[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,51,64,90,114,135,163,193,215,233,267,289,324,351,381,413,431,451],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053992","phase-2-a-ugt1a1-genotype-directed-study-of-belinostat-pharmacokinetics-and-toxicity-100053992",false,"NCT06406465","A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity","-INCLUSION CRITERIA:\n\n1. Participants must have histologically confirmed diagnosis of Extrapulmonary High-Grade Neuroendocrine Neoplasms (HGNENs) for which there is no known standard therapy capable of extending life expectancy.\n2. Age \\>= 18 years.\n3. Participants with neuroendocrine prostate cancer may continue ongoing LHRH agonist therapy.\n4. Participants with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment while on study.\n5. Evaluable (measurable or non-measurable) disease, per RECIST 1.1.\n6. ECOG performance status \\\u003C=2 at screening\n7. Participants must have adequate organ and marrow function as defined below:\n\n   * Leukocytes \\>=3,000\u002FmcL\n   * Hemoglobin \\>= 10 g\u002FdL\n   * Absolute neutrophil count (ANC) \\>=1,500\u002FmcL\n   * Platelets \\>=100,000\u002FmcL\n   * Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transaminase (SGOT) \u002F Alanine aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT): \\\u003C=3 X institutional upper limit of normal\n   * Total bilirubin \\\u003C= 1.5 x institutional upper limit of normal (ULN).\n\n   NOTE: In participants with Gilbert s syndrome, a total bilirubin \\\u003C= 3.0 X ULN is allowed\n   * Serum Creatinine \\\u003C= 1.5 X institutional ULN OR\n   * An estimated Creatinine clearance (CrCL) \\>=60 mL\u002Fmin\u002F1.73 m\\^2 based on the Cockcroft Gault equation\n   * Prothrombin time (PT) \u002F International normalized ratio (INR) and Partial thromboplastin time (PTT) \\\u003C= 1 X institutional ULN\n8. Hepatitis B virus (HBV)-infected participants can be enrolled if HBV DNA is undetectable. Hepatitis C virus (HCV)-infected participants can be enrolled if HCV RNA level is undetectable\n9. Women of child-bearing potential (WOCBP) must agree to use effective contraception (hormonal, intrauterine device (IUD), tube ligation, a partner has had a previous vasectomy, abstinence) prior to study entry, during the study, and for 14 months for women after the last dose of the study drug(s). Men with partners of childbearing potential must agree to use effective contraception (abstinence, condoms, previous vasectomy) or request partners to use effective contraception (per above) during the study and for 11 months after the last dose of study therapy.\n10. Breastfeeding participants must be willing to discontinue breastfeeding starting with prior to study entry, during the study, and for 3 months after the last dose of the study drug(s).\n11. Willing to comply with study procedures and follow-up.\n12. Participants must be able to understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Participants with prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 14 days prior to the first drug administration. Additionally, FDA-approved hormonal therapy for the treatment or prevention of other malignancies (e.g., breast cancer, prostate cancer) may be continued where in the opinion of the investigator stopping such therapies may increase the risk of disease progression. Potential drug-drug interactions with the hormonal agent will be assessed by the investigator prior to enrollment.\n2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to belinostat, cisplatin, etoposide or other agents used in study. Participants with a history of allergic reactions to medications containing polysorbate 80 will be evaluated on a case-by-case basis.\n3. Participants with treated brain metastases are not eligible except if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n4. Participants who have not recovered (CTCAE \\\u003C= grade 1) from non heme adverse events due to prior treatments, except for alopecia, or stable grade 2 tinnitus (not interfering with ADL's) or baseline hearing loss by audiometry or stable grade 2 sensory neuropathy (moderate symptoms; limiting instrumental ADL) without pain or motor component, and not interfering with ADL's.\n5. Participants taking strong UGT1A1 inhibitors or CYP3A4 inhibitors or inducers must discontinue their use a minimum of 5 half-lives prior to starting treatment on this trial\n6. Participants with platinum-refractory disease.\n7. Participants who have had another histone deacetylase inhibitor (e.g., valproic acid, vorinostat) for at least 2 weeks prior to enrollment.\n8. Participants who have had radiation to the pelvis or other bone marrow-bearing sites will be considered on a case-by-case basis and may be excluded if the bone marrow reserve is not considered adequate (\\>25% of bone marrow).\n9. Pregnancy (confirmed with beta-Human chorionic gonadotropin (HCG) serum or urine pregnancy test performed in WOCBP at screening)\n10. Significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease), myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia, or a need for anti-arrhythmic therapy (use of medication to control heart rate in participants with atrial fibrillation is allowed, if stable medication for at least last month prior to enrollment and medication not listed as causing Torsade de Points), or evidence of acute ischemia on ECG.\n11. Baseline prolongation of QT\u002FQTc interval, i.e., defined as an average QTc interval \\> 450 msec calculated using the Fridericia formula for QT correction; Long QT Syndrome; or the required use of concomitant medication that may cause Torsade de Pointes.\n12. Participants with HIV infection if CD4 count \\\u003C200 cells per cubic millimeter before treatment initiation\n13. Uncontrolled intercurrent illness that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nHigh-grade neuroendocrine carcinomas (HGNEC) are cancers that develop in different parts of the body, including the digestive tract, genitals, neck, and head. One drug (belinostat), combined with 2 other drugs (etoposide and cisplatin), is approved to treat HGNEC. But some people may have a gene variant that affects how quickly their body gets rid of the drug; these people may do better with different dosages of belinostat.\n\nObjective:\n\nTo test higher or lower doses of belinostat based on gene variants in people with HGNEC.\n\nEligibility:\n\nPeople aged 18 years and older with HGNEC.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Some blood will be used for genetic testing. They will have imaging scans and a test of their heart function. Samples of tumor tissue may be collected.\n\nAll 3 study drugs (belinostat, etoposide, cisplatin) are given through a tube attached to a needle inserted into a vein. Treatment will be given in 21-day cycles.\n\nFor cycles 1 through 6: Participants will come to the clinic for the first 4 days. They will be given all 3 drugs. Imaging scans and other tests will be repeated. Each visit will last 4 to 8 hours.\n\nAfter cycle 6: Participants may continue treatment with belinostat alone. They will come to the clinic for the first 3 days of each cycle. They may continue treatment for up to 5 years if the drug is helping them.\n\nParticipants will have a follow-up visit 30 days after their last dose of belinostat. Then they will receive follow-up visits by phone or email every 3 to 6 months.",[26,27,28,29,30],"Carcinoma, Neuroendocrine","Tumor, Neuroendocrine","Tumors, Neuroendocrine","Neuroendocrine; Carcinoma","Small Cell; Receptors",[32,33,34,35,36,37],"High-grade carcinomas","Resemble small cell carcinoma","Large cell NEC","Histone Deacetylase","Genotypes","Neuroendocrine malignancies","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":20},"2026-07-16",{"date":46,"type":20},"2028-07-30",{"name":48,"class":49},"National Cancer Institute (NCI)","NIH",1,{"id":52,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":24,"conditions":55,"keywords":56,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":50},"100547322",{"count":19,"type":20},[23],[26,27,28,29,30],[32,33,34,35,36,37],"2026-07-01",{"date":59,"type":42},"2026-07-02",{"date":61,"type":20},"2026-07-07",{"date":46,"type":20},{"name":48,"class":49},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":50},"100637564","phase-3-a-study-of-zg006-for-injection-versus-investigator-selected-chemotherapy-in-participants-with-advanced-neuroendocrine-carcinoma-100637564","NCT07595913","A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma","A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma","Inclusion Criteria:\n\n* Has provided written informed consent voluntarily after being fully informed about the study.\n* Male or female, aged 18 to 75 years (inclusive) at the time of informed consent signing.\n* Histologically or cytologically confirmed advanced neuroendocrine carcinoma (NEC); small cell lung cancer (SCLC) and combined SCLC are excluded. Additionally, the Participants with DLL3-positive NEC who have received prior systemic therapy (second-line and above)..\n\nExclusion Criteria:\n\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.","75 Years",{"count":73,"type":20},240,[75],"PHASE3","This Phase III, multicenter, randomized, open-label, controlled study is designed to assess the efficacy and safety of ZG006 versus investigator-selected chemotherapy in participants with DLL3-positive advanced neuroendocrine carcinoma who have received prior systemic therapy.",[78],"Neuroendocrine Carcinoma","NOT_YET_RECRUITING","2026-05-13",{"date":82,"type":42},"2026-05-19",{"date":84,"type":20},"2026-07",{"date":86,"type":20},"2028-12",{"name":88,"class":89},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":50},"100584450","phase-1-svv-001-with-nivolumab-and-ipilimumab-in-patients-with-poorly-differentiated-neuroendocrine-carcinomas-nec-or-well-differentiated-high-grade-neuroendocrine-tumors-net-100584450","NCT06889493","SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)","A Phase 1 Trial of the Oncolytic Virus SVV-001 in Combination With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas or Well-Differentiated High-Grade (Grade 3) Neuroendocrine Tumors","Inclusion Criteria:\n\n1. Male or female patients, 18 years of age or older at the time of consent.\n2. Life expectancy of 6 months or greater as assessed by the treating oncologist.\n3. Have advanced metastatic disease that has progressed on at least one line of available therapy.\n4. Histologically or cytologically confirmed diagnosis of Grade 3 well-differentiated neuroendocrine tumor (NET) or poorly differentiated neuroendocrine carcinoma (NEC; large-cell neuroendocrine carcinoma, small-cell carcinoma, mixed neuroendocrine non neuroendocrine carcinoma). Note: if an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening for diagnostic confirmation, at the Principal Investigator's (PI's) discretion, a screening biopsy will be ordered.\n5. For patients in Part 1A, in addition to histological or cytological confirmation of NEC or NET (see Inclusion #4), radiological confirmation of tumor is required.\n6. Parts 1B and 2 only: Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or immune-related Response Evaluation Criteria in Solid Tumors (iRECIST). At least one lesion must be suitable for multiple injections (up to 6 injections every 2 weeks) with SVV-001. Lesions for injection must be ≥10 mm in longest diameter and deemed safe and suitable for injection by the Investigator.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Recovered to Grade 1 or baseline from any clinically significant toxicity associated with prior treatments (excluding alopecia) prior to initiation of investigational medicinal product (IMP) administration.\n9. Adequate hematological, renal, and liver function defined as follows:\n\n   * a. Hepatic:\n\n     * i. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) (≤5 × ULN if liver metastases are present)\n     * ii. Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)\n   * b. Renal:\n\n     * i. Creatinine clearance ≥50 mL\u002Fminute using Cockcroft Gault equation\n   * c. Hematologic:\n\n     * i. Absolute neutrophil count ≥1500 cells\u002FµL\n     * ii. Platelet count ≥100,000 platelets\u002FµL\n     * iii. Hemoglobin ≥9.0 g\u002FdL\n     * iv. International normalization ratio (INR) within the institutional normal range\n     * v. Normal prothrombin time (PT) and partial thromboplastin time (PTT)\n10. For Part 2 Expansion Cohort patients only, patients will submit archival tissue at Screening and undergo a post-treatment biopsy according to the treating institution's guidelines with the following exceptions:\n\n    * a. If an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening, at the PI's discretion, a screening biopsy will be ordered.\n    * b. Participants will not undergo a biopsy procedure for collection of the post-treatment biopsy if, in the discretion of their treating physician, the participant's condition has deteriorated to the point where performance of a biopsy procedure would place the participant at an increased risk for complications beyond what is reasonably expected for a biopsy collected as part of the participant's standard medical care.\n11. Women of childbearing potential must agree to use a reliable form of contraceptive during the trial treatment period and for at least 7 months following the last dose of IMP.\n12. Male patients must agree to use an adequate method of contraception during the trial treatment period and for at least 7 months following the last dose of IMP.\n13. Patient is willing and able to comply with all protocol-required assessments, visits, and procedures.\n14. Provide written informed consent prior to performing any trial-related procedure.\n\nExclusion Criteria:\n\n1. Any active second malignancy within the 2 years prior to the screening visit, unless the patient has undergone curative surgery for the tumors such as in situ cervical cancer or squamous cell cancer of the skin.\n2. Has had cytotoxic chemotherapy or radiation therapy within 3 weeks; and less than 5 half-lives or 6 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of SVV-001.\n3. Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of SVV-001.\n4. Has any physical abnormality of the tissue\u002Forgan to be biopsied that would put the patient at increased risk of bleeding secondary to the injection and\u002For biopsy.\n5. Has received a live-virus immunization within 30 days prior to the screening visit or anticipates receiving a live virus immunization during the trial or within 30 days of the last treatment with IMP.\n6. Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or other immunosuppressive medications. Local steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or equivalent would not result in exclusion from the trial.\n7. Presence of primary immunodeficiency or receiving systemic steroids of \\>10 mg\u002Fday prednisone or equivalent or other immunosuppressive agents within 14 days prior to the first dose of SVV-001.\n8. Any active infection, including known infection with human immunodeficiency virus (HIV), active hepatitis, or seropositive for hepatis B immunoglobulin (Ig) M core antibody or hepatitis C ribonucleic acid (RNA) at the screening visit.\n9. Patients with a history of solid-organ or bone marrow transplant.\n10. Known hypersensitivity to ipilimumab or nivolumab or their excipients\n11. Has known untreated central nervous system metastases. Patients with treated brain metastases are eligible as long as they are stable and there is no evidence of progression for at least 4 weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging (MRI) or computed tomography (CT)) during the screening period.\n12. Any clinically significant (i.e., active) cardiovascular disease, including cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n13. Patients with an ejection fraction (EF) \\\u003C 50 on a 2D echocardiogram (ECHO).\n14. Patients whose baseline pulse oximetry (saturation of peripheral oxygen (SpO2)) is \\\u003C 92% on Room air.\n15. Any chronic illness, psychiatric condition, or social situation that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance or would place the patient at an unacceptable risk and\u002For have the potential to affect interpretation of the results of the trial.\n16. Female participants who are breastfeeding and\u002For who have a positive pregnancy test result prior to receiving any treatment with IMP.\n17. Patients with impaired decision-making capacity.",{"count":98,"type":20},36,[100],"PHASE1","The purpose of this study is to determine:\n\n1. The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.\n2. The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.\n3. The highest dose and frequency of dosing of the trial intervention that targets neuroendocrine tumors with at least the same degree of effectiveness and tolerability as currently available (standard of care) treatments for patients with neuroendocrine tumors.",[78,103],"Neuroendocrine Tumors","2026-04-27",{"date":106,"type":42},"2026-04-28",{"date":108,"type":42},"2025-05-19",{"date":110,"type":20},"2030-06-01",{"name":112,"class":113},"Peter Hosein, MD","OTHER",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":15,"minAge":120,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":132,"locationsCount":134},"100261924","the-molecular-screening-study-for-the-umbrella-trial-sukses-in-relapsed-small-cell-lung-cancer-patients-sukses-s-100261924","NCT02688894","The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]","Inclusion Criteria:\n\n1. Provision of fully informed consent prior to any study specific procedures.\n2. Patients must be ≥20 years of age.\n3. Histologically or cytologically confirmed Small cell lung cancers\n4. ECOG performance status of 0 to 2\n5. Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment\n6. Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis\n\nExclusion Criteria:\n\n1. More than two prior chemotherapy regimen for the treatment of small cell lung cancer\n2. Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method)\n3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤2 years.","20 Years",{"count":122,"type":20},797,"OBSERVATIONAL","This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.\n\nThis procedure can be performed during or after the first-line treatment. DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and\u002For blood.\n\nImmunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.\n\nTumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and\u002For FISH.\n\nSpecific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.",[126,78],"Small Cell Lung Cancers","2026-04-23",{"date":106,"type":42},{"date":130,"type":42},"2016-04-29",{"date":86,"type":20},{"name":133,"class":113},"Samsung Medical Center",6,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":150,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100588444","phase-1-a-study-of-177lu-dtpa-sc1656-in-people-with-neuroendocrine-carcinomas-of-the-lung-and-prostate-100588444","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",{"count":143,"type":20},12,[100],"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",[147,148,78,149],"Neuroendocrine Tumor of the Lung","Neuroendocrine Carcinoma of Lung","Neuroendocrine Carcinoma of Prostate",[147,148,78,149,151,152,153],"177Lu-DTPA-SC16.56","Memorial Sloan Kettering Cancer Center","24-330","2026-04-13",{"date":156,"type":42},"2026-04-14",{"date":158,"type":20},"2026-06",{"date":160,"type":20},"2030-05",{"name":152,"class":113},7,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100588170","phase-3-tarlatamab-vs-standard-of-care-chemotherapy-in-patients-with-pre-treated-advanced-pulmonary-or-gastroenteropancreatic-poorly-differentiated-neuroendocrine-carcinomas-necs-100588170","NCT06937905","Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)","A GCO Trial Exploring the Efficacy and Safety of Tarlatamab Versus Investigator-choice Chemotherapy in Pre-treated Patients With Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)","TARLANEC","Inclusion Criteria:\n\n1. Signed Informed consent:\n\n   * Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.\n   * Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing\n2. Age ≥ 18 years.\n3. WHO Performance status 0 - 1.\n4. Life expectancy \\> 12 weeks.\n5. Histologically proven and centrally confirmed poorly differentiated neuroendocrine carcinoma (NEC): large cells for lung NEC (WHO 2015 classification), and large and small cells for extra-gastroenteropancreatic (assessed on archived tissue, with possible pre-screening during first-line).\n6. Expression of DLL3 in at least 1% of tumor cells (assessed on archived tissue, with possible pre-screening during first-line)\n7. Tumor progression following one platinum based line of therapy.\n8. Unresectable locally advanced or metastatic stage.\n9. At least one measurable target lesion according to RECIST v1.1 per investigator assessment. The radiological assessment has to be done within the timelines indicated.\n10. Adequate organ function: creatinine clearance \\> 50 mL\u002Fmin, Neutrophils count ≥ 1500\u002Fmm3; Platelets \\> 100 000\u002Fmm3 ; Hemoglobin \\> 9 g\u002FdL; AST and ALT \\\u003C 3 x ULN (upper limit of normal) with total bilirubin ≤ 2 × ULN except subjects with documented Gilbert's syndrome or liver metastasis, who must have AST and ALT ≤ 5 x ULN and a baseline total bilirubin ≤ 3.0 mg\u002FdL.\n11. Full recovery from all toxicities associated with prior treatment, to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia or vitiligo.\n12. Availability of tumor material for central review processes and translational research projects.\n13. Absence of any unstable systemic disease and any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.\n14. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 7 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. They must also refrain from egg cell donation for 7 months after the final dose of investigational product.\n15. Men who are sexually active with women of childbearing potential will be instructed to adhere to contraception for a period of 6 months after the last dose of treatment.\n16. Patient covered by a national health insurance.\n\nExclusion Criteria:\n\n1. Well-differentiated neuroendocrine tumor (NET G1, G2 and G3 according to digestive WHO 2017 classification or typical\u002Fatypical carcinoid tumor according to lung WHO 2015 classification)\n2. Previous treatment targeting DLL3\n3. More than one line of systemic therapy in the metastatic setting. Chemotherapy for non-metastatic stage is not considered as first-line if there is a time interval of at least 6 months between the last dose of chemotherapy for non-metastatic stage and the initiation of first-line chemotherapy for metastatic\u002Frecurrent disease.\n4. Small cell lung NEC (except as a minor \\\u003C30% component in mixed tumors)\n5. Known EGFR activating mutation or ALK or ROS1 rearrangement for lung NEC\n6. Untreated or symptomatic central nervous system (CNS) metastases:\n\n   * Subjects with asymptomatic CNS metastases are eligible if clinically stable for at least 4 weeks and do not require intervention (including use of corticosteroids).\n   * Subjects with treated brain metastases are eligible provided the following criteria are met:\n\n     * Subject is asymptomatic from brain metastases\n     * Whole brain radiation or surgery was completed at least 2 weeks prior to first dose of study treatment (stereotactic radiosurgery completed at least 7 days prior to first dose of study treatment)\n     * Any CNS disease is clinically stable, subject is off steroids for CNS disease for at least 5 days (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs at least 14 days prior to first dose of study treatment\n7. Leptomeningeal metastasis\n8. Patients with a recent history of other malignancies except adequately treated non-melanoma skin cancer, and curatively treated in-situ cancer. Patients with history of solid tumors, including adenocarcinoma, treated in a curative way with or without chemotherapy and without any evidence of disease \\>2 years before randomisation can be included as well.\n9. Major surgery within 28 days prior to initiation of study treatment.\n10. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Head Association class \\> class II) within 12 months prior to initiation of study treatment.\n11. History of arterial thrombosis (e.g. stroke or transient ischemic attack) within 12 months prior to initiation of study treatment.\n12. Symptoms and\u002For clinical and\u002For radiological signs suggestive of uncontrolled and\u002For acute active systemic infection within 7 days prior to first administration ofstudy treatment. Patient with active infection requiring parenteral antibiotic therapy. Upon completion of parental antibiotic therapy and resolution of symptoms, the patient may be considered eligible under the infection criterion.\n13. Known sensitivity and\u002For immediate hypersensitivity to any component of study treatment.\n14. History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.\n15. Patients with immune pneumonitis, pituitary or thyroid disorders, or pancreatitis under treatment with immuno-oncology agents.\n16. Patients reporting infusion-related reactions or severe, life-threatening or recurrent immune-mediated adverse events (grade 2 or higher), including events leading to permanent discontinuation of immuno-oncology agents.\n17. Presence of an indwelling line or drain (including the following: percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, peritoneal drain or catheter, pericardial drain or catheter, drain catheter or thoracic drain for pleural fluid collection).\n18. Patient with a diagnosis of immunodeficiency or undergoing systemic corticotherapy or any other form of immunosuppressive therapy within 7 days prior to administration of the first dose of study treatment.\n19. Known acute or chronic B or C hepatitis by serological evaluation. Patients with serological sequellae of hepatitis (antibodies test serologically positive for virus) without hepatitis could be included.\n20. Known Human immunodeficiency virus infection\n21. Patients who are pregnant or breast-feeding, or planning to become pregnant or breast-feed during the trial and within 7 months after the last dose of study treatment.\n22. Male not wishing to abstain from sperm donation during the trial and within 6 months of the last study treatment.\n23. Vaccination with live or attenuated virus vaccines is not permitted during the 28 days prior to administration of the first dose of treatment, and for the duration of the study. Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) should be avoided during selection, at least 14 days before the first day of treatment. Live, non-replicating smallpox vaccines (such as Jynneos) against monkeypox infection are permitted during the study (except during cycle 1) in accordance with the center's standard of care and internal recommendations.\n24. Active autoimmune disease requiring systemic therapy (except replacement therapy) within the last 2 years or any other disease requiring immunosuppressive therapy during the study.\n25. Patients with other concurrent severe and\u002For uncontrolled medical disease which could compromise participation in the study.",{"count":172,"type":20},129,[75],"Based on the efficacy of tarlatamab in patients with small-cell lung cancer, we aim to assess the efficacy of tarlatamab in patients with Advanced, pulmonary (large-cell only) or gastroenteropancreatic neuroendocrine carcinoma.",[78],[177,178,179,180,181,182],"Neuroendocrine Carcinoma of Lung (Large cells)","Gastroenteropancreatic Neuroendocrine Carcinoma","IFCT","FFCD","GERCOR","GCO","2026-02-09",{"date":185,"type":42},"2026-02-11",{"date":187,"type":42},"2026-02-06",{"date":189,"type":20},"2030-08-01",{"name":191,"class":113},"Intergroupe Francophone de Cancerologie Thoracique",40,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":50},"100595872","phase-1-zg006-and-zg005-in-participants-with-small-cell-lung-cancer-or-neuroendocrine-carcinoma-100595872","NCT07038096","ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","A Phase Ib\u002FII Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age.\n* Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.\n* Eastern Cooperative Oncology Group (ECOG) 0 to 1.\n* Life expectancy \\> 3 months.\n\nExclusion Criteria:\n\n* The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.","70 Years",{"count":202,"type":20},350,[100,23],"This study is a randomized, multicenter, Phase Ib\u002FII clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.",[206,78],"Small Cell Lung Cancer","2025-12-30",{"date":209,"type":42},"2026-01-05",{"date":211,"type":42},"2025-09-23",{"date":213,"type":20},"2027-09",{"name":88,"class":89},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":50},"100514422","phase-1-study-of-zg006-in-participants-with-small-cell-lung-cancer-or-neuroendocrine-carcinoma-100514422","NCT05978284","Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","A Phase 1\u002F2 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years of age;\n* Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), who had no standard treatment available, or were intolerant to standard treatments;\n* Archival tissue sample or fresh biopsy tissue sample must be available for DLL3 detection;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months;\n* Must have evaluable or measurable lesion. For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered evaluable or measurable lesions;\n* All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1, except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc.;\n* Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients having received any of the following treatments:\n\nAnti-DLL3 and anti-CD3 drugs (including investigational drugs); Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry; Systemic immunosuppressive medications, such as corticosteroid (doses \\> 10 mg\u002Fday prednisone or equivalent dose) within 14 days prior to the study entry; Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;\n\n* Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry.\n* The main organ function meets any of the following criteria within 7 days prior to study entry; Hematological function: ANC \\\u003C 1.5×10\\^9\u002FL, PLT \\\u003C 75×10\\^9\u002FL, Hemoglobin (Hb) \\\u003C 100 g\u002FL; Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN, ALT and AST ≥ 5×ULN for liver metastases patients; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin \\\u003C 30g\u002FL; Creatinine clearance (Cockcroft-Gault formula) \\\u003C 50 mL\u002Fmin; INR \\> 1.5 or APTT \\> 1.5×ULN;\n* Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of central nervous system (CNS) metastases; Note: Not applicable to the following conditions: subjects with stable CNS metastases;\n* Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;\n* Any other malignancy within 5 years (other than radically removed and has not recurred tumors including basal cell skin carcinoma, squamous cell skin carcinoma, superficial bladder cancer, localized prostate cancer, cervical cancer and other cancer in situ, etc.);\n* Severe cardiac-cerebral vascular disease, including but not limited to:\n\nAcute myocardial infarction, unstable angina, stroke, or received coronary angioplasty or stent implantation within 6 months before study entry; New York Heart Association functional class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50% or the lower limit of normal; Uncontrollable hypertension (even though the best treatment is used but systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg).\n\nQTc (F) interval prolonged in electrocardiography during the screening baseline period (\\> 480 ms)\n\n* History of autoimmune disease, including but not limited to systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis (except for the following: type I diabetes mellitus, skin diseases that do not require systemic treatment (such as vitiligo), controllable celiac disease, and childhood asthma that completely resolved in adulthood without intervention);\n* Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B\u002FC, active syphilis, or active human immunodeficiency virus infection). Active hepatitis B is defined as: hepatitis B virus DNA titer \\> 10000 copies\u002FmL or 2000 IU\u002FmL; active hepatitis C is defined as: a positive hepatitis C antibody and HCV viral load above the limit of quantification; active human immunodeficiency virus infection is defined as: antibody positive;\n* Active neurologic paraneoplastic syndrome;\n* Interstitial lung disease or non-infectious pneumonitis (other than radiation-induced pneumonia);\n* Having received prior allogeneic stem cell transplantation or solid organ transplantation;\n* Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;\n* Known history of diagnosed neurological or mental disorders, for example, epilepsy, dementia, etc.;\n* A female who is pregnant or nursing;\n* Patients were deemed unsuitable for participating in the study by the investigator for any reason.",{"count":223,"type":20},54,[100,23],"This is a multi-center, open-label, Phase Ⅰ\u002FⅡ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma who had no standard treatment available, or were intolerant to standard treatment.",[206,78],{"date":209,"type":42},{"date":229,"type":42},"2023-10-27",{"date":231,"type":20},"2026-10",{"name":88,"class":89},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":253,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":266},"100541703","phase-2-dostarlimab-for-locally-advanced-or-metastatic-cancer-non-colorectalnon-endometrial-with-tumor-dmmrmsi-100541703","NCT06333314","Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal\u002FNon-endometrial) With Tumor dMMR\u002FMSI","Dostarlimab as First-line Treatment for Patients With dMMR\u002FMSI (Non-colorectal\u002FNon-endometrial) Locally Advanced or Metastatic Cancer: a Randomized Phase 2 Trial (Cohort Pan-MSI ACSE) With Crossover in the Standard Arm at Progression","Pan-MSI-ACSE","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent form prior any trial specific procedures. -\n2. 18 years or older patients.\n3. Documented locally advanced or metastatic disease with no previous systemic anti-cancer treatment in these settings and not suitable for complete surgical resection.\n4. Histologically proven, dMMR\u002FMSI-H solid tumors that are not colorectal or endometrial cancers and including one of the following: duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction adenocarcinoma with CPS\\\u003C5, pancreatic adenocarcinoma, ampulla of Vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade 3) all primary, and soft tissue sarcoma except Gastro-Intestinal Stromal Tumor (GIST).\n5. If patient received adjuvant therapy for non-metastatic disease, this therapy should be completed more than 6 months before the diagnosis of metastatic or recurrent disease.\n6. Availability of minimum 1 block of tumor tissue or 20 slides (archival (\\\u003C2 years) or fresh biopsy specimen of primary and or metastasis) for centralized confirmation of MMR\u002FMSI status by IHC or NGS\u002FPCR, and for Translational Research.\n7. Patients with dMMR\u002FMSI tumor analyzed by IHC, PCR (for Gastric and OGJ adenocarcinoma, and duodenum and small bowel adenocarcinoma only), and\u002For NGS at the recruiting center should be confirmed by central review within 24h (every anonymized patient analysis reporting will be provided for central review). Patients should not be included in the study until the dMMR\u002FMSI status is confirmed by the review committee.\n\n   NB: In case of ambiguous result of IHC (lack of positive internal control, heterogeneous loss of MMR protein expression, ambiguous loss of only one protein including HMSH6 and PMS2), the MSI-H status will be assessed by PCR or NGS for gastric and OGJ adenocarcinoma, and duodenum and small bowel adenocarcinoma, and by NGS for other primary. Based on IHC and PCR or NGS results (NGS will be centrally performed in this case ), the sponsor will decide if inclusion is possible;\n8. Presence of at least one measurable lesion within 28 days before the start of treatment according to RECIST v1.1.\n9. Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1.\n10. Haematological status: absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL; platelets ≥100 x 10⁹\u002FL; haemoglobin ≥9 g\u002FdL.\n11. Adequate renal function: serum creatinine level \\\u003C120 µM, or clearance \\>50 ml\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\] or Cockcroft and Gault).\n12. Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless liver metastases are present, in which case they must be ≤ 5× ULN.\n13. For patients not taking warfarin: International normalised ratio (INR) \\\u003C1.5 or prothrombin time (PT) \\\u003C1.5 x ULN and either partial thromboplastin time (PTT) or activated PTT (aPTT) \\\u003C1.5 x ULN. Participants taking warfarin may be included on a stable dose with a therapeutic INR \\\u003C3.5.\n14. Women of childbearing potential must have a negative serum pregnancy test performed within 72 hours before the date of randomization.\n15. Men, and women of childbearing potential must agree to use adequate contraception for the duration of trial participation and for 4 months after the last dose of dostarlimab (used in first line or at crossover) or for at least 6 months after the last administration of the chemotherapy agent(s) used in the control arm if no crossover with dostarlimab (according to the current version of the summary of product characteristics (SmPC) of each chemotherapy agent). Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n16. Registration in a National Health Care System.\n17. Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.\n\nExclusion Criteria:\n\n1. Colorectal and endometrial cancer and all primary tumor not listed in inclusion criterion #4.\n2. Previous exposure to anti-PD-1 or PD-L1 or anti-CTL-4 antibodies or treatment with immunotherapy.\n3. Previous exposure to any investigational drug within 4 weeks (6 weeks for monoclonal antibodies) before the first dose in the study.\n4. Previous exposure to any systemic anti-cancer therapy or radiation therapy for the cancer for which the patient is being enrolled.\n5. Active autoimmune disease: Active autoimmune disease requiring systemic treatment in the past 2 years (excluding replacement therapy) or any history of interstitial lung disease (patients with ancient auto-immune disease with stable endocrine oral substitution are eligible).\n6. Uncontrolled central nervous system metastases or carcinomatous meningitis or other concurrent illness or ongoing or active infections.\n7. Patients with HER2-positive gastric carcinoma.\n8. Other serious and uncontrolled non-malignant disease or is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n9. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n10. Has received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of adjuvant treatment or is required to receive systemic immunosuppressive medications during the study. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n\n    Note 1: Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled into the study after approval of the Medical Contact.\n\n    Note 2: patients are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses including doses \\>10 mg daily prednisone are permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.\n11. Other concomitant or previous malignancy other than the disease under study, except as noted below:\n\n    i. adequately treated in-situ carcinoma of the uterine cervix, ii. basal or squamous cell carcinoma of the skin, iii. cancer from which the patients was in complete remission for \\>2 years.\n12. Known Human Immunodeficiency Virus (HIV) infection.\n13. Received live vaccine within 14 days.\n14. Patient has documented presence of HBsAg \\[or HBcAb\\] at pre-inclusion visit or within 3 months prior to first dose of study intervention.\n\n    Participant has a positive hepatitis C virus (HCV) antibody test result at pre-inclusion visit or within 3 months prior to first dose of study intervention. Note: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled, only if a confirmatory negative HCV RNA test is obtained.\n\n    Participant has a positive HCV RNA test result at pre-inclusion visit or within 3 months prior to first dose of study intervention. Note: The HCV RNA test is optional and participants with negative HCV antibody test are not required to undergo HCV RNA testing as well\n15. Known prior severe hypersensitivity to investigational product or any component in its formulation.\n16. Pregnant or breast feeding women.\n17. Participation in another clinical trial within 30 days prior to the first study treatment administration or concomitantly with the trial.\n18. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n19. Person deprived of their liberty or under protective custody or guardianship.\n\nPatient randomized to receive SOC (Arm B) may crossover to receive dostarlimab (Arm A) in case of documented progressive disease according to RECIST v1.1.\n\nInclusion and exclusion are the same for the crossover except for the inclusion criteria #3 and #4.\n\nThe criterion #3 for crossover is: Patient included in the protocol and randomized in the arm \"standard of care\" with documented progressive disease by RECIST v1.1 on standard of care (defined in the protocol).\n\nThe criterion #4 for crossover is: Previous exposure to chemotherapy for locally advanced or metastatic disease.",{"count":242,"type":20},120,[23],"The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)\u002Fmicrosatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.\n\nAdult patients (aged ≥18 years) with histologically confirmed dMMR\u002FMSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\\\u003C5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).\n\nPatients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A.",[246,247,248,78,249,250,251,252],"Pancreatic Adenocarcinoma","Ampulla of Vater Carcinoma","Adrenocortical Carcinoma","Soft Tissue Sarcoma","Small Bowel Adenocarcinoma","Duodenum Adenocarcinoma","Gastric Adenocarcinoma",[254,255,256],"Immunotherapy","locally advanced or metastatic cancer","dMMR\u002FMSI (non-colorectal\u002Fnon-endometrial) cancer","2025-11-24",{"date":259,"type":42},"2025-12-02",{"date":261,"type":42},"2024-07-23",{"date":263,"type":20},"2030-09",{"name":265,"class":113},"UNICANCER",22,{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":134},"100387491","phase-2-chemotherapy-for-metastatic-grade-3-poorly-differentiated-neuroendocrine-carcinoma-of-gastroenteropancreatic-and-unknown-primary-100387491","NCT04325425","Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary","Folfirinox Versus Platinum - Etoposide as First Line Chemotherapy for Metastatic Grade 3 Poorly Differentiated Neuroendocrine Carcinoma of Gastro Entero Pancreatic and Unknown Primary Associated With Molecular Profiling for Therapeutic Targets & Predictive Biomarkers Identification","FOLFIRINEC","Inclusion Criteria:\n\n* Grade 3 neuroendocrine carcinoma or high grade MiNEN with a grade 3 poorly differentiated neuroendocrine carcinoma component ≥30% of gastro-entero-pancreatic or unknown primary\n\n  * Poorly differentiated\n  * Small cell or large cell or non-small cell or non- typeable\n  * Metastatic disease\n  * First-line, no prior therapy for metastatic disease, no prior use of carboplatin, oxaliplatin, cisplatin, etoposide, irinotecan and 5-fluorouracile\n  * At least one measurable lesion as assessed by CT-scan or MRI according to RECIST 1.1 guidelines\n  * Available tumor block\n  * ANC ≥ 1.5x109\u002Fl, platelet ≥ 100x109\u002Fl and hemoglobin \\> 8 g\u002Fdl\n  * Total bilirubin ≤ 1.5N, AST ≤ 2.5N, ALT≤ 2.5N or AST\u002FALT ≤ 5N in case of liver metastases.\n  * Age ≥ 18 years\n  * ECOG Performance Status ≤ 1\n  * Signed and dated informed consent, and willing and able to comply with protocol requirements.\n  * Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study and during the 15 months following administration of the last dose of the study medicinal product\n  * Patient who is a beneficiary of the Social security system\n\nExclusion Criteria:\n\n* Grade 3 well differentiated neuroendocrine tumor according to WHO 2017 classification\n\n  * Severe renal impairment (creatinine clearance less than 30 mL\u002Fmin, MDRD)\n  * Partial or complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng\u002FmL)\n  * Gilbert's syndrome\n  * Pre-existing permanent neuropathy (NCI CTC V4.0 grade ≥2)\n  * Previously treated by chemotherapy or targeted therapy\n  * Brain metastases unless they are asymptomatic or under stable corticosteroid doses for 2 weeks otherwise. Radiation therapy prior to inclusion is required if symptomatic.\n  * Combination with sorivudine and others analogues as brivudine (irreversibly inhibits the enzyme dihydropyrimidine dehydrogenase)\n  * Treatment with St John's Wort (Hypericum perforatum)\n  * Pregnant women or breastfeeding mother\n  * Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C\n  * History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.\n  * Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study\n  * vaccinations (live vaccine) within 30 days prior to start of study drugs\n  * Patient under guardianship and\u002For deprived of his\u002Fher freedom\n  * QT\u002FQTc interval \\> 450 msec for male and \\> 470 msec for female at EKC.\n  * K+ \\\u003C LLN, Mg²+ \\\u003C LLN, Ca²+ \\\u003C LLN\n  * History or know hypersensitivity to any of the study chemotherapy agents, or their excipients",{"count":276,"type":20},218,[23],"there is a need for improving chemotherapy regimen for metastatic G3 NEC of GEP and Unknown origin and this goal may be achieved through more \"personalized\" chemotherapy regimen.the hypothesis is that mFOLFIRINOX regimen could be a good candidate for challenging the platinum-etoposide regimen in patients with metastatic G3 NEC of GEP or unknown origin. Furthermore, in order to get insights in the putative predictive biomarkers of efficacy of these two regimens, an effort toward a precise molecular characterization of these tumors is required in order to be able to define which subgroup of G3 NEC needs to be treated by which chemotherapy regimen. The FOLFIRINEC trial is set up in order to try to answer these questions",[78],"2025-09-25",{"date":282,"type":42},"2025-09-30",{"date":284,"type":42},"2020-09-01",{"date":286,"type":20},"2029-09",{"name":288,"class":113},"Centre Hospitalier Universitaire Dijon",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":15,"minAge":296,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":310,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":323},"100560503","phase-1-safetyefficacy-study-of-cid-078-in-patients-with-advanced-solid-tumor-malignancies-100560503","NCT06577987","Safety\u002FEfficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies","A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Cyclin A\u002FB-RxL Inhibitor CID-078 in Patients With Advanced Solid Tumor Malignancies","Part 1a\u002F1b Inclusion Criteria:\n\nA patient must meet all of the following inclusion criteria to be eligible to participate in this study.\n\n1. Solid tumor malignancy meeting the following criteria:\n\n   * Part 1a Dose Escalation and Part 1b New Formulation Dose Escalation\u002FPilot Food Effect Cohort: locally advanced or metastatic solid tumor malignancy that has progressed or was non responsive to available therapies and for which no standard or available curative therapy exists.\n   * Part 1a and Part 1b Backfill: patients with TNBC, SCLC, and solid tumors harboring a RB1 or CDKN2A\u002FB loss genomic alteration or Rb protein LoF. Additional tumor types or genomic alterations may be considered by the SRC as data become available. Patient must have progressed or was non-responsive to available therapies and for which no standard or available curative therapy exists\n2. Measurable disease per RECIST v1.1.\n3. Age ≥ 18 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n5. Life expectancy \\> 12 weeks.\n6. Able to undergo a fresh biopsy if medically feasible.\n7. Ability to swallow capsules by mouth.\n8. Have the following laboratory values:\n\n   1. Calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 by Cockroft-Gault formula (actual body weight must be used for CrCl unless body mass index \\[BMI\\] is \\> 30 kg\u002Fm2, then lean or ideal body weight must be used (based on institutional practice), or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 based alternative methods of determination (e.g., modification of diet in renal disease \\[MDRD\\], 24-hour urine collection) if consistent with local or institutional practice.\n   2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless prior history of Gilbert's syndrome with Sponsor Medical Monitor approval.\n   3. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor.\n   4. Hemoglobin ≥ 9.0 g\u002FdL (last transfusion \\> 14 days prior to first dose of study drug).\n   5. Platelets ≥ 100 × 10\\^9 cells\u002FL (last platelet transfusion \\> 14 days prior to first dose of study drug).\n   6. Absolute neutrophil count ≥ 1.2 × 10\\^9 cells\u002FL (last dose of hematopoietic growth factors \\> 14 days from first dose of study drug).\n9. Females of childbearing potential must commit to sexual abstinence or to use two acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, or any form of hormonal contraceptives) for the duration of the study and for four months following the last dose of study treatment. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential. Male patients must be sterile (biologically or surgically), commit to sexual abstinence or to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for four months following the last dose of study treatment.\n10. Females of childbearing potential must have a negative serum pregnancy test during Screening and a negative urine or serum pregnancy test prior to receiving the first dose of study drug. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential.\n11. Signed and dated Institutional Review Board (IRB)\u002FEthics Committee (EC)-approved ICF before any protocol-directed screening procedures are performed.\n\n    Part 1b Pilot Food Effect Cohort - Specific Inclusion Criteria\n\n    Patients who consent to participate in the pilot food effect cohort will also be required to meet the following inclusion criteria:\n12. Able to eat a standardized high-fat, high-caloric or low-fat meal (as applicable to the food effect cohort assigned) within 25 minutes.\n\nExclusion Criteria:\n\nA patient who meets any of the following exclusion criteria will be ineligible to participate in this study:\n\n1. Treatment with any of the following:\n\n   1. Targeted therapy ≤ eight days or 5× the terminal phase elimination half-lives, whichever is shorter, prior to the first dose of study drug.\n   2. Systemic anticancer treatment (excluding targeted therapy as described above) ≤ 14 days prior to first dose of study drug.\n   3. Radiotherapy ≤ 28 days and palliative radiation ≤ 14 days prior to the first dose of study drug. If irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions.\n   4. Immunotherapy ≤ 28 days prior to the first dose of study drug.\n   5. Major surgery ≤ 28 days prior to the first dose of study drug.\n2. Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor Medical Monitor.\n3. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, treated with surgery and\u002For radiation, and has been stable without requiring escalating doses of corticosteroids or anti-convulsant medications for at least four weeks prior for the first dose of study drug.\n4. Prior therapy with CID-078.\n5. Known hypersensitivity to CID-078 or any drugs similar in structure or class.\n6. Past medical history of interstitial lung disease, or any evidence of clinically active interstitial lung disease. Patients with sub-clinical pneumonitis who have received anti-cancer therapy (e.g., immunotherapy, ADC) previously can be included if their condition is stable without any medical intervention.\n7. Patient has a history of congestive heart failure (CHF) Class III\u002FIV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.\n8. Heart rate corrected QT (QTc) interval (using Fridericia correction calculation) \\> 470 msec.\n9. Current treatment with medication known to prolong the QT\u002FQTc interval (see examples from Table 28) or history of additional risk factors for Torsade de Pointes (e.g., heart failure, Grade ≥ 3 hypokalemia, family history of long QT syndrome). Patient who has adequately controlled condition or requires use of medications from Table 28 may be allowed upon agreement by the Investigator and Sponsor Medical Monitor.\n10. Pregnant or lactating women.\n11. History of another primary malignancy ≤ two years prior to starting study drug, except for adequately treated cancer (e.g., basal, or squamous cell carcinoma of the skin or cancer of the cervix in situ).\n12. Malabsorption syndrome or other conditions (e.g., refractory nausea and vomiting, external biliary diversion, or any significant small bowel resection) that may interfere with adequate absorption of investigational product.\n13. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including untreated human immunodeficiency virus \\[HIV\\] and active clinical tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n14. Current endocrinopathies, unless in the opinion of the Investigator, endocrine complications are stable and well controlled and study participation does not jeopardize patient's health and wellbeing. Patients with asymptomatic endocrine disease on endocrine replacement therapy are eligible.\n15. Active hepatitis B infection as defined by a positive hepatitis B surface antigen (HbsAg) test and detectable hepatitis B virus (HBV) DNA. Patients ineligible due to detectable levels of HBV DNA at baseline may be rescreened for enrollment if their HBV DNA levels become undetectable after treatment with antiviral agents, and upon agreement between the Investigator and Sponsor Medical Monitor.\n16. Active hepatitis C infection as defined by a reactive hepatitis C virus (HCV) antibody test and detectable HCV RNA.\n17. For patients with a history of HIV or acquired immunodeficiency syndrome (AIDS):\n\n    1. Must have a CD4+ T-cell count ≥ 350 cells\u002FμL\n    2. Have not had an opportunistic infection within the previous 12 months.\n    3. To be on current antiretroviral therapy (ART) regimen for a minimum of four weeks and have an HIV viral load \\\u003C 400 copies\u002FmL at the time of enrollment.\n    4. Patients who are using concurrent strong cytochrome P450 (CYP)3A4 inhibitors (e.g., ritonavir, cobicistat) or strong CYP3A4 inducers are excluded from the study if their regimen cannot be altered. Otherwise, eligible study patients could be switched to an alternate effective ART before study participation.\n18. Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 14 days or five terminal half-lives prior to the first dose of study drug, whichever is shorter.\n19. Active bleeding disorders.\n20. Prior solid organ transplantation.\n21. Is, in the Investigator's opinion, unable or unwilling to comply with the study procedures.\n22. Have any condition or illness that, in the opinion of the Investigator, might compromise patient safety or interfere with the evaluation of the safety of the study drug.\n\nStudy Population (Part 2 Dose Expansion):\n\nInclusion Criteria:\n\nA patient must meet all of the following inclusion criteria to be eligible to participate in this study.\n\n1. Advanced or metastatic solid tumor malignancy that has progressed or was non responsive to available therapies and for which no standard or available curative therapy exists.\n\n   1. Triple negative breast cancer (TNBC) cohort: histologically or cytologically confirmed TNBC per American Society for Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) criteria, based on the most recent analyzed biopsy or other pathology specimen.\n   2. Small cell lung cancer (SCLC) cohort: histologically or cytologically confirmed relapsed\u002Frefractory SCLC.\n   3. Retinoblastoma 1 (RB1)-altered solid tumor cohort: solid tumors harboring a documented RB1 genomic alteration or Rb protein LoF, as identified through assays performed at Clinical Laboratory Improvement Amendments (CLIA)-certified or other similarly certified laboratories.\n2. Patients must have measurable disease by RECIST v1.1.\n3. Age ≥ 12 years and at least 40 kg in body weight.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (patients ≥ 18 years of age), Karnofsky performance status ≥ 70% (patients ≥ 16 to \\\u003C 18 years of age), or Lansky performance status ≥ 70% (patients \\\u003C 16 years of age). Patients who are unable to walk because of paralysis, but who can sit in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score (Appendix 1).\n5. Life expectancy \\>12 weeks.\n6. For patients ≥ 18 years of age: able to undergo a fresh biopsy if medically feasible.\n7. Ability to swallow capsules by mouth.\n8. Have the following laboratory values:\n\n   1. For patients ≥ 18 years of age: calculated CrCl ≥ 60 mL\u002Fmin\u002F1.73 m2 by Cockroft-Gault formula (actual body weight must be used for CrCl unless BMI \\> 30 kg\u002Fm2 then lean or ideal body weight must be used based on institutional practice), or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 based alternative methods of determination (e.g., modification of diet in renal disease \\[MDRD\\], 24-hour urine collection) if consistent with local or institutional practice. For patients \\\u003C 18 years of age: serum creatinine within normal limits (as defined below) or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 based on local institutional practice for determination.\n\n      Age at Screening Maximum Serum Creatinine SI Unit age 12 to \\\u003C 15 years - 0.81 mg\u002FdL; age 15 to \\\u003C 18 years (male) - 1.08 mg\u002FdL; age 15 to \\\u003C 18 years (female) - 0.84 mg\u002FdL\n   2. Total bilirubin ≤ 1.5 × ULN unless prior history of Gilbert's syndrome with Sponsor Medical Monitor approval.\n   3. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor.\n   4. Hemoglobin ≥ 9.0 g\u002FdL (last transfusion \\> 14 days prior to first dose of study drug).\n   5. Platelets ≥ 100 × 10\\^9 cells\u002FL (last platelet transfusion \\> 14 days prior to first dose of study drug).\n   6. Absolute neutrophil count ≥ 1.2 ×10\\^9 cells\u002FL (last dose of hematopoietic growth factors \\> 14 days from first dose of study drug).\n9. Females of childbearing potential must commit to sexual abstinence or to use two acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) for the duration of the study and for four months following the last dose of study treatment. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential. Male patients must be sterile (biologically or surgically), commit to sexual abstinence or to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for four months following the last dose of study treatment.\n10. Females of childbearing potential must have a negative serum pregnancy test during Screening and a negative urine or serum test prior to receiving first dose of study drug. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential.\n11. Signed and dated IRB\u002FEC-approved ICF for potential patients ≥ 18 years of age. A signed and dated IRB\u002FEC-approved adolescent assent form may also be required for patients 12 to 17 years of age in addition to an ICF signed by a parent or legal guardian.\n\nExclusion Criteria:\n\nA patient who meets any of the following exclusion criteria will be ineligible to participate in this study.\n\n1. Treatment with any of the following:\n\n   1. Targeted therapy ≤ eight days or 5× the terminal phase elimination half-lives, whichever is shorter, prior to the first dose of study drug.\n   2. Systemic anticancer treatment (excluding targeted therapy as described above) ≤ 14 days prior to the first dose of study drug.\n   3. Radiotherapy ≤ 28 days and palliative radiation ≤ 14 days prior to the first dose of study drug. If irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions.\n   4. Immunotherapy ≤ 28 days prior to the first dose of study drug.\n   5. Major surgery ≤ 28 days prior to the first dose of study drug.\n2. Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor Medical Monitor.\n3. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, treated with surgery and\u002For radiation, and has been stable without requiring escalating doses of corticosteroids or anti-convulsant medications for at least four weeks prior to the first dose of study drug.\n4. Prior therapy with CID-078.\n5. Known hypersensitivity to CID-078 or any drugs similar in structure or class.\n6. Past medical history of interstitial lung disease or any evidence of clinically active interstitial lung disease. Patients with sub-clinical pneumonitis who have received anti-cancer therapy (e.g., immunotherapy, ADC) previously can be included if their condition is stable without any medical intervention.\n7. Patient has a history of CHF Class III\u002FIV according to the NYHA Functional Classification Appendix 2) or serious cardiac arrhythmias requiring treatment.\n8. QTc interval (using Fridericia correction calculation) (QTcF) \\> 470 msec.\n9. Current treatment with medication known to prolong the QT\u002FQTcF interval or history of additional risk factors for Torsade de Pointes (e.g., heart failure, Grade ≥ 3 hypokalemia, family history of long QT syndrome). Patient who has adequately controlled condition or require use of medications from Table 28 may be allowed to enroll upon agreement by the Investigator and Sponsor Medical Monitor.\n10. Pregnant or lactating women.\n11. History of another primary malignancy ≤ two years prior to starting study drug, except for adequately treated cancer (e.g., basal or squamous cell carcinoma of the skin or cancer of the cervix in situ).\n12. Malabsorption syndrome or other conditions (e.g., refractory nausea and vomiting, external biliary diversion, or any significant small bowel resection) that may interfere with adequate absorption of investigational product.\n13. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including untreated HIV and active clinical tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n14. Current endocrinopathies, unless in the opinion of the Investigator, endocrine complications are stable and well controlled and study participation does not jeopardize patient's health and wellbeing. Patients with asymptomatic endocrine disease on endocrine replacement therapy are eligible.\n15. Active hepatitis B infection as defined by a positive HBsAg test and detectable HBV DNA. Patients ineligible due to detectable levels of HBV DNA at baseline may be rescreened for enrollment if their HBV DNA levels become undetectable after treatment with antiviral agents, and upon agreement between the Investigator and Sponsor Medical Monitor.\n16. Active hepatitis C infection as defined by a reactive HCV antibody test and detectable HCV RNA.\n17. For patients with a history of HIV or AIDS:\n\n    1. Must have a CD4+ T-cell count ≥ 350 cells\u002FμL.\n    2. Have not had an opportunistic infection within the previous 12 months.\n    3. To be on current ART regimen for a minimum of four weeks and have an HIV viral load \\\u003C 400 copies\u002FmL at the time of enrollment.\n    4. Patients who are using concurrent strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat) or strong CYP3A4 inducers are excluded from the study if their regimen cannot be altered. Otherwise, eligible study patients could be switched to an alternate effective ART regimen before study participation.\n18. Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate as specifically listed in Table 26 and Table 27 within 14 days or five terminal half-lives prior to the first dose of study drug, whichever is shorter.\n19. Active bleeding disorders.\n20. Prior solid organ transplantation.\n21. Is, in the Investigator's opinion, unable or unwilling to comply with the study procedures.\n22. Have any condition or illness that, in the opinion of the Investigator, might compromise patient safety or interfere with the evaluation of the safety of the study drug.","12 Years",{"count":298,"type":20},220,[100],"This is a first-in-human, multicenter, open-label, phase 1 study to evaluate safety, tolerability, and efficacy of CID-078, a Cyclin A\u002FB-RxL inhibitor, in patients with advanced solid tumors.",[302,303,304,305,306,307,308,103,78,309],"Advanced Solid Tumor","Metastatic Solid Tumor","Refractory Solid Tumor","Cancer","Lung Cancer","Triple Negative Breast Cancer","Breast Neoplasms","RB1 Gene Mutation",[311,312,313],"Phase 1","CID-078","Estrogen","2025-09-09",{"date":316,"type":42},"2025-09-15",{"date":318,"type":42},"2024-08-14",{"date":320,"type":20},"2027-03-14",{"name":322,"class":89},"Circle Pharma",10,{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":21,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"100383091","phase-2-efficacy-of-neoadjuvant-chemotherapy-in-terms-of-dfs-in-patients-with-localized-digestive-neuroendocrine-carcinomas-100383091","NCT04268121","Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas","Phase II Study to Evaluate the Efficacy of 12-month Neoadjuvant Chemotherapy in Terms of Disease-free Survival in Patients With Localized Digestive Neuroendocrine Carcinomas","NEONEC","Inclusion Criteria:\n\nPhase II\n\n1. Histologically proven digestive CNE, (the WHO 2017 classification: poorly differentiated and Ki 67 \\> 20%),\n2. Patients with localized CNE, without metastasis (computed tomography \\[CT\\], thoraco-abdominopelvic CT scan \\[TAP\\] according to RECIST 1.1; examinations performed no later than 21 days before starting the study treatment, possible locoregional lymph node involvement defined according to the TNM classification),\n3. Positron emission tomography (PET) and CT for lymph node status and elimination of secondary visceral and\u002For bone disorders, 4. Resectable tumor, according to the consensus decision made during local multidisciplinary surgical consultation meeting,\n\n5\\. Age ≥ 18 years, 6. Written informed consent obtained from the patient, willing and able to comply with the protocol, 7. Registration in a National Health Care System (Protection Universelle Maladie \\[PUMa\\] included), 8. For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment.\n\nMen and women are required to use a reliable and adequate birth control during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration.\n\nProspective cohort\n\n1. Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67\\> 20%),\n2. Localized, without metastasis on computed tomography \\[CT\\], thoracoabdominopelvic CT scan \\[TAP\\] RECIST 1.1, and\u002For locoregional lymph node involvement,\n3. Age ≥ 18 years,\n4. Written informed consent obtained from the patient, willing and able to comply with the protocol,\n5. Registration in a National Health Care System (PUMa - Protection Universelle Maladie included),\n6. For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment.\n\nMen and women are required to use a reliable and adequate birth control methods during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration.\n\nExclusion Criteria:\n\nPhase II\n\n1. Well-differentiated NEC, whatever the grade,\n2. Metastatic disease,\n3. Cancer of unknown primary\n4. Organ failure that does not allow chemotherapy treatment,\n5. Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ\n6. Tumor with a mixed component (component accounts for ≥ 30%),\n7. Patient impossible to follow-up,\n8. Other than platinum-etoposide chemotherapy administrated,\n9. Tutelage or guardianship or patient protected by law\n\nProspective cohort\n\n1. Well-differentiated NEC, whatever the grade,\n2. Metastatic disease,\n3. Cancer of unknown primary\n4. Organ failure that does not allow chemotherapy treatment,\n5. Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ\n6. Tumor with a mixed component (component accounts for ≥ 30%),\n7. Patient impossible to follow-up,\n8. Other than platinum-etoposide chemotherapy administrated,\n9. Tutelage or guardianship or patient protected by law.",{"count":333,"type":20},78,[23],"NEONEC is a single-phase, phase II study evaluating the efficacy of the 12-month neoadjuvant chemotherapy in patients with locally differentiated digestive NEC. The recommended chemotherapy is based on the current reference combination of platinum (cisplatin or carboplatin) and etoposide (VP16). For anorectal locations, radiochemotherapy is proposed to avoid the morbidity of conventional surgery.\n\nThe objective of the study is to improve relapse-free survival (RFS) in NEC patients treated with neoadjuvant chemotherapy followed by surgery or chemoradiotherapy.\n\nIn parallel, we will perform a prospective cohort study with patients whose diagnosis is made during surgery, who have not received neoadjuvant treatment, and who are offered an adjuvant treatment of the same type (combination of platinum and platinum salts and etoposide).",[78,337],"Digestive Cancer",[339,340],"Neoadjuvant treatment","Adjuvant treatment","2025-07-22",{"date":343,"type":42},"2025-07-23",{"date":345,"type":42},"2021-01-05",{"date":347,"type":20},"2031-01",{"name":349,"class":113},"GERCOR - Multidisciplinary Oncology Cooperative Group",14,{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":361,"conditions":362,"keywords":366,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":50},"100398130","rediscovering-biomarkers-for-the-diagnosis-and-early-treatment-response-in-nen-reborn-100398130","NCT04464122","Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)","Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study","REBORN","Inclusion Criteria:\n\n* Histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to first line medical therapy (study group);\n* Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (control group).\n\nExclusion Criteria:\n\n* Severe chronic kidney disease (stage 4-5);\n* Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease;\n* Other non-neuroendocrine malignancies.","80 Years",{"count":19,"type":20},"This is a multicentre, controlled, observational prospective study on new biomarkers, as immune profiling, angiogenetic markers and circRNA from TEPs in the diagnosis and in the evaluation of treatment response in pulmonary and gastro-entero-pancreatic NENs.",[103,363,364,365,78],"Neuroendocrine Neoplasm","Neuroendocrine Tumor Grade 1","Neuroendocrine Tumor Grade 2",[367,368,369,370,371],"Neuroendocrine Tumours","Prognostic markers","Tumour educated platelets","angiogenesis","immune function","2025-03-31",{"date":374,"type":42},"2025-04-03",{"date":376,"type":42},"2020-09-14",{"date":378,"type":20},"2025-12-31",{"name":380,"class":113},"University of Roma La Sapienza",{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":391,"conditions":392,"keywords":397,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":50},"100534691","clinical-application-of-the-j-pet-scanner-prototype-100534691","NCT06242119","Clinical Application of the J-PET Scanner Prototype","Clinical Use of a J-PET Scanner Prototype Made of Plastic Scintilators","JPET2Clinic","Inclusion Criteria:\n\n* The patient is referred for a PET\u002FCT scan, in accordance with recognized indications for examining the entire body.\n* Age over 18 years\n* Informed, voluntary consent to participate in the study\n\nExclusion Criteria:\n\n* Pregnant women, breastfeeding women\n* People with a previously diagnosed allergy to radiopharmaceuticals\n* Age under 18 years\n* Lack of cooperation with the patient\n* Lack of informed consent to participate in the study",{"count":390,"type":20},25,"Positron emission tomography (PET), an advanced diagnostic imaging technique, exploits the annihilation of positrons (e+) to delineate pathological alterations within diseased tissues. Integral to PET scanners are detector systems that transform gamma photons into fluorescent photons, thereby gleaning insights into the energy, time, and spatial distribution of gamma photons emanating from positron-emitting radiopharmaceuticals. Conventional PET scanners, bear a significant financial burden primarily due to their reliance on LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals. The exorbitant cost and limited availability of these crystal scintillators impede the widespread adoption of PET scanners. In a departure from conventional PET technology, the prototype J-PET scanner employed in this trial employs plastic scintillators, characterized by unique physical properties. This prototype is further equipped with bespoke software enabling three-photon imaging based on the annihilation of ortho-positronium (o-Ps) generated within diseased tissue. This study delves into the clinical applicability of PET scanners employing plastic scintillators, particularly investigating the feasibility of PET imaging using plastic scintillators where gamma quanta interact by mechanisms other than the photoelectric effect. Furthermore, this study endeavors to contemporaneously acquire and analyze data related to the lifetime of ortho-positronium (o-P) atoms emanating from routine radiopharmaceuticals. Additionally, it seeks to validate the utilization of a novel diagnostic indicator, termed the \\"positron biomarker,\\" through a prospective study, comparing its efficacy to conventional diagnostic PET scanning methodologies.",[393,394,395,396,103,78],"Prostate Cancer","Prostatic Hyperplasia","Prostatic Neoplasms","Prostate Cancer Metastatic",[398,399,400,401,402,403],"positronium","PET","[18F]FDG","[18F]choline","[68Ga]Ga-DOTA-TATE","[68Ga]Ga-PSMA","2025-02-17",{"date":406,"type":42},"2025-02-19",{"date":408,"type":42},"2024-03-07",{"date":410,"type":20},"2025-10-30",{"name":412,"class":113},"Jagiellonian University",{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":420,"targetDuration":4,"studyType":21,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":430,"locationsCount":50},"100549899","phase-1-dose-escalation-study-of-zg006-in-participants-with-advanced-small-cell-lung-cancer-or-neuroendocrine-carcinoma-followed-by-dose-expansion-study-in-participants-with-neuroendocrine-carcinoma-100549899","NCT06440057","Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.","A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years of age;\n* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* Participants were deemed unsuitable for participating in the study by the investigator for any reason.",{"count":333,"type":20},[100,23],"This is a multicenter, open-label phase I\u002FII study, divided into 2 parts:\n\nPart 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.\n\nPart 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.",[78],"2024-12-11",{"date":426,"type":42},"2024-12-16",{"date":428,"type":42},"2024-08-29",{"date":84,"type":20},{"name":88,"class":89},{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":200,"enrollmentInfo":438,"targetDuration":4,"studyType":21,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":50},"100544725","phase-1-study-of-zg005-in-combination-with-etoposide-and-cisplatin-in-participants-with-advanced-neuroendocrine-carcinoma-100544725","NCT06372626","Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.","A Phase I\u002FII Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Histologically confirmed recurrent or metastatic neuroendocrine carcinoma\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases;\n* Any other malignancy within 5 years.\n* participants were deemed unsuitable for participating in the study by the investigator for any reasons.",{"count":439,"type":20},93,[100,23],"The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.",[78],"2024-06-13",{"date":445,"type":42},"2024-06-14",{"date":447,"type":42},"2024-05-30",{"date":449,"type":20},"2026-08",{"name":88,"class":89},{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":460,"conditions":461,"keywords":464,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":50},"100544461","neuroendocrine-transformation-in-rb1tp53-inactivated-nsclc-100544461","NCT06369181","Neuroendocrine Transformation in RB1\u002FTP53 Inactivated NSCLC","Neuroendocrine Transformation in RB1 and TP53 Inactivated Non-small Cell Lung Cancer Patients: a Multi-center Prospective Observational Study","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. ECOG function status score 0-2 points;\n3. Pathological diagnosis of stage III-IV non neuroendocrine non-small cell lung cancer;\n4. RB1\u002FTP53 gene\u002Fprotein testing (IHC, NGS, or other techniques are acceptable) has been completed and confirmed to be dual inactivation of RB1\u002FTP53;\n5. For patients with baseline pathology of adenocarcinoma, complete driver gene testing (including at least EGFR and ALK);\n6. The patient undergoes at least one systemic treatment (chemotherapy, targeted drug therapy, immunotherapy, etc.) and receives regular follow-up;\n7. After discovering disease progression during the follow-up process, the patient will undergo further pathological biopsy of the progressing lesion after evaluation by the sub center PI;\n8. According to the researcher's assessment, the patient currently does not require palliative radiation therapy in any area;\n9. If the subject undergoes surgery, they must fully recover from the toxicity and complications of the surgical intervention before starting treatment;\n10. The subjects need to agree to provide corresponding peripheral blood and biopsy tissue samples before and during the follow-up treatment in accordance with the clinical trial protocol requirements;\n11. Men\u002Fwomen of childbearing age agree to use contraception during the trial period (surgical ligation or oral contraception\u002Fintrauterine device+condom contraception);\n12. Life expectancy ≥ 3 months;\n13. Patients must have the ability to understand and voluntarily sign informed consent forms.\n\nExclusion Criteria:\n\n1. Baseline pathological examination reveals neuroendocrine components (including any percentage of small cell carcinoma, large cell carcinoma, differentiated neuroendocrine carcinoma, etc);\n2. Unable to perform RB1\u002FTP53 testing ;\n3. Patients with baseline pathology of adenocarcinoma and inability to perform driver gene testing (including at least EGFR, ALK);\n4. Symptomatic interstitial lung disease or active infection\u002Fnon infectious pneumonia;\n5. History of other malignant tumors;\n6. Physical examination or clinical trial findings that researchers believe may interfere with the results or increase the risk of treatment complications for patients, or other uncontrollable diseases\n7. Breastfeeding or pregnant women;\n8. Congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV), or a history of organ transplantation or allogeneic stem cell transplantation;\n9. Patients who require long-term treatment with cortisol or immunosuppressants;\n10. Patients with mental illnesses, substance abuse, or social issues that affect compliance will not be included in the group after being reviewed by a doctor\n11. Individuals who receive other long-term medication treatments and have been assessed by a doctor as potentially affecting disease progression.",{"count":459,"type":20},50,"Histology transformation from non-small cell lung cancer (NSCLC) to neuroendocrine carcinomas (NEC), especially from epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma (LADC) to small cell lung cancer (SCLC), is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors (TKIs) resistance. The probability of its occurrence is about 3-14% in NSCLC patients who are resistant to TKI treatment. In addition to EGFR mutations, NSCLC patients carrying ALK\u002FROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformation(NET).\n\nIn a previous study \\[Pubmed ID: 35609408\\], the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments. This phenomenon could be under-recognized, because re-biopsy was less frequently performed in these patients. The investigators had also shown that p53\u002FRb inactivation might correlated with NET and should be considered for NET risk prediction. In another retrospective studies, it was found that NSCLC patients with RB1\u002FTP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1\u002FTP53 inactivation mutations (43 times higher than those without mutations). Therefore, the subgroup of NSCLC patients with tumor suppressor gene RB1\u002FTP53 dual inactivation might have elevated risk for NET.\n\nIn this study, the investigators proposed to prospectively follow up NSCLC patients with dual RB1\u002FTP53 inactivation (approximately 5% of the total NSCLC). Through prospective and systematic collection of baseline pathological information, clinical treatment process, and imaging data, and as much as possible, repeat pathological biopsies will be performed during disease progression.",[78,462,463],"Non-small Cell Lung Cancer","Histology Transformation",[465,466,467,468,469,470],"neuroendocrine transformation","small cell lung cancer transformation","TP53","RB1","histology transformation","non-small cell lung cancer","2024-04-22",{"date":473,"type":42},"2024-04-23",{"date":475,"type":42},"2021-01-01",{"date":477,"type":20},"2028-12-31",{"name":479,"class":113},"Fudan University"]