLUSION CRITERIA:\n\n* Creatinine clearance \\\u003C50 mL\u002Fmin calculated by the MDRD method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods.\n* Serum albumin less than or equal to 3.0 g\u002FdL unless prothrombin time is within the normal range.\n* Liver dysfunction as evidenced by Child s Class C Liver Disease or worse Alternatively, AST or ALT \\> 2.5 times institutional upper limit of normal (ULN) unless liver metastases are present, in which case up to 5 times ULN would be allowed.\n* Hb \\\u003C 8.0 g\u002FdL; WBC \\\u003C 2.0 x 10\\^9\u002FL (or Absolute Neutrophil Count \\\u003C 1000); Platelets \\\u003C 100 x 10\\^9\u002FL\n* In participants with symptoms of congestive heart failure, New York Heart Association (NYHA) classification of grade III or IV\n* Pregnancy or lactation.\n* Prior anti-tumoral radionuclide therapy with unsealed sources. Prior therapy with sealed radioactive sources such as brachytherapy will be allowed.\n* Prior local radiation therapy would be allowed as long as there is at least one non-irradiated index lesion.\n* Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study. Patients with a history of brain metastases must have a head CT or MRI scan with contrast to document stable disease for at least 24 weeks prior to enrolment in the study.\n* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.\n* Patients who participated in any therapeutic clinical study with an investigational agent within the last 30 days.\n* Patients may be on somatostatin analogue therapy (e.g. but not only limited to sandostatin or lanreotide therapy). However, therapy with somatostatin analogues should not be initiated or altered within 3 months of study enrolment. Patients on short term octreotide may have dose held for 24 hours prior to Lu-177-DOTATATE therapy. Those on long acting octreotide therapy will receive treatment at 1 to 5 days prior to their next cold octreotide dose, in order to prevent competition for the receptor.\n* Patient weight \\> 400 lbs (table limit for PET scanner) or per local institutional standard for participating sites.\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, hypertension (\\>180\u002F110), arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.",{"count":104,"type":21},130,[25],"Background:\n\nPheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help.\n\nObjective:\n\nTo learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return.\n\nEligibility:\n\nAdults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET\u002FCT imaging\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests.\n\nEligible participants will be admitted to the NIH Clinical Center.\n\nParticipants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart.\n\nBetween 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table.\n\nParticipants will have vital signs taken. They will give blood and urine samples.\n\nDuring the study, participants will have other scans taken. Some scans will use a radioactive tracer.\n\nParticipants will complete quality of life questionnaires.\n\nParticipants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.",[108,109,29,30],"Pheochromocytoma","Paraganglioma",[111,112,113,32,114],"Hypertension","Catecholamine","Familial Syndromes","Ionizing Radiation","2026-04-23",{"date":117,"type":42},"2026-04-24",{"date":119,"type":42},"2017-10-10",{"date":121,"type":21},"2033-01-01",{"name":48,"class":49},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":150},"100613893","phase-4-prospective-multicenter-real-world-study-of-surufatinib-in-patients-with-advanced-neuroendocrine-neoplasms-100613893","NCT07272512","Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms","ZSPAC-17","Inclusion Criteria:\n\n* Adequately understand the study and voluntarily sign the Informed Consent Form.\n* Have a confirmed histological or cytological diagnosis of neuroendocrine neoplasm.\n* Have measurable disease based on RECIST 1.1.\n* Have adequate organ and bone marrow function.\n* Life expectancy \\> 12 weeks.\n* Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment.\n\nExclusion Criteria:\n\n* Other malignant tumors diagnosed within 5 years (excluding effectively treated basal cell carcinoma, cutaneous squamous cell carcinoma, or completely resected in situ cervical\u002Fbreast cancer).\n* Concurrent use of other investigational drugs or approved\u002Finvestigational anti-tumor therapies.\n* Contraindications to surufatinib: active bleeding, ulcers, intestinal perforation\u002Fobstruction, uncontrolled hypertension, grade III-IV cardiac insufficiency, \\\u003C30 days post-major surgery, or severe hepatic\u002Frenal impairment.\n* Pregnant (positive pre-treatment pregnancy test) or lactating females.\n* Massive pleural effusion\u002Fascites requiring drainage.\n* Other diseases\u002Fabnormalities (metabolic, physical, or laboratory) deemed by the investigator to preclude study drug use.",{"count":131,"type":21},350,[133],"PHASE4","This is a prospective, multicenter, phase 4, single-arm study designed to evaluate the effectiveness and safety of surufatinib in adult patients with advanced neuroendocrine neoplasms (NENs) treated in routine clinical practice. Approximately 350 patients with histologically or cytologically confirmed advanced NENs and at least one measurable lesion (RECIST 1.1) will receive oral surufatinib, either as monotherapy (300 mg once daily in 4-week cycles) or in combination regimens (250 mg once daily), according to the treating physician's judgment and protocol guidance.\n\nParticipants will be followed with regular imaging, laboratory tests, cardiac assessments, and patient-reported outcome questionnaires to monitor tumor response, side effects, quality of life, and treatment adherence. The primary outcomes include progression-free survival, objective response rate, disease control rate, and overall survival; safety will be assessed by the type, frequency, and severity of adverse events. The findings are expected to inform standardized, evidence-based use of surufatinib and help optimize individualized treatment strategies for patients with advanced NENs in the real-world setting.",[29,30],[137,138,139],"surufatinib","advanced neuroendocrine tumors","advanced neuroendocrine neoplasms","2025-12-18",{"date":142,"type":42},"2025-12-19",{"date":144,"type":42},"2025-11-11",{"date":146,"type":21},"2028-11-29",{"name":148,"class":149},"Shanghai Zhongshan Hospital","OTHER",4,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100557666","collection-of-liquid-biopsy-samples-of-neuroendocrine-neoplasms-nen-patients---collection-of-net-collectnet-20-a-study-by-the-be-force-consortium-100557666","NCT06541080","Collection of Liquid Biopsy Samples of Neuroendocrine Neoplasms (NEN) Patients - Collection of NET (CollectNET) 2.0, a Study by the BE-FORCE Consortium","Collection of Liquid Biopsy Samples of Patients With Neuroendocrine Neoplasms - CollectNET 2.0, a Study by the BE-FORCE Consortium","BE-FORCE","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age on the day of signing informed consent.\n* Written informed consent must be obtained from the patient or patient's legal representative.\n* Patient is willing and able (in the investigator's opinion) to comply with all trial requirements.\n* For inclusion in the Regular Sampling Group: patients must have (had) a histologically confirmed NEN diagnosis, patients must have measurable tumor burden on imaging, patients must be in follow-up in one of the participating hospitals and patients who have progressed or completed follow-up for 3y in the Intensive Sampling Group.\n* For inclusion in the Intensive Sampling Group: patients who are included in the Regular Sampling Group and where either a baseline sample (RSG-B) or a recent RSG follow-up sample (RSG-V…) has been collected before the start of 1st systemic treatment (as defined below), patients must be diagnosed with a histologically confirmed NEN diagnosis of a WHO 2019 grade 1-3 NET or NEC of pancreatic, colorectal, or small intestinal origin and patients must start any kind of 1st line systemic treatment (e.g. somatostatin analogues, targeted therapy, chemotherapy, etc.).\n\nExclusion Criteria:\n\n* Patients who are unable to give informed consent.\n* Patients for which blood sampling would compromise their overall health.\n* Patients pregnant at time of study entry or are willing to become pregnant during the study.\n* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.",{"count":160,"type":21},550,"OBSERVATIONAL","The CollectNET 2.0 by BE-FORCE is a prospective, multicentric, interventional study in which liquid biopsies will be collected from neuroendocrine neoplasms (NEN) patients to create an extensive biobank that will be used for current and future circulating cell-free DNA (ccfDNA) analyses. Two sampling groups will be created: the \"Regular Sampling Group\" and the \"Intensive Sampling Group\". Upon participation, up to four additional blood tubes (max. total of 32.5mL) will be collected at each timepoint as specified below. These include 3 Streck Cell-Free DNA tubes (10 mL each) which will be used for the extraction of ccfDNA and 1 PreAnalytiX (PAXgene)® Blood RNA tube (2.5 mL). All NEN patients in one of the participating hospitals who have measurable tumor burden on imaging will be asked to participate in our study and will be included in the \"Regular Sampling Group\". If additionally, the patient is (i) diagnosed with a histologically confirmed NEN of World Health Organisation (WHO) 2019 grade 1-3 neuroendocrine tumor (NET) or neuroendocrine carcinoma (NEC) from pancreatic, colorectal or small intestinal origin and (ii) is starting any kind of 1st line systemic treatment (e.g. somatostatin analogues, targeted therapy, chemotherapy, etc.), they will be followed up more intensively as per the \"Intensive Sampling Group\". If during follow-up in this \"Intensive Sampling Group\" patients have disease progression or have completed follow-up for 3 years in this group, their follow-up will switch back to the \"Regular Sampling Group\" for the remainder of the study. Ultimately, the samples collected in the \"Intensive Sampling Group\" will be used to achieve the second and third objective of our current project. These are to validate novel ccfDNA analyzing techniques (IMPRESS and GIPXplore) for assessment of the presence and quantification of circular tumor DNA (ctDNA) in liquid biopsies, and to monitor tumor fraction (i.e., ctDNA quantities) over time in sequential plasma samples from NEN patients using ccfDNA assays and correlating this with time to progression (according to RECIST 1.1 criteria) to explore the predictive efficacy of ccfDNA analysis and thereby evaluate its biomarker potential for patient follow-up. While samples from the \"Regular Sampling Group\" and the PAXgene tubes will be biobanked for future projects.",[30],[165,166,167],"liquid biopsy","circulating cell-free DNA","methylation-based biomarkers","2024-08-01",{"date":170,"type":42},"2024-08-07",{"date":172,"type":42},"2022-01-03",{"date":174,"type":21},"2030-12-04",{"name":176,"class":149},"University Hospital, Antwerp",8]