[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-tumor-of-the-lung\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-tumor-of-the-lung":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,78],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":45},"100588444","phase-1-a-study-of-177lu-dtpa-sc1656-in-people-with-neuroendocrine-carcinomas-of-the-lung-and-prostate-100588444",false,"NCT06941480","A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine Carcinomas of the Lung and Prostate","Characterizing the Theranostic Potential of DLL3-targeting Agents in High-grade Neuroendocrine Carcinomas of the Lung and Prostate","Inclusion Criteria:\n\n* Subjects with histologically proven progressive metastatic high-grade neuroendocrine carcinomas of the lung (small-cell lung cancer) and prostate (neuroendocrine prostate cancer) that has relapsed following at least 1 line of standard chemotherapy i. Prostate cancer patients will be defined by either of the following criteria: ii. The presence of chromogranin staining on tissue iii. At least two of the pathogenic mutations of PTEN, RB1, or p53 iv. Disease exclusively involving the viscera v. Disease in which the PSA is \\\u003C10 but the number of bone lesions is \\>20 vi. Histologic evidence of small cell carcinoma or other stains consistent with neuroendocrine disease (on the primary disease or metastases) vii. DLL3 positivity on previously available tissue specimens\n* Ability to understand and willingness to sign a written informed consent document\n* Aged 18 years or older at the time of signing consent\n* Progression of disease defined by one of the following occurring within 3 months of study entry:\n\n  i. At least a 20% increase in radiologically or clinically measurable disease; ii. Appearance of any new lesion; iii. For prostate cancer patients progression criteria will be per PCWG3: iv. Either v. A rising PSA over a sequence of at least 1-week intervals OR i. An increase in soft tissue disease to qualify for disease progression by RECIST 1.1 OR ii. Two new bone lesions by bone scintigraphy\n\nPatients with metastatic disease by virtue of disease exclusively evident by PSMA PET will not be eligible. All patients must have metastatic disease by evidence of standard scintigraphic or anatomic imaging in accord with PCWG3\n\n* At least one tumor lesion on CT or MR ≥ 2 cm\n* ECOG performance status 0 to 2\n* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.\n* Previous chemotherapy, immunotherapy, and\u002For investigational agents are allowed if completed ≥4 weeks prior to study entry. For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.\n* Preserved hematological function:\n\n  i. Hb ≥9.0 g\u002FdL; ii. WBC ≥3000\u002Fmm3; iii. ANC≥1500\u002Fmm3; iv. Platelets ≥75.000\u002Fmm3\n* Preserved renal function:\n\n  i. Serum creatinine ≤1.7 mg\u002FdL ii. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73m2\n* Preserved hepatic function:\n\n  i. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN) or ≤ 5 x ULN if liver metastases are present ii. bilirubin ≤ 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis)\n* Willingness to undergo baseline and follow up biopsy to obtain tissue for DLL3 IHC and genomic analyses\n* In order to proceed with the treatment with 177Lu-DTPA-SC16.56, patients must exhibit overexpression of DLL3, as SUVmax greater than in normal liver, in ≥80% of tumor lesions among the growing progressing lesions that are ≥2cm.\n\nExclusion Criteria:\n\n* History of anaphylactic reaction to humanized or human antibodies\n* History of severe allergic reaction to X-ray contrast medium despite premedication\n* Prior treatment with Rova-T (rovalpituzumab)\n* Women who are pregnant or unwilling to discontinue breastfeeding\n* Spinal cord compression or symptomatic\u002Funcontrolled epidural disease, unless treated and stable for at least 1 week prior to enrolment.\n* Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 4 months for males and 7 months for females after receiving the therapeutic study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation\u002Focclusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women)\n* Life expectancy \\\u003C 6 months as assessed by the treating physician.\n* Unresolved toxicities from prior antitumor therapy, defined per Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, to to grade 1 or grade 0 or to levels dictated in the inclusion criteria.\n* Major surgery within 28 days of enrolment with the exception of biopsy and insertion of central venous catheter.\n* Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Known parenchymal brain metastases and\u002For carcinomatous meningitis, unless these metastases have been treated and stabilized.\n* Unmanageable urinary incontinence rendering the administration of 177Lu-DTPA-SC16.56 unsafe (e.g., urinary catheterization not feasible).\n* Other ongoing invasive malignances (i.e., not carcinomas in situ, non-mm invasive urothelial cancer, or other non-invasive tumors), and prior cancers that have been treated that have a \\>30% likelihood of relapse within the next two years.\n* Subjects likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the subject's and investigator's knowledge.\n* Prostate cancer patients with mixed histologies (i.e., neuroendocrine and adenocarcinomas) are eligible provided that they meet all of the above eligibility criteria.\n* Patients for whom their clinicians believe would benefit by continuing their treatments for their disease to control any adenocarcinoma (such as ADT or other AR axis directed therapy) can and should remain on those treatments while on this protocol, if their clinician believes that it would be clinically beneficial to do so.\n* Concurrent chemotherapy, other radiopharmaceuticals of any type, and immunotherapy are excluded\n* Complementary approaches known to modulate PSA should not be taken while on this trial","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to find out whether 177Lu-DTPA-SC16.56 is a safe treatment for people with small-cell lung cancer or neuroendocrine prostate cancer",[26,27,28,29],"Neuroendocrine Tumor of the Lung","Neuroendocrine Carcinoma of Lung","Neuroendocrine Carcinoma","Neuroendocrine Carcinoma of Prostate",[26,27,28,29,31,32,33],"177Lu-DTPA-SC16.56","Memorial Sloan Kettering Cancer Center","24-330","NOT_YET_RECRUITING","2026-04-13",{"date":37,"type":38},"2026-04-14","ACTUAL",{"date":40,"type":20},"2026-06",{"date":42,"type":20},"2030-05",{"name":32,"class":44},"OTHER",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100482106","early-phase-1-a-safety-study-of-212pb-pentixather-radioligand-therapy-100482106","NCT05557708","A Safety Study of 212Pb-Pentixather Radioligand Therapy","Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)","Inclusion Criteria:\n\n* ability to provide independent consent\n* adequate bone marrow function (platelet count ≥ 100,000; hemoglobin of ≥ 10 g\u002FdL; neutrophil count ≥ 1,500 cells\u002Fmm3)\n* adequate kidney function (creatinine clearance of ≥ 50 mL\u002Fmin using the Cockcroft-Gault equation\n* adequate liver function (serum bilirubin ≤ 3x the upper limit of normal, AST ≤ 5x the upper limit of normal, and ALT ≤ 5x the upper limit of normal)\n* failed initial therapy or declined further therapy known to confer benefit\n* have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pentixather SPECT\u002FCT\n\nExclusion Criteria:\n\n* major surgery within 4 weeks of consent\n* antoher investigational agent within 4 weeks of consent\n* uncontrolled illness including, but not limited to, ongoing or active infection that would necessitate a delay in therapy or cause a hospital admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic cirrhosis or severe impairment, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* prior solid organ transplant\n* cytotoxic or antineoplastic therapy within 21 days of consent (42 days for nitrosoureas)\n* antibody therapy within the 21 days of consent\n* allogenic bone marrow or stem cell transplant, or any stem cell infusion, within 84 days of consent\n* pregnancy\n* breastfeeding\n* refusal to comply with birth control requirements during study",{"count":54,"type":20},20,[56],"EARLY_PHASE1","This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients who have been diagnosed with, and previously treated, for atypical carcinoid lesions of the lung.",[59,26,60],"Carcinoid Tumor Lung","Carcinoma, Small-Cell Lung",[62,63,64,65,66,67],"radioligand therapy","pentixather","Lead 203","Lead 212","alpha therapy","dosimetry","2025-07-02",{"date":70,"type":38},"2025-07-08",{"date":72,"type":20},"2026-07-01",{"date":74,"type":20},"2030-06-30",{"name":76,"class":44},"Yusuf Menda",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100552384","phase-2-everolimus-5-mg-vs-10-mgdaily-for-patients-with-neuroendocrine-tumors-100552384","NCT06472388","Everolimus 5 mg vs 10 mg\u002FDaily for Patients With Neuroendocrine Tumors","Randomized Phase II Trial of Everolimus 5 mg vs 10 mg\u002FDaily for Patients With Advanced Neuroendocrine Tumors","EVENET","Inclusion Criteria:\n\n* Histological confirmation of well-differentiated Grade 1\u002FGrade 2 NET from gastrointestinal, pancreatic, pulmonary or unknown primary sites.\n* Metastatic or locally advanced and unresectable disease, measurable by images\n* Disease progression by RECIST 1.1 in the last 6 months assessed by local investigators\n* At least one previous line of systemic treatment (suspended for more than 3 weeks).\n* Eastern Cooperative Oncology Group (ECOG) 0-2 o Good organ function:\n\n  * Hemoglobin \\> 8 g\u002FdL\n  * Neutrophils ≥ 1,500\u002Fmm³\n  * Platelets \\> 90,000\u002Fmm³\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN \\[upper limit of normal\\] or ≤ 5 x ULN for patients with liver metastases\n  * Bilirubin ≤ 1.5 x ULN, creatinine \\\u003C 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Aggressive disease requiring cytotoxic therapy\n* Severe\u002Funcontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.\n* MiNEN","16 Years",{"count":88,"type":20},100,[90],"PHASE2","Everolimus is approved in many countries to treat patients with advanced\u002Fmetastatic well-differentiated neuroendocrine tumors (NET), providing median progression-free survival times of approximately 12 months across different types of NET. However, it is can cause severe adverse effects. Phase I trial demonstrated that a dose of 5mg\u002Fday\u002Fweek was sufficient to inhibit cell proliferation by blocking the mTOR pathway.\n\nThis is a randomized, open-label, phase II near-equivalence clinical trial of oral everolimus 5 mg vs 10 mg oral\u002Fdaily and continuously in patients with Grade 1 or Grade 2 metastatic NET, with tumor progression or intolerance to at least one line of treatment and with radiological disease progression within 6 months.",[93,94,95,96,97,26,98],"Neuroendocrine Tumors","Progression","Neuroendocrine Tumor Grade 1","Neuroendocrine Tumor Grade 2","Neuroendocrine Tumor of Pancreas","Neuroendocrine Tumor Carcinoid","RECRUITING","2024-06-18",{"date":102,"type":38},"2024-06-25",{"date":104,"type":38},"2024-04-24",{"date":106,"type":20},"2026-12-31",{"name":108,"class":44},"AC Camargo Cancer Center",2]