[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sclc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,53,132,165,190,222,249,280,303,325,350,380,401,422,448,477,502,528],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100575356","phase-1-slv-154-treatment-of-metastatic-solid-tumors-100575356",false,"NCT06771219","SLV-154 Treatment of Metastatic Solid Tumors","A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Men or women (as appropriate for cancer type) of age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n3. Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the following:\n\n   1. SCCHN\n   2. NSCLC\n   3. SCLC\n   4. Breast cancer\n   5. Cervical cancer\n   6. Endometrial cancer\n   7. Ovarian cancer\n   8. Urothelial cancer\n   9. Sarcoma\n   10. Thyroid cancer\n4. Presence of metastatic disease that has progressed during or following previous treatment.\n5. Presence of radiographically measurable disease.\n6. Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication.\n7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.\n8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and\u002For fluorodeoxyglucose (FDG) positron emission tomography (PET)\u002FCT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.\n9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.\n10. Adequate hematological profile.\n11. Adequate coagulation profile.\n12. Adequate hepatic profile.\n13. Adequate renal function.\n14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.\n15. For female subjects of childbearing potential, a negative serum pregnancy test.\n16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.\n17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.\n18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy\u002Faspirations and\u002For radiographic studies), and study restrictions.\n19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n1. Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.\n2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.\n3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.\n4. Significant cardiovascular event or comorbidity.\n5. Significant screening ECG abnormalities.\n6. Pregnancy or breastfeeding.\n7. Major surgery within 4 weeks before the start of study therapy.\n8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.\n9. Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.\n10. Concurrent participation in another therapeutic or imaging clinical trial.\n11. Other conditions likely to interfere with a subject's ability to participate in the study.","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.",[26,27,28,29,30,31,32,33,34,35],"Squamous Cell Cancer of Head and Neck (SCCHN)","NSCLC","SCLC","Cervical Cancer Metastatic","Breast Cancer Metastatic","Endometrial Cancer","Ovarian Cancer","Urothelial Cancer","Sarcoma","Thyroid Cancer",[37,38,39],"metastatic solid tumors","metastatic cancer","solid tumor","RECRUITING","2026-06-29",{"date":43,"type":44},"2026-06-30","ACTUAL",{"date":46,"type":44},"2025-05-14",{"date":48,"type":20},"2027-04",{"name":50,"class":51},"Solve Therapeutics","INDUSTRY",10,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":93,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":62,"type":20},300,[23,64],"PHASE2","The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[67,68,69,70,71,32,31,72,73,74,75,76,77,78,79,80,81,27,82,28,83,84,85,86,87,88,89,90,91,92],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC (Non-small Cell Lung Cancer)","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-06-24",{"date":124,"type":44},"2026-06-26",{"date":126,"type":44},"2020-10-29",{"date":128,"type":20},"2027-12-31",{"name":130,"class":51},"PMV Pharmaceuticals, Inc",77,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":161,"locationsCount":164},"100632066","phase-1-68ga-pfd3-pet-imaging-for-the-diagnosis-and-evaluation-of-small-cell-lung-cancer-100632066","NCT07508852","68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer","Targeting Delta-like Ligand 3 (DLL3) With 68Ga-PFD3 PET\u002FCT for the Diagnosis and Assessment of Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Adults.\n* Histologically confirmed small cell lung cancer (SCLC).\n* At least one measurable lesion ≥1 cm in diameter (primary tumor, metastatic lesion, or involved lymph node) confirmed by standard imaging modalities.\n* Laboratory tests (complete blood count and biochemical analysis) completed within 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Breastfeeding.\n* Acute psychiatric disorders.\n* Inability to undergo PET scanning (e.g., due to claustrophobia, weight limits, or other medical contraindications).\n* Inability to complete the study procedures as anticipated.\n* Prior therapy targeting DLL3.",{"count":140,"type":20},30,[23,64],"This study aims to investigate and evaluate the safety and performance of a novel probe, PFD3, for the diagnosis and assessment of patients with small cell lung cancer (SCLC).",[28,144,145,79,80],"SCLC, Extensive Stage","SCLC, Limited Stage",[28,147,148,149,150,151,152,153,154],"small cell lung cancer","PET\u002FCT","PET","DLL3","Delta-like ligand 3","imaging","diagnosis","evaluation","2026-06-16",{"date":157,"type":44},"2026-06-18",{"date":159,"type":44},"2025-10-22",{"date":128,"type":20},{"name":162,"class":163},"Peking University First Hospital","OTHER",1,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":183,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":187,"locationsCount":189},"100634105","medical-access-program-for-ifinatamab-deruxtecan-in-3l-pretreated-extensive-stage-small-cell-lung-cancer-100634105","NCT07535359","Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer","Medical Access Program for Ifinatamab Deruxtecan (I-DXd, DS-7300a)","Patients are only eligible after signing the informed consent form and must meet all of the following criteria to be eligible for the Medical Access Program.\n\nInclusion Criteria:\n\n* The patient has at least one SCLC lesion that has not been previously irradiated.\n* The patient is aged ≥18 years or older.\n* The patient has histologically or cytologically documented ES-SCLC.\n* The patient had prior therapy with platinum-based chemotherapy and one additional treatment as systemic therapy for extensive-stage disease.\n* The patient has received prior treatment with a minimum of two previous lines of systemic therapy.\n* The patient has a documented radiological disease progression on or after the most recent systemic therapy.\n* The patient has an ECOG PS of 0-1.\n* The patient has a life expectancy of ≥3 months\n* The patient has adequate organ and bone marrow function as defined in the protocol within 7 days prior to Cycle 1 Day 1 of I-DXd treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to screening laboratory tests.\n* Male and female patients of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the program and for at least 8 months for females and 5 months for males after the last dose of I-DXd.\n* Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrolment.\n* Female patients agree to not donate, or retrieve for their own use, ova throughout the participation in the MAP and for 8 months following the last dose of I-DXd. Preservation of ova may be considered prior to enrolment in this program.\n* Male patients are surgically sterile or willing to use highly effective birth control throughout the participation in the MAP and for 5 months following the last dose of I DXd.\n* Male patients agree not to freeze or donate sperm throughout participation in the MAP and for 5 months following the last dose of I-DXd. Preservation of sperm may be considered prior to enrolment in this program.\n\nPatients who meet any of the following criteria will not be eligible for the Medical Access Program.\n\nExclusion Criteria:\n\n* The Patient is eligible for other treatment options or can enroll in an open clinical trial with patients with pre-treated ES-SCLC.\n* The patient has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.\n* The patient has been discontinued from an ADC that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.\n* The patient has had an inadequate washout period before randomization as defined in the protocol.\n* The patient has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n* The patient has experienced any of the following events within the past 6 months:\n\n  1. cerebrovascular accident, or\n  2. transient ischemic attack, or\n  3. another arterial thromboembolic event.\n* The patient has a clinically significant corneal disease.\n* The patient has uncontrolled or significant cardiovascular disease as defined in the protocol.\n* The patient has any history of ILD\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n* The patient has a clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses as defined in the protocol.\n* The patient is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma\u002FCOPD), topical steroids (for mild skin conditions), or intra-articular steroid injections.\n* The patient has a history of allogeneic bone marrow, stem cell, or solid organ transplant.\n* The patient has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline.\n* The patient has a history of hypersensitivity to the drug substances, inactive ingredients in the drug product, or severe hypersensitivity reactions to other monoclonal antibodies.\n* The patient has a documented ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n* The patient has active or uncontrolled hepatitis B or C infection.\n* The patient has an active, known, or suspected autoimmune disease. The following patients may be enrolled as an exception:\n\n  1. Type I diabetes mellitus, hypothyroidism only requiring hormone replacement\n  2. Skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or\n  3. Conditions not expected to recur in the absence of an external trigger.\n* The patient has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness\u002Fsocial situations, substance abuse) or other factors that, in the physician's opinion, make it undesirable for the patient to participate in the MAP or would jeopardize compliance with the protocol. Screening for chronic conditions is not required.\n* The patient has received a live vaccine within 30 days prior to the first dose of I-DXd.\n* Female patients who are pregnant, breastfeeding, or intend to become pregnant during the MAP.\n* The patient has active or uncontrolled human immunodeficiency virus (HIV) infection. Participants must be tested for HIV viral load before enrollment if acceptable by local regulations or independent review boards\u002FIndependent ethics committee.\n* The patient has active or uncontrolled hepatitis B virus (HBV) infection. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have an undetectable HBV viral load prior to enrolment.\n* The patient has active or uncontrolled hepatitis C virus (HCV) infection. Participants with a history of hepatitis C infection are eligible if the HCV viral load is undetectable in the absence of antiviral therapy during the previous 4 weeks.","EXPANDED_ACCESS","The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen), and for eligible patients who have no suitable treatment options and are not able to enter a clinical study.",[28,175],"Extensive-stage Small Cell Lung Cancer",[177,178,179,180,181,182],"Ifinatamab Deruxtecan","Medical Access Program","3L+ SCLC","DS7300a","I-DXd","Extensive-stage small cell lung cancer","AVAILABLE","2026-06-05",{"date":186,"type":44},"2026-06-09",{"name":188,"class":51},"Daiichi Sankyo",3,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":201,"conditions":202,"keywords":210,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":4},"100638863","phase-3-evaluate-bl-m14d1-plus-atezolizumab-vs-standard-of-care-in-first-line-extensive-stage-small-cell-lung-cancer-100638863","NCT07625644","Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer","A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)\n* Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.\n* At least one measurable lesion based on RECIST v1.1 per investigator assessment.\n* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.\n* Participants who have received prior topoisomerase inhibitor-based ADC therapy.\n* Participants with history of severe heart disease\n* Participants with active autoimmune diseases and inflammatory diseases,\n* Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":198,"type":20},550,[200],"PHASE3","The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).",[203,204,205,206,207,71,208,209],"Small Cell Lung Cancer Extensive Stage","Small-cell Lung Cancer","Small Cell Carcinoma","Sclc","SCLC,Extensive Stage","Lung Cancer Metastatic","Lung Cancer Stage IV",[150,211],"First Line","NOT_YET_RECRUITING","2026-05-28",{"date":215,"type":44},"2026-06-04",{"date":217,"type":20},"2026-06",{"date":219,"type":20},"2031-06",{"name":221,"class":51},"SystImmune Inc.",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":238,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100566595","phase-1-first-in-human-study-of-tub-030-in-patients-with-advanced-solid-tumors-100566595","NCT06657222","First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","A Multicenter FIH Dose Escalation and Optimization Phase I\u002FIIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female aged 18 years or older\n2. Adequate organ function\n3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1\n4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.\n5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.\n6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.\n7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.\n8. Eastern Cooperative Oncology Group (ECOG) 0-1.\n9. Have a life expectancy of \\>12 weeks for disease-related mortality, as evaluated by the INV.\n10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent\n11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n\\-",{"count":230,"type":20},250,[23,64],"The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:\n\nTo determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.\n\nParticipants will:\n\nReceive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms",[234,235,28,27,236,237],"Advanced Solid Tumors","HNSCC","TNBC - Triple-Negative Breast Cancer","CRC",[234,27,77],"2026-05-22",{"date":241,"type":44},"2026-05-27",{"date":243,"type":44},"2024-12-13",{"date":245,"type":20},"2028-12",{"name":247,"class":51},"Tubulis GmbH",16,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100508643","phase-2-monalizumab-in-combination-with-durvalumab-medi4736-for-trreatment-of-small-cell-lung-cancer-100508643","NCT05903092","MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer","A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) for tReatmenT of Small Cell Lung Cancer (MOZART)","MOZART","General Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. Note: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. Demonstrate adequate organ function. All screening labs to be obtained within 28 days prior to registration.\n\n   * Absolute Neutrophil Count (ANC) \\> 1500mm\\^3\n   * Hemoglobin ≥ 9 g\u002FdL\n   * Platelet Count (PLT) ≥ 100,000 per mm3\n   * Calculated creatinine clearance ≥ 40 mL\u002Fmin\n   * Bilirubin ≤ 1.5 × upper limit of normal (ULN); subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), may be allowed with sponsor-investigator approval.\n   * Apsartate aminotransferase (AST) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n   * Alanine aminotransferase (ALT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n4. Females of childbearing potential must have a negative serum pregnancy test at screening.\n5. Females of childbearing potential and male subjects must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception.\n6. Life expectancy of ≥ 12 weeks.\n7. Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable through PCR to be eligible for this trial. Testing is not required for screening unless mandated by local authorities. Local guidelines for testing should be followed.\n\nExtensive Stage Specific Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of small cell lung cancer:\n\n   \\- Extensive disease (American Joint Committee on Cancer Stage (8th edition) IV SCLC \\[T any, N any, M1 a\u002Fb\\]), OR T3-4 disease due to multiple lung nodules that are too extensive or have tumor\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n2. No prior systemic therapy for small-cell lung cancer, with the following exceptions: Up to one cycle of platinum doublet chemotherapy with or without durvalumab is allowed up to 4 weeks prior to registration on this study. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and monalizumab may be included only after consultation with the sponsor-investigator. Patients should not have received Trilaciclib.\n3. Measurable disease according to RECIST v1.1.\n4. Subjects with treated brain metastasis or untreated asymptomatic brain metastasis that is clinically stable per investigator discretion and not requiring systemic steroids for ≥ 7 days. NOTE: Prophylactic cranial radiation (PCI) is allowed per investigator's discretion.\n5. ECOG Performance Status of 0-2.\n\nLimited Stage Specific Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of small cell lung cancer:\n\n   \\- Limited-stage disease (American Joint Committee on Cancer Stage (8th edition) I-III SCLC \\[T any, N any, M0\\])\n2. Has received platinum (cis- or carboplatin) and etoposide chemotherapy (4 cycles preferred; 3 cycles allowed if disease control is achieved and no additional benefit is expected with an additional cycle of chemotherapy in the opinion of the investigator) administered concurrently with radiation (60-66Gy daily or 45Gy BID). Radiation should have started no later than end of cycle 2 of chemotherapy.\n3. Non-progressive disease following completion of chemo-radiation.\n4. No evidence of brain metastasis. NOTE: PCI is allowed per investigator's discretion.\n5. Ability to start study treatment within 56 days of completing chemo-radiation, counting from whichever ends later\n6. ECOG Performance Status of 0-1.\n\nExclusion Criteria:\n\n1. Body weight ≤ 40 kg.\n2. Active infection requiring intravenous antibiotic therapy.\n3. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n4. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.\n5. History of active primary immunodeficiency.\n6. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n7. Presence of neurologic paraneoplastic syndrome.\n8. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., ulcerative colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis, Wegener syndrome \\[granulomatosis with polyangiitis\\], rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:\n\n   * Patients with vitiligo or alopecia\n   * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n   * Any chronic skin condition that does not require systemic therapy\n   * Patients without active disease in the last 2 years may be included but only after consultation with the study physician\n   * Patients with celiac disease controlled by diet alone\n9. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. NOTE: Subjects, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment.\n10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n11. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n12. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per investigator discretion.\n13. History of leptomeningeal carcinomatosis.\n14. History of allogeneic organ transplantation.\n15. Treatment with any investigational drug within 28 days prior to registration or concurrent enrolment in another clinical study, unless observational in nature.\n16. Current or prior use of immunosuppressive medication within 7 days before the first dose of monalizumab and durvalumab (applicable to 'on study' durvalumab for MOZART-ES cohort who may have received prior one dose of durvalumab). The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication), and for prevention of chemotherapy induced nausea\u002Fvomiting per institutional standards.\n17. Specific for MOZART-ES cohort: Patients who have received prior one dose of durvalumab along with chemotherapy:\n\n    * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n    * Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.",{"count":258,"type":20},84,[64],"This study has 2 cohorts: MOZART-ES cohort (for extensive-stage SCLC) and MOZART-LS cohort (for limited-stage SCLC).\n\nMOZART-ES cohort: Study treatment will consist of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide plus durvalumab plus monalizumab every 3 weeks for 4 cycles. After 4 cycles, subjects will continue maintenance treatment with durvalumab plus monalizumab every 4 weeks until disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal of consent. Patients who have received one prior cycle of treatment before enrolling on the study will receive a total of 4 cycles with monalizumab, durvalumab, and chemotherapy. There will be a safety lead-in phase, including 6 to 12 patients, to confirm the safety of the proposed dose of monalizumab to use in combination with chemotherapy and durvalumab.\n\nMOZART-LS cohort: Study treatment will consist of durvalumab and monalizumab following standard of care chemo-radiation consisting of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide for 3-4 cycles and standard dose radiation. Radiation therapy should have started before completion of cycle 2 of chemotherapy. NOTE: Subjects who have non-progressive disease and meet the eligibility criteria can start study treatment up to 56 days from completion of chemo-radiation. Durvalumab and monalizumab will be administered every 4 weeks for up to 2 years (26 cycles), disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal consent, whichever occurs first.",[79,28,262,263],"Extensive Stage Small Cell Lung Cancer","Limited Stage Small-Cell Lung Cancer",[265,266,267,268,269],"Small cell lung cancer","First-line therapy","Chemoimmunotherapy","Immunotherapy","Monalizumab","2026-04-24",{"date":272,"type":44},"2026-04-29",{"date":274,"type":44},"2023-09-26",{"date":276,"type":20},"2030-10-31",{"name":278,"class":163},"Hirva Mamdani",4,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100624981","phase-1-a-phase-i-clinical-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-hlx3901-in-patients-with-advanced-sclc-or-nec-100624981","NCT07416695","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 (DLL3 × DLL3 × CD3 × CD28 Tetra-specific Antibody) in Patients With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma","Inclusion Criteria:\n\n1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;\n2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;\n3. Histologically or cytologically confirmed advanced small cell lung cancer or neuroendocrine carcinoma; patients with advanced small cell lung cancer must have experienced intolerance, recurrence, or disease progression following prior treatment with a platinum-based therapy combined with immune checkpoint inhibitors, while patients with neuroendocrine carcinoma must have experienced intolerance, recurrence, or disease progression following prior platinum-based therapy; allowed histological subtypes include combined small cell lung cancer and mixed neuroendocrine-non-neuroendocrine neoplasms.\n4. At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to the first administration;\n5. An ECOG performance status score of 0-1 within 7 days prior to the first administration;\n6. Expected survival \\> 3 months;\n7. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 28 days from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological product therapy; at least 14 days from the previous small molecule targeted drug therapy and previous hormone therapy; at least 7 days from the previous administration of the traditional Chinese medicine for anti-tumor indications or minor surgery; recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v6.0, except for alopecia);\n8. Participants who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for DLL3 expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) collected from non-radiotherapy sites during the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens shall also be provided.\n9. Adequate organ function as confirmed by laboratory tests within 7 days prior to the first administration of the investigational product, with no therapies such as blood transfusion, albumin infusion, renal replacement therapy, granulocyte colony-stimulating factor (G-CSF), thrombopoietin, or erythropoietin administered within 14 days prior to the first administration:\n10. Male and female participants with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female participants of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. History of other malignant tumors within 2 years prior to the first administration, except cured cervical carcinoma in situ or cutaneous basal cell carcinoma;\n2. Presence of Grade ≥ 2 immune-related pneumonitis or immune-related myocarditis, or severe, life-threatening immune-mediated AEs or infusion-related reactions, including those leading to permanent discontinuation, when receiving previous anti-tumor immunotherapy;\n3. History or presence of clinically significant pulmonary impairment due to concurrent lung disease, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sicca syndrome, and sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within the past 6 months;\n4. With central nervous system diseases within 12 months prior to enrollment, such as seizures, cerebral hemorrhage, paralysis, aphasia, cerebral infarction (except for old cerebral infarction), severe brain injury, dementia, Parkinson's disease, cerebellar disease, mental illness, or any autoimmune disease involving the central nervous system;\n5. Active paraneoplastic syndrome;\n6. History of hypophysitis or pituitary dysfunction;\n7. Presence of uncontrolled third-space effusions (e.g., massive pleural effusion, ascites, or pericardial effusion) requiring repeated drainage and considered by the investigator to be unsuitable for enrollment;\n8. Prior allogeneic stem cell or solid organ transplantation;\n9. Prior exposure to any of the following: (1) combination or sequential therapy targeting DLL3, CD3, or CD28; (2) treatment with antibody-drug conjugates (ADCs); (3) major surgery, chemotherapy, biologic therapy, endocrine therapy, or macromolecular targeted therapy within 4 weeks prior to the first administration. Traditional Chinese medicine and small molecule targeted therapy with anti-tumor indications ≤ 2 weeks from the first administration of the investigational product;\n10. Known history of severe allergic reactions, anaphylactoid reactions, or other hypersensitivity reactions to humanized antibodies or fusion proteins, severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, or allergy to components of the investigational product preparations;\n11. Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;\n12. Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after active treatment);\n13. Active central nervous system (CNS) metastases and\u002For carcinomatous meningitis known or diagnosed at screening. However, the following participants are allowed to be enrolled: 1) Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no requirement for corticosteroids, and lesion size ≤ 1.5 cm) may be included, but are required to receive regular brain imaging as a site of disease. 2) Participants with treated brain metastases that have been stable for at least 2 months (confirmed by 2 imaging assessments at least 4 weeks apart following brain metastasis treatment), with no evidence of new or enlarging brain metastases and discontinued steroids at least 3 days prior to administration (stable brain metastases here should be confirmed before the first administration of the investigational product).\n14. Patients with known active or suspected autoimmune diseases. Patients with autoimmune-related hypothyroidism who are receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;\n15. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent dose of a similar drug) or other immunosuppressive agents within 14 days prior to the first administration; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; those with short-term use of corticosteroids for prophylaxis if a contrast agent is used;\n16. Patients with active tuberculosis;\n17. Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;\n18. Patients with active HBV or HCV infection or HBV\u002FHCV co-infection; Note: Patients who are HBsAg (+) and\u002For HBcAb (+) must undergo an HBV-DNA test and have a result \\\u003C 500 IU\u002FmL, \\\u003C 2500 copies\u002FmL, or \\\u003C ULN to be enrolled. Enrolled participants with detectable HBV-DNA must consent to receive antiviral nucleoside\u002Fnucleotide therapy.\n\n    If HCV antibody (+), HCV-RNA must be tested, and the result must be \\\u003C ULN for the participant to be eligible.\n\n    Participants with HBV\u002FHCV co-infection shall be excluded (positive for HBsAg or HBcAb and positive for HCV antibody).\n19. Have received live vaccines within 28 days prior to the first administration;\n20. Pregnant or lactating women;\n21. Participants who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.","75 Years",{"count":289,"type":20},138,[23],"This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.",[28,293],"NEC","2026-04-23",{"date":272,"type":44},{"date":297,"type":44},"2026-04-17",{"date":299,"type":20},"2029-06-30",{"name":301,"class":51},"Shanghai Henlius Biotech",2,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":21,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100529845","phase-1-a-study-of-zl-1310-in-subjects-with-small-cell-lung-cancer-100529845","NCT06179069","A Study of ZL-1310 in Subjects With Small Cell Lung Cancer","An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Participants With Small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed informed consent\n* Participant with metastatic or extensive-stage small cell lung cancer (de novo, not transformed) and for Part 1A and 1B must have documented disease progression during or following a platinum-based chemotherapy regimen. For Part 1C and Part 4, no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC). For Part 1B backfill and Part 3, first-line setting: no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC); or, first-line maintenance setting: participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin, etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. For Part 2-1, participants must have received no more than 2 lines of prior therapies in the extensive-stage setting, and progressed on or after a platinum-based chemotherapy regimen AND an anti-DLL3 T-cell engager (TCE). For Part 3, participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator.\n* Adult men and women ≥18 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subjects must have at least one measurable target lesion as defined by RECIST v1.1 on CT, PET\u002FCT, or MRI.\n* Subjects must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample at screening per protocol guidelines.\n* Life Expectancy \\>\u002F= 3 months.\n\nExclusion Criteria:\n\n* Participants with another known malignancy that is progressing or requires active treatment within the last 2 years. Exceptions: basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin with previously administered curative treatment, in situ cervical cancer, or other cancers that do not require systemic anti-cancer therapies and will not impact life expectancy.\n* Symptomatic or untreated brain metastasis requiring concurrent treatment. For Part 2, Part 3, and Part 4 the following subjects can be enrolled if they have a stable neurologic status for at least 2 weeks prior to the first dose of ZL-1310:\n\n  1. Subjects with untreated and asymptomatic brain metastases.\n  2. Subjects with treated brain metastases that are no longer symptomatic (i.e. without neurologic signs or symptoms), who require no treatment with steriods or anticonvulsants and have recovered from the actue toxic effects of radiotherapy.\n* Subjects with leptomeningeal disease.\n* Treatment with any systemic anti-cancer treatment or other investigational products\u002F device within 3 weeks before first dose of study treatment.\n* Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or have had a history of radiation pneumonitis.\n* Major surgery within 4 weeks of the first dose of study treatment.\n* Hypersensitivity to any ingredient of the study treatment.\n* Inadequate organ function (as defined in protocol) within 10 days prior to the first dose of study treatment,\n* Participants with a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer.\n* Participants have received a live or live-attenuated vaccine within 30 days of planned start of study therapy.\n* Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment\n* Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders, including but not limited to pneumonitis.\n* Pregnant or nursing (lactating) women.\n* Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first study treatment, whichever is longer.\n* For Part 1C and Part 4 (ZL-1310 in combination with Atezolizumab and Carboplatin), participants who received prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies.\n* For Part 1B (ZL-1310 in combination with Atezolizumab) and Part 1C (ZL-1310 in combination with Atezolizumab and Carboplatin), participants who received systemic immunostimulatory agents (including but not limited to, IFNs and IL2) within 4 weeks or 5 drug-elimination half-lives, whichever is longer, prior to the initiation of study treatment.",{"count":311,"type":20},339,[23],"An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer",[28],"2026-03-30",{"date":317,"type":44},"2026-04-03",{"date":319,"type":44},"2024-01-23",{"date":321,"type":20},"2027-07-31",{"name":323,"class":51},"Zai Lab (Shanghai) Co., Ltd.",38,{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":21,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":302},"100601408","phase-2-golidocitinib-with-pd-1-inhibitors-as-maintenance-treatment-for-previously-untreated-es-sclc-100601408","NCT07110103","Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC","Golidocitinib With PD-1 Inhibitors as Maintenance Treatment in Patients With Previously Untreated Extensive-stage Small Cell Lung Cancer: an Open-label, Single-arm, Phase 2 Study","JACKPOT38","Inclusion Criteria:\n\n1. Able to provide a signed and dated informed consent form, including compliance with the requirements and restrictions listed in the ICF and this protocol;\n2. Subjects are ≥ 18 years old when signing the ICF;\n3. Subjects have an ECOG performance status score of 0 or 1 and have not deteriorated in the past 2 weeks;\n4. Life expectancy ≥ 3 months;\n5. Histologically or cytologically confirmed ES-SCLC (stage IV \\[any T stage, any N stage, M1 a\u002Fb\u002Fc stage\\] according to the 8th edition of the AJCC TNM staging system for lung cancer, or T3-4 stage disease caused by multiple lung nodules and the disease is too diffuse, or the tumor\u002Fnodule volume is too large to be tolerated by a tolerable radiotherapy plan);\n6. The presence of at least one measurable lesion (based on RECIST 1.1): with a long diameter ≥ 10 mm (lymph node lesions require a short diameter of ≥15 mm) that can be accurately and repeatedly measured at baseline under CT or MRI; and there are measurable lesions outside the central nervous system;\n7. SCLC patients who have not received any systemic anti-tumor treatment for advanced disease; if the patient has received neoadjuvant\u002Fadjuvant therapy in the past, the interval between the diagnosis of ES-SCLC and the completion of the last treatment must be at least 6 months;\n8. Patients must be suitable for platinum (cisplatin or carboplatin)-based chemotherapy as the first-line treatment for ES-SCLC;\n9. Adequate bone marrow reserve and organ system function reserve, summarized as follows:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL without growth factor support;\n   * Platelet ≥ 100×109\u002FL without growth factor support or blood transfusion;\n   * Hemoglobin ≥ 9 g\u002FdL or 90 g\u002FL without erythropoietin or blood transfusion;\n   * Total bilirubin ≤ 1.5 × ULN; if suffering from Gilbert syndrome (unconjugated hyperbilirubinemia), total bilirubin should be ≤ 3 × ULN;\n   * ALT and AST ≤ 2.5 × ULN. For patients with documented liver metastases, AST and ALT levels ≤ 5 × ULN;\n   * Creatinine clearance calculated by the Cockcroft-Gault method, \\>60 ml\u002Fmin for patients receiving cisplatin and \\>45 ml\u002Fmin for patients receiving carboplatin;\n   * Urine routine examination shows less than 2+ protein in urine, or 24-hour urine protein quantitative \\\u003C1 g;\n   * Good coagulation function, defined as international normalized ratio (INR) and\u002For prothrombin time (PT) ≤1.5 times ULN and\u002For activated partial thromboplastin time (APTT) ≤1.5 upper limit of normal; if the subject is receiving anticoagulant therapy, as long as the PT is within the intended use range of the anticoagulant drug;\n   * Serum amylase ≤1.5 times ULN and\u002For serum lipase ≤1.5 times ULN;\n   * Left ventricular ejection fraction (LVEF) ≥ 55%;\n10. For patients with central nervous system metastases, the following conditions must be met before they can be included:\n\n    * No neurological symptoms or symptoms are stable for at least 2 weeks after local treatment, no need to use corticosteroids or anti-epileptic drugs, and hormonal treatment has been stopped within 3 days before the first dose of study drug;\n    * If brain metastases have been treated locally (radiotherapy or surgery), there should be a time window of ≥ 2 weeks before the first dose of study treatment to ensure that local treatment-related adverse events have been reduced to CTCAE ≤ 1 grade;\n11. Women of childbearing potential must undergo a urine and\u002For serum pregnancy test (if the urine test cannot be confirmed as negative) within 7 days before the first medication, and the result must be negative; WOCBP or men and their WOCBP partners should agree to take effective contraceptive measures from the signing of the ICF until 6 months after the last dose of the study drug;\n12. The subjects should be able to understand the study protocol and voluntarily comply with the study and follow-up;\n13. For patients who are about to enter the maintenance period, the investigator shall determine whether they are suitable for starting treatment with golidocitinib combined with PD-1 inhibitors (generally all previous toxicities must be alleviated to CTCAE ≤ 1 level, excluding hair loss, fatigue or other conditions that are judged by the investigator to be clinically insignificant).\n\nExclusion Criteria:\n\n1. Histopathological confirmation of the presence of mixed NSCLC and SCLC components;\n2. The presence of spinal cord compression or meningeal metastasis;\n3. Any of the following medical histories:\n\n   * Systemic treatment with Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for the control of pleural effusion) within 2 weeks before the first dose;\n   * Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first dose; any drug still in the development stage needs to be washed out for 5 half-lives (or discussed with the research team);\n   * Other major surgeries other than diagnosis or biopsy (excluding vascular access) within 4 weeks before the first dose, or major surgery is expected during the study;\n   * Palliative radiotherapy within 2 weeks before the first dose;\n   * Serious arterial\u002Fvenous thrombotic events, including cerebrovascular accident (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first dose;\n   * Currently receiving (or unable to stop taking at least 1 week before the first dose) drugs, herbal supplements, and foods that are known to be strong inducers or inhibitors of CYP3A;\n   * Prior to the first dose, there was a CTCAE caused by previous treatment \\> Grade 1 adverse events (except alopecia of any degree);\n4. Receiving solid organ or blood system transplantation (such as previous allogeneic bone marrow transplantation or whole blood transfusion within 120 days of sample collection during the study);\n5. Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid hormone treatment, or current clinically active interstitial lung disease (including interstitial lung changes), immune pneumonitis caused by immunotherapy;\n6. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment;\n7. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) are allowed;\n8. Diagnosed with other malignancies within 5 years before the first dose, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been evaluated to be clinically cured;\n9. Vaccinated with live vaccines within 30 days before the first dose (cycle 1, day 1), including live attenuated vaccines, excluding inactivated vaccines;\n10. Known active tuberculosis, such as positive tuberculin (PPD) test (nodule diameter \\> 10 mm), positive T-SPOT test, chest X-ray\u002FCT Tuberculosis lesions are found, or other positive results are found based on routine clinical screening (except for those who have been cured after standardized anti-tuberculosis treatment as assessed by the researchers);\n11. Subjects currently have severe infectious diseases that are difficult to control and must be excluded. After the recent infectious diseases are under control, the research team must determine whether they can be included in the group;\n12. Subjects with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and COVID-19 active infections (determined by the researchers to be clinically significant, with signs or symptoms, etc.). Testing for COVID-19 will be based on local practice;\n13. Meet any of the following cardiac criteria:\n\n    * Congestive heart failure (CHF) classified as class II by the New York Heart Association (NYHA);\n    * Clinically significant valvular heart disease, hypertrophic or constrictive cardiomyopathy;\n    * Any clinically significant abnormalities on resting ECG, such as complete left bundle branch block, 2\u002F3 degree atrioventricular block, PR interval \\> 250 msec;\n    * Average calibrated QTcF \\> 470 msec of 3 resting ECGs during the screening period;\n    * Subjects with any factors that may cause QT prolongation or increased risk of arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome or a first-degree relative with long QT syndrome or a family history of unexplained sudden death under the age of 40, or any concomitant medication known to cause QT prolongation);\n    * Ventricular arrhythmias requiring treatment;\n    * Acute myocardial infarction (AMI), unstable angina or new angina within 6 months before the administration of this study;\n14. Allergy to the drugs used in the study or their ingredients;\n15. Intractable nausea and vomiting, chronic gastrointestinal diseases, difficulty swallowing drugs, intestinal obstruction or previous intestinal resection, which may lead to inability to fully absorb the study drugs;\n16. Pregnant or lactating women;\n17. Known bleeding diathesis, that is, hemophilia, von Willebrand disease;\n18. The investigators assess that there are severe or uncontrollable systemic diseases (including poorly controlled hypertension and bleeding diseases) that cannot be carried out in clinical studies or may lead to poor compliance with clinical studies.",{"count":334,"type":20},20,[64],"This is an open-label, single-arm, phase 2 study to evaluate the safety and efficacy of golidocitinib with PD-1 inhibitors as maintenance treatment in patients with previously untreated extensive-stage small cell lung cancer.",[28,144],[339,340],"golidocitinib","ES-SCLC","2026-02-25",{"date":343,"type":44},"2026-02-27",{"date":345,"type":44},"2025-10-31",{"date":347,"type":20},"2028-06-30",{"name":349,"class":163},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":21,"phases":359,"briefSummary":360,"conditions":361,"keywords":368,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":164},"100415211","phase-1-a-first-in-human-jab-8263-in-adult-patients-with-advanced-tumors-100415211","NCT04686682","A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors","A Phase I\u002FIIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n* Subjects must meet all the following criteria in order to be included in the research study:\n\n  1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).\n  2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n  3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.\n  4. Subjects with recurrent\u002Frefractory AML according to WHO 2016\n  5. Subjects with life expectancy ≥3 months.\n  6. Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.\n  7. Patients who have sufficient baseline organ function.\n\nExclusion Criteria:\n\n1. History (≤3 years) of cancer that is histologically distinct from the cancer under study.\n2. Known serious allergy to investigational drug or excipients\n3. Active brain or spinal metastases\n4. History of pericarditis or Grade ≥2 pericardial effusion\n5. History of interstitial lung disease.\n6. History of Grade ≥2 active infections within 2 weeks\n7. Known human immunodeficiency virus (HIV) infection\n8. Seropositive for hepatitis B virus (HBV)\n9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.\n10. Any severe and\u002For uncontrolled medical conditions\n11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident\n12. Impaired cardiac function or clinically significant cardiac diseases\n13. QTcF \\>470 msec at screening\n14. History of medically significant thromboembolic events or bleeding diathesis\n15. Unresolved Grade \\>1 toxicity\n16. History of malignant biliary obstruction\n17. Pregnant or breast-feeding",{"count":358,"type":20},152,[23,64],"This is a Phase 1\u002F2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study.\n\nThese two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled.",[27,28,362,363,364,365,366,367],"CRPC","ESCC","Ovarian Carcinoma","AML","MF","Malignant Tumor",[369,370],"BET inhibitor","Bromodomain and Extra-terminal","2026-01-08",{"date":373,"type":44},"2026-01-09",{"date":375,"type":44},"2021-05-07",{"date":377,"type":20},"2028-07",{"name":379,"class":51},"Jacobio Pharmaceuticals Co., Ltd.",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":387,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":389,"phases":4,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":164},"100517741","observational-study-to-evaluate-the-safety-and-efficacy-of-zepzelca-injection-100517741","NCT06021483","Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection","Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice","Inclusion Criteria:\n\n* Patients who voluntarily provide written consent for personal information collection and utilization after receiving an explanation about the objective and methods of the study\n* Patients who have received or are scheduled to receive Zepzelca™ inj., according to domestic approval indications\n* Patients with metastatic SCLC who have failed first-line platinum-based chemotherapy\n\nExclusion Criteria:\n\n* Patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment\n* Patients with a history of hypersensitivity reactions to this drug or its components\n* Pregnant, potentially pregnant, or lactating women\n* Patients currently participating in another clinical trial (drug or medical device) or planning to participate in another clinical trial during the study period (except for non-interventional clinical studies or cases where the clinical trial drug administration has ended and only follow-up is remaining)\n* Patients who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.","19 Years",{"count":62,"type":20},"OBSERVATIONAL","The purpose of this study is to evaluate the safety and efficacy of Zepzelca™ inj. in real-world practice and to investigate important identified risks and gaps in information related to risk management plans.",[28],"2025-09-14",{"date":394,"type":44},"2025-09-16",{"date":396,"type":44},"2023-08-16",{"date":398,"type":20},"2025-09",{"name":400,"class":51},"Boryung Pharmaceutical Co., Ltd",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":287,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":420,"locationsCount":302},"100579166","phase-2-irinotecan-liposomeii-combined-with-ivonescimab-as-second-line-treatment-for-small-cell-lung-cancer--a-prospective-single-arm-multicenter-clinical-study-100579166","NCT06820762","Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically or cytologically confirmed SCLC;\n3. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;\n4. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;\n5. Life expectancy of ≥3 months;\n6. At least one measurable lesion is present according to the efficacy evaluation criteria for RECIST 1.1（Lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions）\n7. No untreated central nervous system (CNS) metastases or CNS were stable for ≥1 month after treatment\n8. Have adequate organ function;\n9. All female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug.\n10. Able and willing to provide a written informed consent;\n\nExclusion Criteria:\n\n1. Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients\n2. History of severe active autoimmune disease\n3. Participated in other drug studies within 4 weeks before enrollment\n4. Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk\n5. History of major illness within 1 year before the first medication\n6. History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration\n7. History of surgery or severe trauma within 4 weeks prior to initial dosing\n8. Evidence and history of severe bleeding tendency;\n9. Participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment\n10. Patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n11. History of alcohol abuse, psychotropic substance abuse or drug abuse. Other conditions considered unsuitable for this study by the investigator.",{"count":408,"type":20},40,[64],"This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.",[28],[413],"SCLC，irinotecan liposome(II)，Ivonescimab","2025-02-05",{"date":416,"type":44},"2025-02-11",{"date":418,"type":20},"2025-02-28",{"date":128,"type":20},{"name":421,"class":163},"The Second Affiliated Hospital of Dalian Medical University",{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":389,"phases":4,"briefSummary":431,"conditions":432,"keywords":434,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":164},"100571985","cognitive-screening-in-lung-cancer-patients-100571985","NCT06727370","Cognitive Screening in Lung Cancer Patients","Inclusion Criteria:\n\n* Small-cell and non-small-cell lung cancer (stage I, II, III, IV)\n* Age ≥ 18 years\n* Patients able to speak and read the local language(s) fluently\n* Acceptance and signature of informed consent\n\nExclusion Criteria:\n\n* Age ≥ 70\n* Presence of brain metastases\n* Patients with concomitant neurological or psychiatric disorders.\n* Patients undergoing brain radiotherapy\n* Previous diagnosis of lung cancer","70 Years",{"count":430,"type":20},200,"This study aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both NSCLC and SCLC. The primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive neuropsychological assessment.",[433,82,28],"Lung Disease",[435,436,437,438],"lung cancer","nsclc","sclc","cognitive","2024-12-06",{"date":441,"type":44},"2024-12-10",{"date":443,"type":44},"2024-01-10",{"date":445,"type":20},"2025-12-31",{"name":447,"class":163},"European Institute of Oncology",{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":455,"enrollmentInfo":456,"targetDuration":4,"studyType":21,"phases":458,"briefSummary":459,"conditions":460,"keywords":464,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":164},"100557180","phase-2-milaberon-in-advanced-solid-tumors-an-open-multicenter-clinical-study-100557180","NCT06534762","Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study","Efficacy and Safety of Milaberon in Combination With Standard Therapy in Advanced Solid Tumors: an Open, Multicenter, Clinical Study","Inclusion Criteria:\n\n* Patients voluntarily participate in the study, sign informed consent, and have good compliance;\n* 18-65 years old (including 18 and 65 years old);\n* solid tumors confirmed by histology and\u002For cytology, and advanced metastatic tumors that are not feasible for surgical resection;\n* Has not received previous systemic antitumor drug therapy for metastatic\u002Frecurrent solid tumors;\n* For subjects who have previously received neoadjuvant\u002Fadjuvant therapy, it takes more than 6 months from the last treatment to relapse or progression;\n* Recovery of previous treatment-related AEs to National Cancer Institute Terminology Criteria for Common Adverse Events (NCI-CTCAE)≤ Grade 1 (excluding alopecia);\n* According to RECIST 1.1 standard, there is at least one measurable lesion assessed by the research center, and the measurable lesion should be a lesion that has not received local treatment such as radiotherapy (the lesion located in the region of previous radiotherapy can also be regarded as a measurable lesion that meets the requirements if progress is confirmed);\n* ECOG physical condition: 0-1;\n* Expected survival ≥ 12 weeks;\n* The function of major organs is normal, I .e. the following criteria are met (no blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor \\[CSF\\] treatment has been received within 14 days before the first study drug administration): blood test (absolute value of neutrophils ≥ 1.5 × 109\u002FL, platelets ≥ 100 × 109\u002FL, hemoglobin concentration ≥ 9g\u002FdL); Liver function test (bilirubin ≤ 1.5 × ULN; aspartate aminotransferase and glutamate aminotransferase ≤ 2.5 ×ULN, AST and ALT ≤ 5 ×ULN in case of liver metastasis); renal function (serum creatinine ≤ 1.5 ×ULN, or creatinine clearance rate (CCr)≥ 60 ml\u002Fmin); coagulation function, international normalized ratio (INR)≤ 1.5 ×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤ 1.5 ×ULN; thyroid function, thyroid-stimulating hormone (TSH)≤ the upper limit of normal (ULN); FT3 and FT4 levels should be examined if abnormal, and FT3 and FT4 levels are normal; (11) Women of childbearing age must have a negative serum pregnancy test within 14 days prior to treatment and be willing to use medically approved effective contraception during the study period and within 3 months after the last dose of study medication (e. g. IUDs, contraceptives or condoms; surgical sterilization is required for male subjects whose partner is a woman of childbearing age, alternatively, an effective method of contraception is recommended for the duration of the study and for 3 months after the last study dose.\n\nExclusion Criteria:\n\n* Received the following treatment within 4 weeks before treatment: radiotherapy of tumor, major surgical operation or wound has not been completely healed, β3 adrenoceptor agonist and corresponding clinical research drugs;\n* those who have contraindications to Miraberon: those who are allergic to Miraberon or any of its excipients;\n* Active malignant tumors in the past 3 years, except for tumors participating in the study and local tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc;\n* symptomatic brain or meningeal metastases; Severe infection (such as intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks before treatment, or fever of unknown origin\\> 38.5°C during screening\u002Ffirst dose;\n* have high blood pressure that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);\n* Within 3 months before treatment, there were obvious clinical bleeding symptoms or obvious bleeding tendency (bleeding\\> 30 mL within 3 months, hematemesis, black stool, hematochezia), hemoptysis (fresh blood\\> 5 mL within 4 weeks), etc. or a venous\u002Fvenous thrombotic event within 6 months prior to treatment, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; or the need for long-term anticoagulant therapy with warfarin or heparin, or the need for long-term antiplatelet therapy (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday);\n* The tumor is found to invade large vascular structures during screening, such as pulmonary artery, superior vena cava or inferior vena cava, and the researchers judge that there is a greater risk of bleeding;\n* Active heart disease, including myocardial infarction, severe\u002Funstable angina pectoris, 6 months before treatment. Echocardiography left ventricular ejection fraction \\\u003C50%, arrhythmia poorly controlled;\n* Uncontrollable pleural effusion, pericardial effusion or ascites requiring frequent drainage after appropriate intervention;\n* Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function progression, decreased thyroid function; Note:(1) Subjects whose thyroid function can only be controlled by hormone replacement therapy can be included;(2) Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, type 1 diabetes, or childhood asthma has been completely resolved, and no intervention can be included after adulthood;(3) Patients with asthma who require medical intervention with bronchodilators cannot be included;\n* received treatment with live attenuated vaccine within 28 days prior to the first administration of the study drug;\n* The patient has a known history of psychotropic substance abuse, alcohol abuse or drug abuse; a history of definite neurological or psychiatric disorders, including epilepsy or dementia\n* tuberculosis infection history;\n* known human immunodeficiency virus (HIV) infection;\n* Known history of clinically significant liver disease, including viral hepatitis \\[Known hepatitis B virus (HBV) carriers must exclude active HBV infection, I .e., HBV DNA positive (\\>1 × 104 copies\u002FmL or\\> 2000 IU\u002FmL);\n* Known hepatitis C virus infection (HCV) and HCV RNA positive (\\>1 x 103 copies\u002FmL), or other hepatitis, cirrhosis\\];\n* Patients with renal injury: GFR\\\u003C30 mL\u002Fmin 1.73m2 or patients requiring hemodialysis\n* any other medical condition, clinically significant metabolic, physical, or laboratory abnormality, which, in the investigator's judgment, would reasonably suspect that the patient has a disease or condition that is not appropriate for the study drug (e. g., having seizures requiring treatment, bladder outlet obstruction, anxiety), or would interfere with the interpretation of the study results, or place the patient in a high-risk situation, or patients considered by the investigator to be unsuitable for inclusion.","65 Years",{"count":457,"type":20},260,[64],"This study is an exploratory study, and all the drugs involved are listed drugs. The dosage of mirabetron is selected according to the basis of previous research. The clinical recommend dose of this product is 50mg\u002Fday, and the dose used in this study is 100mg\u002Fday, which is larger than the clinical commonly used dose. The main adverse reactions of this product are urinary tract infection and rapid heartbeat. In the clinical study, we will focus on the urine routine and heart-related adverse events of the subjects, and deal with the adverse events in time.\n\nSubjects were given mirabeeron 100mg\u002Fday orally once a day in the morning until disease progression. When there are related or possible related side effects of the study drug mirabeeron, and according to NCI-CTCAE V 5.0, when subjects have more than or equal to grade 3 related toxicity, the administration should be delayed until grade 2 or lower to baseline, and the dose will be reduced by 50%, and subsequent dose increase is not allowed. If the pre-dose criteria are not met within 28 days, the drug will be permanently discontinued.",[27,28,73,461,236,462,463],"Pancreas Cancer","DLBCL - Diffuse Large B Cell Lymphoma","Squamous Cell Carcinoma of Head and Neck",[71,461,74,465,73,466,467],"B cell lymphoma","Carcinoma of Head and Neck","Miraberon","2024-07-30",{"date":470,"type":44},"2024-08-02",{"date":472,"type":44},"2024-07-15",{"date":474,"type":20},"2028-07-01",{"name":476,"class":163},"Zhejiang Provincial People's Hospital",{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":287,"enrollmentInfo":484,"targetDuration":4,"studyType":21,"phases":486,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":164},"100552601","phase-2-adebrelimab--apatinib-in-sclc-maintenance-therapy-100552601","NCT06475209","Adebrelimab + Apatinib in SCLC Maintenance Therapy","Observational Study on the Efficacy and Safety of Adebrelimab Combined With Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent and good compliance for follow-up.\n2. Age between 18 and 75 years old.\n3. Histologically or cytologically confirmed extensive-stage small cell lung cancer (LS-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria.\n4. ECOG performance status score: 0 to 2.\n5. Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Atezolizumab induction therapy.\n6. Recovery of non-hematologic adverse reactions to grade 1 (except for alopecia, skin pigment changes, or as determined by the investigator) following induction therapy.\n7. Time from the end of induction treatment (last dose) to initiation of maintenance treatment ≤ 6 weeks.\n8. At least one measurable lesion assessed by the investigator according to RECIST 1.1.\n9. Expected life expectancy of at least 3 months.\n10. Normal function of major organs, meeting the following criteria:\n\n    * Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL (grade 1 according to CTCAE 5.0); platelets ≥ 100×10\\^9\u002FL; hemoglobin \\> 80g\u002FL.\n    * Renal function: Creatinine ≤ 1.5 times the upper limit of normal (ULN), grade 1 according to CTCAE. Note: If creatinine is greater than 1.5 times the ULN, creatinine clearance must be \\> 50ml\u002Fmin.\n    * Liver function: Bilirubin ≤ 1.5 times ULN (grade 1 according to CTCAE), patients with Gilbert's syndrome bilirubin ≤ 3.0 times ULN; AST and ALT ≤ 3.0×ULN.\n    * Coagulation indicators: International normalized ratio (INR) ≤ 1.55 (if the patient is receiving a stable dose of therapeutic warfarin or low molecular weight heparin, INR is usually between 2 and 3), PTT \\\u003C 1.2 times ULN.\n11. Women of childbearing potential must agree to use contraception during the study and for 6 months after the end of the study (such as an intrauterine device, contraceptive pills, or condoms); serum or urine pregnancy test must be negative within 1 week before enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n1. Limited-stage small cell lung cancer (SCLC).\n2. Histologically or cytologically confirmed mixed-type SCLC.\n3. Prior use of anti-angiogenic drugs or deemed unsuitable for anti-angiogenic therapy by the investigator.\n4. Central tumors invading major blood vessels with assessed bleeding risks.\n5. Factors affecting oral medication (e.g., dysphagia, chronic diarrhea, intestinal obstruction).\n6. Major surgical procedures, incisional biopsies, or significant traumatic injuries within 4 weeks prior to enrollment.\n7. Participation in another investigational drug clinical trial within the past 4 weeks.\n8. Medical history including:\n\n   * Untreated or symptomatic brain metastases or spinal cord compression.\n   * Concurrent active malignant tumors requiring treatment.\n   * History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.\n   * History of substance abuse disorders not amenable to treatment or psychiatric disorders.\n9. Presence of any severe and\u002For uncontrolled diseases including:\n\n   * Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).\n   * Ischemic heart disease or myocardial infarction of grade I or higher, arrhythmias (including QTc ≥ 450ms for males, QTc ≥ 470ms for females), and ≥ grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] functional classification); or left ventricular ejection fraction (LVEF) \\\u003C 50% based on echocardiography.\n   * Decompensated diabetes or other contraindications to high-dose corticosteroid therapy.\n   * Worsening chronic obstructive pulmonary disease (COPD) or other severe respiratory diseases requiring hospitalization.\n   * Active or uncontrolled severe infections (≥ CTC AE grade 2).\n   * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n   * Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral therapy.\n   * Renal insufficiency: Urine protein ≥ ++ on urinalysis, and confirmed 24-hour urine protein quantitation \\> 1.0 g.\n10. Clinically significant hemoptysis (\\>1\u002F2 teaspoon of fresh blood) or significant bleeding symptoms within the past 3 months prior to enrollment, or evidence of bleeding tendency such as gastrointestinal bleeding, bleeding gastric ulcers, baseline fecal occult blood test ≥ ++, or non-healed wounds, ulcers, or fractures.\n11. Occurrence of venous or arterial thrombotic events within the past 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhages, cerebral infarctions), deep vein thrombosis, and pulmonary embolism.\n12. Abnormal coagulation function (INR \\> 1.5 or prothrombin time PT \\> ULN + 4 seconds or APTT \\> 1.5 ULN), bleeding tendency, or undergoing thrombolysis or anticoagulant therapy. Use of low-dose heparin (adult daily dose of 0.6-1.2 x 104U) or low-dose aspirin (daily dose ≤ 100 mg) is permitted for prophylactic purposes with INR ≤ 1.5.\n13. Patients unable to comply with study procedures, restrictions, and requirements as judged by the investigator are ineligible for participation.",{"count":485,"type":20},60,[64],"This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design.\n\nThe study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.",[28],[28,490,491,492],"Adebrelimab","Apatinib","Maintenance Therapy","2024-06-25",{"date":495,"type":44},"2024-06-26",{"date":497,"type":20},"2024-06-20",{"date":499,"type":20},"2026-12-20",{"name":501,"class":163},"Tang-Du Hospital",{"id":503,"slug":504,"hasResults":11,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":28,"eligibilityCriteria":508,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":509,"enrollmentInfo":510,"targetDuration":4,"studyType":21,"phases":512,"briefSummary":513,"conditions":514,"keywords":516,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":4},"100549998","phase-3-toripalimab-plus-anlotinib-for-the-maintenance-of-extensive-stage-small-cell-100549998","NCT06441344","Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell","First-line Etoposide Combined With Platinum-based Chemotherapy Followed by Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell Carcinoma - A Randomized, Controlled, Multicenter Phase III Clinical Study","Inclusion Criteria:\n\n* Male or female aged ≥ 18 and\\\u003C80 years old.\n* The ECOG score is 0-1 points (including 0 and 1 points), and the expected survival period is not less than 3 months.\n* Confirmed as small cell lung cancer (SCLC) by histopathology or cytology and diagnosed as extensive after systemic evaluation.\n* I have not received first-line treatment for ES-SCLC systemic chemotherapy or immune checkpoint inhibitors in the past.\n* Limited stage SCLC progresses to extensive stage SCLC after receiving previous radiotherapy and chemotherapy aimed at cure,at least 6 months of no treatment period is required after the last radiotherapy and\u002For chemotherapy treatment.\n* Patients with previous active brain metastases have stabilized after treatment and do not require immediate or planned brain intervention during the study period Transfer for local treatment.\n* According to the criteria for evaluating the efficacy of solid tumors (RECIST v1.1), enrolled patients should have at least one tumor throughout their body The tumor lesion can meet the following requirements: it has not undergone local treatment such as radiotherapy in the past and is at baseline Can be accurately measured, with a baseline maximum diameter of ≥ 10mm (if it is a lymph node, a minimum diameter of ≥ 15mm is required).\n\nLesions that have previously received local treatment (radiotherapy or other treatments), if the treatment is completed for at least 6 months If disease progression occurs later, the lesion in the area that has undergone local treatment can be considered a measurable lesion.\n\n* Patients should have sufficient bone marrow reserve function and no liver, kidney, or coagulation dysfunction, and laboratory tests should be conducted\n* The value must meet the following conditions:\n\n  1. Absolute neutrophil count ≥ 1.5 × 109\u002FL, and white blood cell count ≥ 3 × 109\u002FL;\n  2. Platelet count ≥ 100 × 109\u002FL;\n  3. Hemoglobin ≥ 90g\u002FL;\n  4. Serum creatinine (Cr) ≤ 1.5 x Upper limit of normal (ULN) or creatinine clearance rate (CrCl) ≥ 50ml\u002Fmin (for patients with serum creatinine\\>1.5 x ULN);\n  5. If there is no confirmed liver metastasis, AST and ALT ≤ 2.5 × ULN; If there is confirmed liver metastasis, AST,ALT ≤ 5 × ULN;\n  6. If there is no confirmed liver metastasis, total bilirubin ≤ 1.5 × ULN; If there is confirmed liver metastasis or patients with syndrome (high indirect bilirubinemia), total bilirubin ≤ 3 x ULN;\n  7. If there is no confirmed liver metastasis, alkaline phosphatase (ALP) ≤ 2.5 x ULN or ≤ 5 x ULN (bone metastasis)\n  8. Albumin (ALB)\\>30g\u002Fdl;\n  9. 24-hour urine protein quantification\\\u003C1g (if urine protein ≥ 2+, additional 24-hour urine protein testing is required)\n  10. Serum lipase or amylase ≤ 1.5 x ULN or\\>1.5 x ULN (clinical or imaging diagnosis of pancreas)\n  11. International standardized ratio (INR) ≤ 1.5, and activated partial prothrombin time (APTT)≤ 1.5 x ULN.\n* Female subjects with reproductive ability have a negative blood pregnancy result within 7 days before starting the study treatment, and are willing to From the time of signing the informed consent form until the end of the last medication use, abstain from sexual activity or take medication for a period of 6 months medically recognized and efficient contraceptive measures (such as intrauterine devices, condoms, etc.), but the use of hormones is prohibited Using similar drugs for contraception; Male subjects are willing to take informed consent from the time of signing until the end of the last medication use Within the next 6 months, abstain from sexual activity or use medically recognized and effective contraceptive measures (such as condoms),and during this period, no sperm will be donated;.\n* The subjects are able to understand and voluntarily sign a written informed consent form (the informed consent form must be completed before conducting the study) Sign before any program specified in the plan.\n* Be able to voluntarily complete the research procedures and follow-up examinations according to the requirements of the research protocol.\n\nExclusion Criteria:\n\n* Mixed small cell lung cancer diagnosed by histology or cytology;\n* A history of severe allergic diseases, severe drug (including unmarketed investigational drugs) allergies, or known adverse reactions to this medication Allergy to any component of the investigational drug: presence of etoposide, platinum based drugs (carboplatin\u002Fcisplatin), or anlotinib.Individuals who are contraindicated to the use of anlotide or Toripalimab;\n* Previously received treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors.Preparation therapy (such as single\u002Fdual antibodies against CTLA-4, PD-1, PD-L1, LAG3, etc.) or anti VEGF targeted drugs;\n* Previously received curative radiotherapy (excluding those who met the inclusion criteria of 5), or before receiving study treatment.Has undergone extensive palliative radiotherapy within 4 weeks, or plans to undergo chest radiotherapy during the study period\n* Need or plan to undergo elective surgical treatment during the trial period;\n* Received the following treatments or medications before starting the research treatment:\n\n  1. Received important organ surgery (excluding puncture) within 28 days before starting the study and treatment Inspection;\n  2. Received attenuated live vaccine within 28 days prior to starting treatment;\n  3. Have used intravenous broad-spectrum antibiotics for at least 7 days within 14 days before starting the study treatment;\n  4. Starting the study on systemic corticosteroids (prednisone\\>10) received within 14 days prior to treatment Mg\u002Fday or equivalent dose of similar drugs or other immunosuppressive treatments; Except for the following situations External: Treatment with local, ocular, intra-articular, intranasal, and inhaled corticosteroids; short Regular use of glucocorticoids for preventive treatment (such as preventing contrast agent allergies);\n  5. Received palliative radiotherapy for bone metastases within 14 days prior to starting the study treatment;\n* Currently, there is spinal cord compression or superior vena cava syndrome;\n* Currently, there are clear cases of interstitial lung disease or non infectious pneumonia, except for those caused by local radiotherapy;\n* There are brain metastases in the midbrain, pons, medulla oblongata, spinal cord, meninges, and meninges, or symptomatic large brain metastases Brain or cerebellar metastasis (such as manifested as cerebral edema and\u002For progressive growth); Central nervous system conversion\n\nIndividuals limited to the brain and cerebellum can participate in screening if they meet the following conditions:\n\na. Asymptomatic brain metastases (asymptomatic central nervous system progressive symptoms caused by brain metastases, also not necessary) Using corticosteroids or antiepileptic drugs for treatment; b. Symptoms stabilize for at least 2 weeks after radiotherapy for brain metastases, and corticosteroids or antiepileptic drugs are discontinued Drug discontinuation for at least 2 weeks;\n\n* Evidence of significant coagulation disorders or other significant bleeding risks:\n\n  1. History of intracranial hemorrhage or spinal cord hemorrhage;\n  2. Patients with tumor lesions invading large blood vessels and having a significant risk of bleeding;\n  3. Within the 6 months prior to the start of the study treatment, there have been incidents of thrombosis or embolism (asymptomatic and none) Except for intramuscular venous thrombosis that requires treatment, there is no absorption during follow-up examination, or significant vascular disease is present (For aortic aneurysm, aortic dissection, etc. that require surgical repair);\n  4. Clinically significant hemoptysis or tumor development for any reason within the first 3 months prior to starting the study treatment Blood;\n  5. Within 14 days prior to the start of the study, use anticoagulant therapy for therapeutic purposes (with low prophylactic use) Excluding molecular weight heparin;\n* Past or current active autoimmune diseases or immunodeficiency, including but not limited to severe muscle disease Weakness, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammation Sexually transmitted bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sj ö gren syndrome, Grimm Barr syndrome Li syndrome or multiple sclerosis; Except for: a Autoimmune related hypothyroidism Subjects with a history of withdrawal and currently taking thyroid replacement hormone; b. Stable status receiving insulin treatment 30% of subjects with type I diabetes.\n* Lesions limited to subjects with eczema, psoriasis, chronic simple lichen, and vitiligo on the skin (if diseased)\n\nWhen the damage has already affected parts or organs outside the skin (such as psoriasis, arthritis, etc.), it cannot be included in the group:\n\ni. Fever of unknown origin\\>38.5 ℃ (fever caused by tumor can be included in the group);\n\n* Within 6 months prior to starting the study of drug therapy, the following situations occurred:\n\n  1. Suffering from congestive heart failure, severe\u002Funstable angina, cerebrovascular accident, New York, USA Cardiac insufficiency classified by the Society of Cardiology (NYHA) as Grade II or above (including Grade II), Or other structural heart diseases that have been determined by researchers to be at high risk;\n  2. History of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess;\n  3. There is uncontrollable tumor related pain, and if painkillers are needed, they should be stable during screening A prescribed pain relief treatment plan; Asymptomatic metastatic lesions, if further grown, may lead to Causing functional impairment or stubborn pain (such as epidural metastases that are currently unrelated to spinal cord compression), If appropriate, local treatment should be considered before screening;\n* Within the 5 years prior to starting the research on drug therapy, if there were other active malignant tumors, local treatment may be necessary Except for malignant tumors that have been treated and cured (such as basal cell or squamous cell carcinoma of the skin, superficial or non malignant) Invasive bladder cancer cancer, cervical carcinoma in situ, breast intraductal carcinoma in situ, thyroid papillary carcinoma);\n* Individuals who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past;\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);\n* Syphilis antibody positive and active syphilis infection present;\n* Individuals with active pulmonary tuberculosis or a history of pulmonary tuberculosis infection that cannot be controlled after treatment;\n* 20 HBsAg or HBcAb positive, and HBV-DNA\\>2000 IU\u002FmL (for For patients with HBV DNA\\>500 IU\u002FmL, the subject must agree to at least 7 days prior to the start of the study drug Continuously receiving antiviral treatment other than interferon during the research period is necessary to participate in screening; HCV antibodies Positive and HCV-RNA higher than the lower limit of detection in the experimental center (if the center is unable to detect HCV) RNA, acceptable external hospital results, relevant reports should be provided);\n* Expected to receive any other form of anti-tumor drug treatment during the trial period;\n* Known to have a history of alcohol abuse, psychotropic substance abuse, or drug use;\n* Individuals with mental disorders or poor compliance;\n* Pregnant or lactating women\n* According to the judgment of the researchers, the basic condition of the subjects may increase their risk of receiving study drug treatment,Or confusion caused by the occurrence of toxic reactions and the explanation of AE;\n* Other researchers deemed it unsuitable to participate in this experiment;","80 Years",{"count":511,"type":20},136,[200],"This is a randomized, open, multicenter Phase III clinical study. A total of 136 participants are planned to be enrolled and randomly assigned to either the experimental group (platinum+etoposide → toripalimab plus anlotinib) or the control group (platinum+etoposide+ toripalimab → toripalimab) in a 1:1 ratio. The primary efficacy measures include PFS, while secondary endpoints include OS, DOR, ORR, DCR, progression free survival at 6 and 12 months, overall survival at 12 and 18 months, health-related quality of life (FACT-L), safety, etc. And in the III clinical study, tissue samples were collected before treatment, and tumor tissue and blood samples were taken from some patients after 3 cycles of maintenance treatment and treatment progression for single-cell sequencing and transcriptome sequencing to verify the underlying mechanism research",[28,515],"Maintenance Treatment",[340,515,517,518],"Toripalimab","Anlotinib","2024-05-28",{"date":521,"type":44},"2024-06-04",{"date":523,"type":20},"2024-07-01",{"date":525,"type":20},"2030-05-01",{"name":527,"class":163},"Taizhou Hospital",{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":389,"phases":4,"briefSummary":538,"conditions":539,"keywords":545,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":164},"100524998","online-adaptive-radiotherapy-using-a-novel-linear-accelerator-ethos-100524998","NCT06116019","Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)","A Prospective Study on Online Adaptive Radiotherapy (ART) Using the ETHOS Linear Accelerator for Various Tumor Entities and the Feasibility of Integrating Multi-Parametric Patient Data Into the Adaptive Workflow","ART-02","Inclusion Criteria:\n\n* Adult patients (\\>18 years)\n* All tumor entities with an indication for radiotherapy and\u002For chemoradiotherapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients who are not capable of giving consent",{"count":537,"type":20},649,"The study focuses on the scientific and clinical evaluation of online adaptive radiotherapy (ART) using the Varian\u002FSHS ETHOS treatment system. In this study, radiation treatment plans are dynamically adjusted on a daily basis over several weeks of therapy to account for anatomical shifts in either the tumour or adjacent normal tissue - a capability that has been difficult to achieve due to technical limitations. With the ETHOS accelerator, such real-time adjustments can be made based on cone beam computed tomography (CBCT). This is a prospective observational study with the primary objective of investigating the feasibility and acceptability of performing ART with ETHOS for different tumour entities. The study will also evaluate the feasibility of integrating multi-parametric data sets into the ART workflow, such as standardised electronic feedback on treatment toxicity from both patients (ePROMS) and physicians (ePRT).",[72,77,27,28,540,541,542,543,544],"Esophageal Cancer","Bladder Cancer","Rectum Cancer","Cervix Cancer","Other Carcinoma",[546,547,548,549],"online adaptive radiation therapy","ART","cone beam CT","ePROMS","2023-10-30",{"date":552,"type":44},"2023-11-03",{"date":554,"type":44},"2023-10-11",{"date":556,"type":20},"2027-10-09",{"name":558,"class":163},"Charite University, Berlin, Germany"]