[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"China\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":679},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,16072,0,25,[9,45,67,102,130,163,188,213,252,280,303,334,362,401,431,452,476,498,521,544,568,589,608,632,654],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641813","phase-1-a-study-to-assess-the-safety-and-effects-of-abbv-1758-following-subcutaneous-or-intravenous-injections-in-participants-with-alzheimers-disease-100641813",false,"NCT07599670","A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease","Inclusion Criteria:\n\n* Participants meeting all the following criteria for Alzheimer's disease (AD):\n\n  * In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.\n  * Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).\n* Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.\n\nExclusion Criteria:\n\n* Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.\n* Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and\u002For any history of abnormal laboratory results that are indicative of significant disease(s).\n* Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.\n* Participants with other significant pathological findings on brain MRI at screening, including but not limited to:\n\n  * Evidence of vasogenic edema\n  * 4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)\n  * Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)\n  * Any superficial siderosis\n  * Severe white matter disease","ALL","50 Years","90 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body.\n\nABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan.\n\nParticipants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.",[29],"Alzheimer's Disease",[29,31],"ABBV-1758","RECRUITING","2026-08-24",{"date":35,"type":36},"2026-08-25","ACTUAL",{"date":38,"type":36},"2026-05-15",{"date":40,"type":22},"2030-10",{"name":42,"class":43},"AbbVie","INDUSTRY",12,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100641600","phase-2-a-study-of-bl-m14d1-in-combination-with-atezolizumab-in-patients-with-extensive-stage-small-cell-lung-cancer-100641600","NCT07654400","A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M14D1 for Injection in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years;\n4. Expected survival time ≥3 months;\n5. Histopathologically and\u002For cytologically confirmed extensive-stage small cell lung cancer that is incurable or for which there is currently no standard treatment;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the required criteria;\n12. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n13. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment. Serum pregnancy testing must rule out pregnancy, and the patient must not be breastfeeding. All enrolled trial participants (regardless of gender) should take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;\n2. Previous treatment with ADC drugs using topoisomerase I inhibitors as toxins;\n3. Small cell carcinoma with non-small cell carcinoma components indicated by pathology must be excluded;\n4. Use of immunomodulatory drugs within 2 weeks before the first dose of the study;\n5. Receiving long-term systemic corticosteroid therapy at a dose \\>10 mg\u002Fday of prednisone or equivalent before the first dose;\n6. History of severe cardiovascular or cerebrovascular diseases;\n7. Prolonged QTc interval, complete left bundle branch block, etc.;\n8. Active autoimmune diseases and inflammatory diseases;\n9. Diagnosis of another malignancy within 5 years before the first dose;\n10. Hypertension poorly controlled by two antihypertensive drugs;\n11. Patients with poorly controlled blood glucose;\n12. History of ILD\u002Finterstitial pneumonia treated with corticosteroids, etc.;\n13. Concomitant pulmonary diseases leading to clinically severe impairment of respiratory function;\n14. Presence of massive serous cavity effusion, or serous cavity effusion with symptoms, etc.;\n15. Imaging findings indicating that the tumor has invaded or encased major blood vessels in the chest, neck, pharynx, etc.;\n16. Any thrombotic event within 6 months before randomization;\n17. Patients with active central nervous system metastases;\n18. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug, etc.;\n19. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n20. Cumulative anthracycline dose \\>360 mg\u002Fm² during prior (neo)adjuvant anthracycline therapy;\n21. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n22. Active infections requiring systemic treatment, or occurrence of severe infection within 4 weeks before informed consent;\n23. Receipt of other unapproved clinical study drugs or treatments within 4 weeks before the first dose;\n24. Pregnant or breastfeeding women;\n25. History of severe neurological or psychiatric disorders;\n26. Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;\n27. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;\n28. History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection, or presence of Crohn's disease, ulcerative colitis, or chronic diarrhea;\n29. Trial participants who plan to receive or have received live vaccines within 28 days before the first dose;\n30. Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.","18 Years",{"count":54,"type":22},36,[26],"This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage small cell lung cancer.",[58],"Extensive-stage Small-cell Lung Cancer",{"date":35,"type":36},{"date":61,"type":36},"2026-07-09",{"date":63,"type":22},"2027-12",{"name":65,"class":43},"Sichuan Baili Pharmaceutical Co., Ltd.",1,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100630823","phase-2-a-study-of-bms-986504-monotherapy-and-in-combination-with-other-agents-in-participants-with-advanced-andor-metastatic-solid-tumors-with-homozygous-mtap-deletion-mountaintap-5-100630823","NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.",{"count":75,"type":22},260,[26],"This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[79],"Solid Tumors",[81,82,83,84,85,86,87,88,89,90,91,92,93],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Melanoma","NSCLC","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli",{"date":35,"type":36},{"date":96,"type":36},"2026-07-27",{"date":98,"type":22},"2032-05-20",{"name":100,"class":43},"Bristol-Myers Squibb",57,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100604873","phase-2-a-study-to-evaluate-the-optimal-dose-adverse-events-and-change-in-disease-activity-of-intravenous-abbv-706-in-combination-with-atezolizumab-versus-standard-of-care-as-first-line-treatment-in-adult-participants-with-previously-untreated-extensive-stage-small-cell-lung-cancer-100604873","NCT07155174","A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer","A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","SEZanne","Inclusion Criteria:\n\n* Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* Suspected brain metastases at screening should have a computed tomography (CT)\u002F magnetic resonance imaging (MRI) of the brain prior to study entry.\n\nExclusion Criteria:\n\n* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).\n* Known active\u002Fsymptomatic central nervous system (CNS) metastases should be excluded.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan should be excluded.\n* Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.",{"count":111,"type":22},180,[26],"Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).\n\nABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.\n\nIn the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[115],"Small Cell Lung Cancer",[115,117,118,119,120,121,122],"SCLC","ABBV-706","Etoposide","Carboplatin","Atezolizumab","Lurbinectedin",{"date":35,"type":36},{"date":125,"type":36},"2025-11-25",{"date":127,"type":22},"2031-09",{"name":42,"class":43},67,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":138,"type":22},500,[26,140],"PHASE3","A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[143],"Non-Small Cell Lung Cancer",[145,146,147,148,149,150,151,152,153,120,154,155],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Cisplatin","Pemetrexed",{"date":35,"type":36},{"date":158,"type":36},"2025-11-05",{"date":160,"type":22},"2030-11-15",{"name":100,"class":43},186,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":172,"type":22},590,[26,140],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[176],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[83,178,89,81,82,179,180,92],"Lung cancer","MRTX1719","First-line",{"date":35,"type":36},{"date":183,"type":36},"2026-01-02",{"date":185,"type":22},"2031-08-12",{"name":100,"class":43},320,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":197,"type":22},450,[140],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[201],"Bipolar Disorder Type I With Mania",[203,204,205],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":35,"type":36},{"date":208,"type":36},"2025-07-18",{"date":210,"type":22},"2028-06-13",{"name":100,"class":43},174,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":221,"minAge":52,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100581820","phase-3-study-comparing-aaa817arpi-versus-standard-of-care-in-adult-participants-with-psma-positive-mcrpc-100581820","NCT06855277","Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer","AcTFirst","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have histological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.\n* Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.\n* Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).\n* Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.\n* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).\n\n  * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.\n\nKey Exclusion Criteria:\n\n* Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \\[177Lu\\]Lu-PSMA, \\[177Lu\\]-DOTA, or Radium- 223.)\n* Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).\n\n  * Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.\n\nNote: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE","100 Years",{"count":224,"type":22},940,[140],"The purpose of this study is to determine whether \\[225Ac\\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +\u002F- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \\[177Lu\\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.",[228],"Prostate Cancer",[230,231,232,233,234,235,236,237,238,239,240,241,219,242,243],"Positive Metastatic Castration Resistant Prostate Cancer","PSMA","PSMA-positive","AAA817","[225AC] AC-PSMA-617","Radioligand Therapy","RLT","Androgen receptor pathway inhibitor","ARPI","Taxane","Metastatic castration resistant prostate cancer","mCRPC","[177Lu]Lu- PSMA-617","AAA617",{"date":35,"type":36},{"date":246,"type":36},"2025-07-01",{"date":248,"type":22},"2032-11-04",{"name":250,"class":43},"Novartis Pharmaceuticals",93,{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":260,"minAge":261,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100522211","phase-3-study-of-volrustomig-in-women-with-high-risk-locally-advanced-cervical-cancer-evolve-cervical-100522211","NCT06079671","Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","eVOLVECervical","Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\\u003C 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO\u002FECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg\u002Fday of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","FEMALE","15 Years",{"count":263,"type":22},800,[140],"This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.",[267],"Locally Advanced Cervical Cancer",[269,270,271],"Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig",{"date":35,"type":36},{"date":274,"type":36},"2023-09-22",{"date":276,"type":22},"2030-09-30",{"name":278,"class":43},"AstraZeneca",205,{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674","NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant",{"count":138,"type":22},[289],"NA","A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[292,293,294],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":35,"type":36},{"date":297,"type":36},"2023-12-27",{"date":299,"type":22},"2029-08",{"name":301,"class":43},"Orchestra BioMed, Inc",130,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":222,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":333},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply",{"count":312,"type":22},1400,[140],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[316],"Early Breast Cancer",[318,319,320,321,322,323,324,325,326],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":35,"type":36},{"date":329,"type":36},"2024-02-28",{"date":331,"type":22},"2030-09-20",{"name":250,"class":43},228,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":361},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":342,"type":22},626,[26,140],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[346,347],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[349,350,89,347,351,352,353],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":35,"type":36},{"date":356,"type":36},"2020-12-02",{"date":358,"type":22},"2029-10-31",{"name":360,"class":43},"Mirati Therapeutics Inc.",770,{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":222,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":373,"conditions":374,"keywords":379,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.",{"count":370,"type":22},100,[372],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[88,375,376,377,378],"Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers","High Grade Glioma",[380,381,382,383,384,88,385,386,387,388,389,375,390,391,392,393,378],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":35,"type":36},{"date":396,"type":36},"2018-01-26",{"date":398,"type":22},"2032-12-28",{"name":250,"class":43},33,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":408,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":415,"overallStatus":421,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":66},"100653331","phase-1-a-study-to-evaluate-the-efficacy-and-safety-of-intravesical-instillation-of-disitamab-vedotin-combined-with-toripalimab-in-patients-with-her2-positive-high-risk-non-muscle-invasive-bladder-cancer-who-are-bcg-nave-or-have-bcg-failure-100653331","NCT07783815","A Study to Evaluate the Efficacy and Safety of Intravesical Instillation of Disitamab Vedotin Combined With Toripalimab in Patients With HER2-Positive High-Risk Non-Muscle Invasive Bladder Cancer Who Are BCG-Naïve or Have BCG Failure","An Open-Label, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Intravesical Instillation of Disitamab Vedotin Combined With Toripalimab in Patients With HER2-Positive High-Risk Non-Muscle Invasive Bladder Cancer Who Are BCG-Naïve or Have BCG Failure","Inclusion Criteria:\n\n1. Voluntarily agree to participate in the research and sign the informed consent form.\n2. Within 3 weeks after TURBT surgery, the tumor tissue specimens obtained from the subjects were subjected to immunohistochemical (IHC) testing for HER2 expression, which met the criteria of 1+, 2+ or 3+. If the IHC result was 2+, FISH verification for amplification was required.\n3. ECOG physical condition: 0 - 2 points.\n4. Sufficient heart, bone marrow, liver and kidney functions should meet the following standards within 7 days before the drug administration study (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g\u002FdL; Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelets ≥ 100 × 10\\^9\u002FL; Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL\u002Fmin according to the Cockcroft-Gault formula.\n5. Within 3 weeks after TURBT surgery, the tumor tissue specimens obtained from the subjects were subjected to immunohistochemical (IHC) testing for HER2 expression, which met the criteria of 1+, 2+ or 3+. If the IHC result was 2+, FISH verification for amplification was required.\n6. ECOG physical condition: 0 - 2 points.\n7. Sufficient heart, bone marrow, liver and kidney functions should meet the following standards within 7 days before the drug administration study (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g\u002FdL; Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelets ≥ 100 × 10\\^9\u002FL; Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL\u002Fmin according to the Cockcroft-Gault formula.\n8. The female subjects should be patients who have undergone surgical sterilization or menopause, or those who agree to use at least one medically approved contraceptive method (such as intrauterine device, contraceptive pills or condoms) during the study treatment period and within 6 months after the end of the study treatment. The blood pregnancy test must be negative within 7 days before the subject is enrolled in the study. False positive results can be excluded after confirming pregnancy by the investigator and then the subject can be enrolled. Male subjects should agree to use at least one medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment.\n9. Willing and able to comply with the arrangements of the trial and follow-up procedures.\n10. Willing and able to comply with the arrangements of the trial and follow-up procedures.\n\nExclusion Criteria:\n\n1. Muscle-invasive bladder cancer (T2 and above) and\u002For those with regional lymph node and distant metastasis.\n2. Combined urinary tract urothelial carcinoma outside the bladder (i.e., in the urethra, ureters or renal pelvis).\n3. The study excluded any patients who had received any other anti-tumor treatments within 4 weeks prior to the administration of the drug, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. This exclusion did not include the one-time perfusion chemotherapy immediately performed after TURBT.\n4. Before the start of the drug study, there was no recovery from the adverse events caused by the previously used anti-tumor drugs to the 0-1 level of CECAT within 2 weeks.\n5. Those who started the drug administration within 4 weeks before the study or those who planned to undergo major surgery during the trial period.\n6. Serological virological examination (based on the normal values of the research center): HBsAg or HBcAb test results are positive, and HBVDNA copy number is also positive; HCVAb test result is positive, and HCV RNA test result is also positive; HIVAb test result is positive.\n7. The study excluded participants who had received live vaccines within 4 weeks prior to the start of the treatment or who planned to receive any vaccines during the study period (except for the novel coronavirus inactivated virus vaccine).\n8. Heart failure classified as grade 3 or above by the New York Heart Association (NYHA) in the United States.\n9. The study excluded cases where there had been severe arterial\u002Fvenous thrombosis events or cardiovascular\u002Fcerebrovascular accidents within 6 months before administration, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc. However, cases of asymptomatic and non-requirement-of-clinical-intervention lacunar cerebral infarction were included.\n10. There are active or progressive infections that require systematic treatment, such as active tuberculosis.\n11. There are systemic diseases that have been judged by the researchers to be active and not yet under stable control, as well as severe comorbidities, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.\n12. Previous history of receiving allogeneic hematopoietic stem cell transplantation or organ transplantation.\n13. Those who are known to be allergic to RC48-ADC\u002FTeripipor or any of its components or any of the excipients.\n14. Pregnant or lactating women.\n15. It is estimated that the patient's compliance with this clinical study is insufficient.","75 Years",{"count":410,"type":22},20,[25],"This study is an open-label, single-arm investigator-initiated clinical trial, aiming to evaluate the efficacy and safety of vicedetinib bladder instillation combined with teprotumumab in the treatment of patients with HER2-expressing, previously untreated, or BCG-resistant high-risk non-muscle-invasive bladder cancer (NMIBC). The subjects to be included in the study must have undergone standard TURBT within 3 weeks before enrollment, removed all visible lesions, and had a clear pathological diagnosis of NMIBC, with their risk classification according to the \"Chinese Bladder Cancer Diagnosis and Treatment Guidelines (2022)\" falling into the high-risk group (including extremely high-risk group). All surgical tumor specimens of the included subjects underwent HER2 testing, indicating HER2 expression, defined as immunohistochemistry (IHC) 1+, 2+ or 3+, with FISH verification for amplification if IHC 2+ is present. The subjects were divided into two groups based on whether they had received BCG treatment in the past: one group was high-risk NMIBC patients who had not received BCG treatment, including one of the following situations: ① refused BCG treatment, ② had contraindications to BCG use, ③ BCG was inaccessible; the other group was high-risk NMIBC patients who had no response to BCG, meeting any of the following criteria: ① had persistent\u002Frecurrent high-risk NMIBC within 12 months (±1 month) after adequate BCG treatment, ② had high-grade T1 disease during the first assessment after induction BCG treatment. Adequate BCG treatment was defined as completing at least 5 BCG bladder instillations within 2 months, and then at least 2 BCG bladder instillations for 6 consecutive weeks within the next 10 months, meaning at least \"5+2\" BCG bladder instillations within approximately 12 months. Eligible subjects received vicedetinib bladder instillation combined with teprotumumab treatment; vicedetinib was administered once weekly at 180mg for 8 times. For patients receiving treatment, if there was no occurrence of persistent\u002Frecurrent NMIBC, disease progression, or intolerable toxicity, they would receive maintenance bladder instillation with vicedetinib for one year, with the maintenance regimen being: once every 4 weeks for 10 times. Teprotumumab: 240mg per dose, intravenous, once every 3 weeks for 1 year. Patients were required to collect urine samples before the first treatment and after the last treatment. Safety during the study was evaluated according to the NCI-CTCAE V5.0 standard, and the observation indicators included vital signs, physical examination, laboratory tests, electrocardiogram and echocardiogram examinations, adverse events and serious adverse events.",[414],"Bladder Cancer",[416,417,418,419,420],"High-risk non-muscle-invasive bladder cancer","Disitamab Vedotin","Toripalimab","Bladder instillation","HER2","NOT_YET_RECRUITING","2026-08-23",{"date":35,"type":36},{"date":425,"type":22},"2026-09-01",{"date":427,"type":22},"2030-02-01",{"name":429,"class":430},"Xiangya Hospital of Central South University","OTHER",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":421,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":66},"100653271","the-effect-of-perioperative-intravenous-lidocaine-infusion-on-post-amputation-pain-in-amputee-patients-100653271","NCT07783867","The Effect of Perioperative Intravenous Lidocaine Infusion on Post-amputation Pain in Amputee Patients","Effect of Perioperative Intravenous Lidocaine Infusion on Post-amputation Pain in Patients Undergoing Amputation","Inclusion Criteria:\n\n* 1.Age 18-80 years; 2.Patients scheduled for elective or emergency primary above or below knee amputation (AKA or BKA) under general anesthesia; 3.American Society of Anesthesiologists (ASA) physical status I-III. The exclusion criteria.\n\nExclusion Criteria:\n\n* 1\\. Body weight \\\u003C 40 kg or \\> 100 kg； 2. Cardiac conduction defects (second- or third-degree atrioventricular block) or cardiac insufficiency (left ventricular ejection fraction \\[LVEF\\] \\\u003C 50%)； 3. Severe hepatic impairment (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], or bilirubin levels \\> 2.5 times the upper limit of normal) 4. Renal insufficiency (creatinine clearance \\[CrCl\\] \\\u003C 60 mL\u002Fmin)； 5. Known allergy to the study drug； 6. Chronic opioid abuse； 7. Patients unable to communicate verbally.","80 Years",{"count":440,"type":22},200,[289],"This study aimes to evaluate whether perioperative intravenous lidocaine infusion effectively relieves postoperative pain, enhances recovery, and reduces chronic stump and phantom limb pain after amputation, thereby informing future multicenter trials and clinical guideline development.",[444],"Amputation",{"date":35,"type":36},{"date":447,"type":22},"2026-10-01",{"date":449,"type":22},"2029-12-30",{"name":451,"class":430},"West China Hospital",{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":421,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":472,"leadSponsor":474,"locationsCount":66},"100653262","artificial-intelligence-support-for-stroke-100653262","NCT07785492","Artificial Intelligence Support for Stroke","Artificial Intelligence-Assisted Decision Support for Intravenous Thrombolysis in Acute Ischemic Stroke at Basic Hospitals in China (ASSIST)","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Clinical diagnosis of acute ischemic stroke.\n3. Onset time (last known well) \\\u003C24 hours.\n4. CT or MRI examination excluding intracerebral hemorrhage.\n5. Signed informed consent by the patient or a legally authorized representative\n\nExclusion Criteria:\n\n1. Currently participating in another interventional clinical trial related to drugs or devices.\n2. Pregnant women.\n3. Has received intravenous thrombolysis at another hospital.\n4. Has completed a definitive reperfusion therapy decision at another hospital and is transferred to this hospital solely for follow-up observation or rehabilitation.",{"count":460,"type":22},516,[289],"This study investigates whether an AI-assisted decision support tool, compared with standard care, increases the proportion of acute ischemic stroke patients receiving intravenous thrombolysis within 24 hours of symptom onset at a primary hospital in China, while also evaluating its impact on clinical outcomes, treatment timelines, and safety.",[464],"Ischemic Stroke, Acute",[466,467,468,469],"Randomized Controlled Trial","Stroke","AI","Thrombolysis",{"date":35,"type":36},{"date":425,"type":22},{"date":473,"type":22},"2027-03-31",{"name":475,"class":430},"Capital Medical University",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":260,"minAge":52,"maxAge":408,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":497},"100652553","phase-4-an-exploratory-study-on-the-efficacy-and-safety-of-enlonstobart-combined-with-concurrent-radiotherapy-and-chemotherapy-following-induction-therapy-with-enlonstobart-plus-chemotherapy-in-patients-with-locally-advanced-cervical-cancer-100652553","NCT07776821","An Exploratory Study on the Efficacy and Safety of Enlonstobart Combined With Concurrent Radiotherapy and Chemotherapy Following Induction Therapy With Enlonstobart Plus Chemotherapy in Patients With Locally Advanced Cervical Cancer.","Inclusion Criteria:\n\n* Ages 18-75;\n* Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma confirmed by histology or cytopathology;\n* Patients with locally advanced cervical cancer who have not previously received any treatment and are classified as FIGO stage III-IV A as of 2018;\n* ECOG performance status 0-1;\n* Left ventricular ejection fraction (LVEF) ≥ 50%;\n* Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FdL, platelets (PLT) ≥ 100 × 10⁹\u002FL;\n* Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); if liver metastases are present, ≤ 5×ULN; total bilirubin ≤ 1.5×ULN (this limit may be relaxed to 3×ULN for subjects with Gilbert's syndrome);\n* Renal function: Serum creatinine (Cr) ≤ 1.5×ULN; if \\> 1.5×ULN, creatinine clearance must be ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n* Coagulation: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN;\n* According to the RECIST 1.1 criteria, the patient must have at least one evaluable lesion;\n* Patients of childbearing potential must have a negative pregnancy test result and voluntarily use effective and reliable contraception during the study;\n* Voluntarily participate in the study and sign an informed consent form.\n\nExclusion Criteria:\n\n* A history of active malignant tumors within 3 years prior to the first dose, excluding cervical cancer, which is the subject of this trial, and any locally curable tumors that have already undergone curative treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, or cured carcinoma in situ, such as ductal carcinoma in situ of the breast);\n* Patients with active tuberculosis or a history of tuberculosis;\n* Patients with a history of interstitial lung disease or non-infectious pneumonia requiring glucocorticoid therapy;\n* Patients with hypertension that is not adequately controlled with antihypertensive medication (defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 90 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;\n* Those who have experienced a serious cardiovascular event within 6 months prior to randomization, including but not limited to: stable angina classified as NYHA Class III-IV; unstable angina or myocardial infarction; NYHA Class III-IV congestive heart failure; severe arrhythmias requiring medication (asymptomatic atrial fibrillation is permitted if the ventricular rate can be controlled); Severe arterial or venous thromboembolic events (e.g., intracerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism);\n* Patients with active autoimmune diseases, or a history of autoimmune diseases within the 2 years prior to randomization, who still require systemic treatment. However, subjects with the following conditions may be considered for further screening: well-controlled type 1 diabetes; hypothyroidism requiring only hormone replacement therapy and well-controlled; skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia); or subjects whose condition is not expected to recur in the absence of external triggers.\n* Individuals with a known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS);\n* Subjects with uncontrolled pleural, pericardial, or abdominal\u002Fpelvic effusions requiring repeated drainage;\n* Subjects who have received immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (prednisone \\>10 mg\u002Fday or other equivalent medications) within 2 weeks prior to receiving the study drug;\n* Subjects who have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within 28 days prior to the first administration of the study drug, or who still have unhealed wounds, ulcers, or fractures at the time of screening;\n* Subjects with a history of allogeneic hematopoietic stem cell transplantation or organ transplantation;\n* Subjects with other conditions deemed by the investigator to be incompatible with participation in this trial.",{"count":483,"type":22},31,[372],"The objective of this clinical trial is to investigate the efficacy and safety of Enlonstobart combined with concurrent chemoradiotherapy following induction chemotherapy for locally advanced cervical cancer. The primary questions it aims to address are:\n\nCan the Enlonstobart combination regimen improve the objective response rate and disease control rate in patients with locally advanced cervical cancer? What is the safety and tolerability profile of this combination regimen, and will any unexpected serious adverse events occur?\n\nParticipants will:\n\nReceive induction therapy with Enlonstobart in combination with chemotherapy agents (e.g., paclitaxel plus platinum); Receive Enlonstobart in combination with concurrent chemoradiotherapy (external beam radiation therapy plus brachytherapy, with concurrent chemotherapy); Undergo regular tumor imaging evaluations (CT\u002FMRI) and hematological safety assessments; Cooperate in completing efficacy assessments, adverse event documentation, and long-term follow-up.",[487],"Uterine Cervical Neoplasms",[489],"locally advanced carcinoma of the cervix",{"date":35,"type":36},{"date":492,"type":36},"2025-09-01",{"date":494,"type":22},"2026-11-01",{"name":496,"class":430},"Tianjin Medical University Cancer Institute and Hospital",2,{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":511,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":497},"100624640","phase-2-a-study-of-chidamide-combined-with-ivonescimab-in-the-treatment-of-advanced-non-small-cell-lung-cancer-nsclc-with-acquired-resistance-to-immunotherapy-and-high-yes-associated-protein-yap-expression-100624640","NCT07412262","A Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression","A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression","NSCLC， YAP","Inclusion Criteria:\n\n1. Written informed consent must be signed before implementing any trial-related procedures;\n2. Age ≥18 years old;\n3. Have histologically or cytologically confirmed locally advanced (IIIB\u002FIIIC stage), metastatic or recurrent (IV stage) non-small cell lung cancer (NSCLC) that is not operable and not suitable for radical concurrent chemoradiotherapy, as classified by the 9th edition of the TNM staging system of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;\n4. Previously received first-line PD-1\u002FPD-L1 inhibitor monotherapy or combination therapy, with a progression-free survival (PFS) of ≥ 6 months under the initial PD-1\u002FPD-L1-containing treatment regimen;\n5. Previously received only first-line systemic treatment;\n6. Able to provide 15 pieces of biopsied tumor tissue or tumor tissue sections after PD-1\u002FPD-L1 treatment resistance, pathologically confirmed as non-small cell lung cancer, and centrally laboratory-confirmed high YAP protein expression. Eligible subjects voluntarily provide 5-15 sections of tumor tissue samples from initial diagnosis. (YAP immunohistochemical staining intensity is graded as 0 (negative), 1+ (weak), 2+ (moderate), and 3+ (strong); the proportion of positive tumor cells is graded as 0 (0-5%), 1+ (6-25%), 2+ (26-50%), 3+ (51-75%), and 4+ (\\>75%). The YAP IHC score is calculated by multiplying the staining intensity by the proportion of positive tumor cells: YAP IRS = Staining Intensity (A) × Proportion of Positive Tumor Cells (B). A YAP IHC score \\\u003C 6 indicates low YAP expression, and ≥ 6 indicates high YAP expression);\n7. Asymptomatic brain metastasis patients are eligible for enrollment;\n8. Palliative radiotherapy completed within 2 weeks before study enrollment is allowed, and radiotherapy-related toxicity has recovered to ≤ Grade 1 (CTCAE 5.0). Radiated lesions are not considered evaluable lesions unless there is evidence of progression after radiotherapy;\n9. No prior use of any traditional Chinese medicine (TCM) with anti-tumor effects, or prior use of TCM with anti-tumor effects no more than 3 times (one dose counts as one time), and discontinuation of such TCM for ≥ 2 weeks before the start of study drug treatment.\n\n   Patients must meet the following laboratory test requirements at screening:\n10. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL without the use of growth factors in the past 14 days;\n11. Platelet count ≥ 80 × 10⁹\u002FL and hemoglobin ≥ 80 g\u002FL without blood transfusion in the past 14 days;\n12. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN) (patients with liver metastasis are allowed to have ALT or AST ≤ 5 × ULN);\n13. Total bilirubin ≤ 1.5 × ULN (patients with liver metastasis or biliary obstructive tumors are allowed to have ≤ 2.5 × ULN);\n14. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 45 ml\u002Fmin;\n15. ECOG performance status score of 0-1;\n16. Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN;\n17. Expected survival time \\> 12 weeks;\n18. Negative pregnancy test (applicable only to women of childbearing potential).\n\nExclusion Criteria:\n\n1. Have a history of severe bleeding tendency or coagulation disorders; have significant clinical bleeding symptoms within 4 weeks before enrollment, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing or expectorating ≥ 1 teaspoon of fresh blood or small blood clots or only coughing blood without sputum, subjects with blood in sputum are allowed to enroll), nasal bleeding (excluding epistaxis and retracted nasal blood); continuous antiplatelet or anticoagulant therapy within 14 days before the first dose;\n2. History of gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), esophagogastric varices, severe ulcers, unhealed wounds, abdominal fistulas, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before the first dose; extensive intestinal resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea);\n3. Hypersensitivity to any study drug or its components;\n4. Exclusion of central squamous cell lung cancer invading large blood vessels;\n5. Patients who experienced Grade 3 or above immune-related adverse reactions with prior immunotherapy drugs, and investigators assess that immunotherapy has safety concerns with risks outweighing benefits;\n6. Any arterial thromboembolic event, Grade 3 or above venous thromboembolic event as specified by NCI CTCAE 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months before the first dose;\n7. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before the first dose;\n8. Complicated with severe uncontrolled concurrent infections or other severe uncontrolled comorbidities, moderate or severe renal impairment (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.);\n9. Active hepatitis B or C infection (hepatitis B surface antigen positive and hepatitis B virus DNA \\> 1 × 10³ copies\u002FmL; hepatitis C virus RNA \\> 1 × 10³ copies\u002FmL);\n10. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);\n11. Clinically significant active infection, active pulmonary tuberculosis;\n12. Past or current clinically active interstitial lung disease; current active pneumonia; current radiation pneumonitis requiring hormone therapy;\n13. Evidence of severe or uncontrolled systemic diseases (e.g., severe mental or neurological diseases, epilepsy, or dementia not stably controlled by drugs; unstable or decompensated respiratory, cardiovascular, hepatic, or renal diseases; uncontrolled hypertension \\[i.e., hypertension ≥ CTCAE Grade 3 despite drug treatment\\]; hyperglycemia \\[fasting blood glucose \\> 10 mmol\u002FL\\]);\n14. Clinically significant ventricular arrhythmia within 12 months before the first dose, atrial fibrillation not stably controlled by drugs, unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ Grade 2, or vascular diseases (e.g., aortic aneurysm at risk of rupture), or other cardiac impairments that may affect the safety evaluation of study drugs (e.g., uncontrolled arrhythmia, myocardial ischemia, etc.);\n15. Past or current concurrent other malignant tumors (except for well-controlled non-melanoma cutaneous basal cell carcinoma, in situ breast\u002Fcervical cancer, and other malignant tumors that have been well-controlled without treatment for the past five years);\n16. Tumor invasion of large vascular structures (e.g., pulmonary artery, superior vena cava, or inferior vena cava) detected at screening, or obvious necrosis\u002Fcavitation, which is judged by investigators to have a high risk of bleeding;\n17. Active bleeding or taking therapeutic doses of anticoagulant drugs with a tendency to major bleeding;\n18. Clinically uncontrolled pleural effusion\u002Fascites\u002Fpericardial effusion;\n19. Currently participating in interventional clinical study treatment, or receiving other study drugs or study devices within 2 weeks before the first dose;\n20. Systemic treatment with Chinese patent medicines indicated for lung cancer or immunomodulatory drugs (including thymopeptides, interferons, interleukins, excluding local use for controlling pleural effusion) within 2 weeks before the first dose;\n21. History of solid organ or hematopoietic stem cell transplantation;\n22. Diagnosis of autoimmune disease and receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Note: Physiological doses of glucocorticoids (≤ 20 mg\u002Fday prednisone or equivalent) are allowed;\n23. Failure to fully recover from toxicity and\u002For complications caused by any intervention before the start of treatment (i.e., ≤ Grade 1 or return to baseline, excluding fatigue or alopecia);\n24. Vaccination with live vaccines within 30 days before the first dose (Cycle 1, Day 1). Note: Inactivated viral vaccines for seasonal influenza administered by injection are allowed within 30 days before the first dose; however, intranasal attenuated live influenza vaccines are not allowed;\n25. Pregnant or lactating women, and fertile patients unwilling to use contraceptive measures;\n26. Concurrent other malignant tumors requiring treatment;\n27. Patients judged by investigators to be unsuitable for participating in the study.",{"count":507,"type":22},32,[26],"This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of Chidamide in combination with Ivonescimab in the treatment of advanced non-small cell lung cancer with secondary immune resistance and high YAP protein expression.",[143],[512,513],"YAP protein","Acquired immune resistance",{"date":35,"type":36},{"date":516,"type":22},"2026-08-28",{"date":518,"type":22},"2029-03-31",{"name":520,"class":430},"Guangdong Association of Clinical Trials",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":408,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":66},"100622915","efficacy-of-acupuncture-mesalazine-combination-therapy-in-ulcerative-colitis-100622915","NCT07389824","Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.","Efficacy of Acupuncture Combined With Mesalazine in Inducing and Maintaining Clinical Remission in Mild-to-Moderate Active Ulcerative Colitis: A Single-Center, Randomized Controlled Clinical Trial.","Inclusion Criteria:\n\n1. documented diagnosis of UC；\n2. age 18-75 years, regardless of gender;\n3. mildly to moderately active UC, defined as a baseline total Mayo score between 3 and 10；\n4. willing to receive the complete protocol of intradermal thumbtack needle embedding therapy (12 sessions across three treatment courses)；\n5. Willing to undergo two colonoscopies (pre-treatment and post-treatment)；\n6. complete all baseline assessments;\n7. capable of understanding and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. diagnosed with or suspected to have other type of inflammatory bowel disease, such as Crohn's disease;\n2. patients in clinical remission or with severe disease activity ( baseline total Mayo score \\\u003C 3, or \\> 10 );\n3. having severe gastrointestinal complications or a recent surgical history, including but not limited to: short bowel syndrome, toxic megacolon, intestinal perforation, complete intestinal obstruction, active massive gastrointestinal hemorrhage, or having undergone major abdominal or intestinal surgery within the past 6 months.\n4. patients unwilling to undergo colonoscopy;\n5. significant or unstable comorbidities (e.g., cardiovascular, respiratory, hepatic, or renal diseases);\n6. patients with malignant tumors (including but not limited to colorectal cancer);\n7. patients with a history of intradermal thumbtack needle embedding;\n8. pregnant or lactating women;\n9. patients with mental illness;\n10. patients with either coagulation disorders or skin conditions (such as diseases, infections, ulcers, scars, or tumors at the acupuncture sites) that would preclude acupuncture；\n11. strong needle phobia or unwillingness to receive acupuncture treatment;\n12. any other condition (e.g., geographical remoteness, history of poor adherence) that, in the opinion of the investigator, would make the patient unsuitable for the study or likely to be non-compliant with the protocol.",{"count":529,"type":22},66,[289],"This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.",[533],"Ulcerative Colitis",[535,536,533],"Acupuncture","Mesalazine",{"date":35,"type":36},{"date":539,"type":36},"2026-02-01",{"date":541,"type":22},"2027-12-31",{"name":543,"class":430},"Qin Yu",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":552,"sex":17,"minAge":553,"maxAge":554,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":557,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":66},"100580372","impact-of-glasses-for-vision-problems-on-cognitive-function-in-rural-older-adults-100580372","NCT06836440","Impact of Glasses for Vision Problems on Cognitive Function in Rural Older Adults","The Impact of Spectacle Intervention for Refractive Error and Presbyopia on Cognitive Function in Rural Older Adults","CLEVER","Inclusion Criteria:\n\n* Older adults who meet all of the following criteria will be eligible to participate in this study:\n\n  * Registered as a rural resident (holding rural household registration);\n  * Age from 60 to 79 years at the time of enumeration;\n  * Resident in the household for \\> = 3 months and planning to reside in the local area for the trial duration;\n  * Distance vision impairment (VI, presenting visual acuity \\[VA\\] \\\u003C 6\u002F12 in the better-seeing eye and improving to ≥ 6\u002F7.5 or better in either eye with spectacle correction) and\u002For near VI (presenting near VA \\\u003C 6\u002F12 at 40 cm when measured binocularly and improving to ≥ 6\u002F7.5 or better in either eye with near correction);\n  * Independent mobility with or without the support of a walking stick;\n  * Chinese version of the Mini-Mental State Examination (C-MMSE) score above the following cut-offs (out of 30): \\>17 for illiterate participants, \\>20 for those with primary school education, \\>22 for those with junior high school education, and \\>23 for those with high school education or above.\n  * Willingness to participate, to be randomized to either study group, and to adhere to the protocol\n\nExclusion Criteria:\n\n* Presence of glaucoma or visually significant cataract, or a history of surgical treatment for these or other major ocular conditions;\n* Consistent use of prescription spectacles and\u002For hearing aids;\n* Serious medical illness likely to result in loss to follow-up. Those less severely affected by conditions such as hypertension and\u002For diabetes will be eligible;\n* Failure on the whispered voice hearing screening test in the better ear (unable to repeat \\> = 3 out of 6 words whispered from behind the participant at a distance of 50 cm);",true,"60 Years","79 Years",{"count":556,"type":22},964,[289],"The aim of this project is to explore whether vision correction can effectively slow cognitive decline in older adults.\n\nThe primary question it seeks to answer is: Can providing free near and\u002For distance vision correction glasses to older adults with refractive errors or uncorrected vision, who have normal baseline cognition and hearing, reduce the rate of cognitive decline over 36 months in a cost-effective manner? Researchers will compare the rate of cognitive decline over 36 months between older adults who receive refractive correction and those who do not.",[560],"Cognition Disorders",{"date":35,"type":36},{"date":563,"type":36},"2025-11-10",{"date":565,"type":22},"2030-12-31",{"name":567,"class":430},"Yuju Wu",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":438,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":66},"100512158","phase-2-ty-9591-in-the-patients-with-egfr-mutations-in-advanced-nsclc-with-brain-metastases-100512158","NCT05948813","TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases","A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases","Inclusion Criteria:\n\n1. Male or female aged ≥18 years and \\\u003C80 years.\n2. Patients diagnosed with NSCLC by histology or cytology, with brain metastases.\n3. Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites).\n4. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.\n5. Stable brain metastases that do not require immediate or planned local treatment for it during the study period.\n6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n7. The ECOG score is 0-1, and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.\n8. Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.\n9. Male patients and female patients of reproductive age should take adequate contraceptive measures from signing informed consent to 3 months after the last study drug treatment; Women of childbearing age have negative pregnancy test results within 7 days of the first dose.\n10. Patients having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed) before first dose of study treatment.\n11. Patients can understand and voluntarily sign the informed consent form.\n12. Patient able to comply with study requirements.\n\nExclusion Criteria:\n\n1. Any of the following treatment:\n\n   1. Previous treatment with EGFR inhibitor;\n   2. Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)；\n   3. Previous treatment with standard chemotherapy with 28 days before the first dose of the study drug, and traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug;\n   4. Previous whole brain radiation therapy (WBRT); Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis;\n   5. Uncontrollable or poorly controlled pleural, abdominal and pericardial effusion;\n   6. Uncontrollable cancerous pain; Anesthetic painkillers did not reach a stable dose at the time of enrollment;\n   7. Major surgery within 28 days of the first dose of study treatment;\n   8. Patients currently receiving (or at least within 14 days prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4;\n   9. Patients who are receiving and need to continue receiving medications during the study that are known to prolong the QTc interval or may cause tachycardia;\n   10. Participants in other clinical trials (other than non-interventional clinical trials) within 28 days prior to the first administration of the investigational drug.\n2. Patients with primary malignant brain tumors and unstable brain metastases.\n3. Patients who have had or have a history of other malignancies within the past 5 years (except cured basal cell or squamous cell carcinoma of the skin, papillary carcinoma of the thyroid gland, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast).\n4. The patient had symptoms of spinal cord compression caused by the tumor.\n5. Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.\n6. Cardiac function and disease are consistent with the following:\n\n   1. Corrected QT interval(QTc)\\> 470 milliseconds from 3 electrocardiograms (ECGs);\n   2. Any clinically important abnormalities in rhythm;\n   3. Any factors that increase the risk of QTc prolongation;\n   4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n7. Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.\n8. Previous history of interstitial lung disease(ILD) or drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.\n9. Previous allogeneic bone marrow transplant.\n10. Pregnant or lactating women.\n11. Any other disease or medical condition that is unstable or may affect the safety or study compliance.\n12. Hypersensitivity to TY-9591 or similar compounds or excipients.",{"count":576,"type":22},420,[26],"This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.",[89,580,581],"EGFR Activating Mutation","Brain Metastases",{"date":35,"type":36},{"date":584,"type":36},"2023-08-17",{"date":586,"type":22},"2030-03-30",{"name":588,"class":43},"TYK Medicines, Inc",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":438,"enrollmentInfo":596,"targetDuration":4,"studyType":597,"phases":4,"briefSummary":598,"conditions":599,"keywords":4,"overallStatus":421,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":604,"leadSponsor":606,"locationsCount":66},"100653177","clinical-evaluation-of-salivary-15-anhydroglucitol-in-diabetes-100653177","NCT07781683","Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes","Development and Application of a Novel Noninvasive Salivary 1,5-Anhydroglucitol Detection Technology in Diabetes Management","Inclusion Criteria:\n\n1. Aged between 18 and 80 years.\n2. Individuals without a history of diabetes, or patients with type 2 diabetes mellitus.\n\nExclusion Criteria:\n\n1. History of systemic glucocorticoid treatment within the previous 6 weeks.\n2. Presence of acute infection.\n3. Presence of severe oral conditions that may affect saliva collection or measurement.\n4. Presence of severe hepatic or renal dysfunction.\n5. History of alcohol abuse or psychiatric disorders, including depression.\n6. Current treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors.",{"count":111,"type":22},"OBSERVATIONAL","The goal of this observational study is to evaluate the clinical value of salivary 1,5-anhydroglucitol (1,5-AG) and assess a novel noninvasive detection approach in individuals with and without type 2 diabetes. Additionally, the study will examine the relationships of salivary 1,5-AG with serum 1,5-AG and continuous glucose monitoring (CGM) measures of short-term glycemic control and fluctuations.",[600],"Type 2 Diabetes (T2DM)","2026-08-22",{"date":35,"type":36},{"date":425,"type":22},{"date":605,"type":22},"2028-12-31",{"name":607,"class":430},"Shanghai 6th People's Hospital",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":23,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":421,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":66},"100652821","phase-2-the-study-of-andamertinib-plus-anlotinib-in-patients-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100652821","NCT07780578","The Study Of Andamertinib Plus Anlotinib In Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","A Single Arm, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Andamertinib Combined With Anlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Failed Prior First Line Third Generation EGFR TKI Therapy","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the written informed consent form.\n2. Aged ≥ 18 years, male or female.\n3. Non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically, clinically diagnosed as unresectable and ineligible for curative concurrent chemoradiotherapy, including locally advanced (stage ⅢB\u002FⅢC), metastatic or recurrent (stage Ⅳ) NSCLC.\n4. Harboring EGFR mutations (including exon19 deletions and exon21 L858R mutation), with documented disease progressed following only one prior line of third-generation EGFR-TKI therapy.\n5. At least one measurable lesion per RECIST v1.1. Lesions previously irradiated cannot serve as target lesions unless definitive progression has occurred in the irradiated lesion.\n6. Patients with asymptomatic brain metastases, or brain metastases whose symptoms have stabilized after treatment.\n7. Laboratory values meeting all of the following criteria:\n\n(1) Hemoglobin ≥100g\u002FL (female), ≥110g\u002FL (male). (2) Absolute neutrophil count ≥1.5×10⁹\u002FL. (3) Platelet count ≥100×10⁹\u002FL. (4) Serum creatinine ≤115 μmol\u002FL, or creatinine clearance (CrCl) ≥60mL\u002Fmin (Cockcroft-Gault formula).\n\n(5) Total bilirubin ≤1.5×upper limit of normal (ULN). (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; or ≤5×ULN for patients with liver metastases.\n\n(7) Albumin ≥30g\u002FL. 8. ECOG PS 0-1. 9. Expected survival ≥3 months. 10. Males with reproductive potential and females of child-bearing potential must agree to use effective contraception from the time of informed consent signing until 3 months after the last study drug administration. For females of child-bearing potential, serum pregnancy test must be negative within 7 days prior to the first study drug dose. Women with surgical sterilization or post-menopausal status are exempted.\n\nExclusion Criteria:\n\n1. Diagnosis of other malignant diseases within 3 years prior to first study drug administration, except for radically treated basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, and\u002For radically resected carcinoma in-situ.\n2. Presence of any of the following genetic alterations: ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon14 skipping mutation, MET amplification, RET fusion, KRAS G12C mutation, HER2 mutation, NRG1 fusion.\n3. Central squamous-cell carcinoma with high risk of massive hemoptysis.\n4. Toxicities from prior anti-tumour therapy have not recovered to Grade≤1, except for alopecia, fatigue and other toxicities judged by the investigator to carry low safety risk.\n5. Prior treatment with sunvozertinib.\n6. Major surgery (e.g., intrathoracic, intra-abdominal or pelvic surgery) within 4 weeks before first study drug administration, or resection for brain metastases within 2 weeks, with incomplete recovery from surgical adverse effects. Thoracoscopic biopsy and mediastinoscopy are not considered major surgery; subjects may be enrolled ≥1week after such procedures. Thoracic\u002Fabdominal effusion drainage and needle biopsy are not regarded as surgery.\n7. Severe or uncontrolled systemic diseases, including but not limited to:\n\n(1) Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite treatment; antihypertensive agents may be initiated or adjusted prior to screening).\n\n(2) Positive HIV antibody; or positive HCV antibody plus positive HCV-RNA; or positive HBsAg with HBV-DNA ≥500 IU\u002FmL. Exception: subjects may be enrolled if HBV-DNA decreases to \\\u003C 500 IU\u002FmL and remains so for ≥2 weeks under antiviral therapy during screening, and antiviral therapy must be continued throughout the study. Subjects who require antiviral therapy at screening or in the past must maintain antiviral therapy for the whole study period.\n\n(3) Active keratitis or ulcerative keratitis. (4) Active tuberculosis. (5) Active infection requiring systemic anti-infective therapy within 2 weeks prior to first study drug administration.\n\n(6) Other severe physical or psychiatric illnesses or laboratory abnormalities that, in the investigators opinion, make study drug inappropriate or compromise protocol compliance.\n\n8\\. Any of the following cardiac conditions:\n\n1. Mean QTcF (QTc corrected by Fridericia formula) from three screening ECGs \\>470 ms at rest.\n2. Significant arrhythmias including ventricular arrhythmias, pharmacologically uncontrolled supraventricular\u002Fnodal arrhythmias and other uncontrolled cardiac arrhythmias (e.g., complete left bundle-branch block, grade III atrioventricular block, grade II atrioventricular block, PR interval \\>250 msec).\n3. Risk factors for QTc interval prolongation: e.g., severe hypokalaemia, congenital long-QT syndrome, concomitant use of QTc-prolonging drugs.\n4. New York Heart Association (NYHA) congestive heart failure class ≥3; left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiogram.\n\n9\\. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid therapy; or ongoing medical intervention or active interstitial lung disease at present.\n\n10\\. Coagulopathy or bleeding diathesis: arterial\u002Fvenous thromboembolic events within 6 months before first study drug administration (including myocardial infarction, unstable angina, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, severe deep-vein thrombosis or other serious thromboembolic events); life-threatening bleeding events requiring transfusion, surgery, local intervention or sustained medical treatment; or tumour invasion of major vessels judged by the investigator to confer high bleeding risk.\n\n11\\. Dysphagia, active gastrointestinal disorders, or history of major gastrointestinal surgery that may substantially impair study-drug ingestion or absorption (e.g., ulcerative lesions, inability to swallow oral medication, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome).\n\n12\\. Pleural, pericardial or peritoneal effusion requiring drainage and\u002For associated with dyspnoea within 4 weeks before first study drug administration.\n\n13\\. Any clinically significant systemic disease requiring treatment as judged by the investigator, including but not limited to thyroid disorders (subjects with stable thyroid function on hormone-replacement therapy are eligible), organ transplantation recipients, psychiatric disorders, history of substance abuse, alcoholism or drug addiction.\n\n14\\. Known hypersensitivity to the active substance or excipients of the study drug.\n\n15\\. Pregnant or lactating females. 16. Currently participating in another investigational drug or device trial, or having received other investigational drugs\u002Fdevices within 2 weeks before first study drug administration.\n\n17\\. Cognitive impairment likely to limit understanding and execution of informed consent.\n\n18\\. Any other conditions that may increase risks related to study-drug administration, confound interpretation of study results, poor subject compliance, or render the subject unsuitable for enrolment as judged by the investigator.",{"count":616,"type":22},34,[26],"This study is a single arm study to access the anti-tumor efficacy and safety of Andamertinib plus Anlotinib in patients with locally advanced or metastatic non-small cell lung cancer previously treated with third-generation EGFR-TKI.",[620],"Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line",[622,623,624,143],"Andamertinib","Anlotinib","Third-generation EGFR-TKI",{"date":35,"type":36},{"date":627,"type":22},"2026-09-30",{"date":629,"type":22},"2029-09-30",{"name":631,"class":430},"Fudan University",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":552,"sex":17,"minAge":639,"maxAge":640,"enrollmentInfo":641,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":66},"100649299","online-fbt-dbt-caregiver-intervention-for-caregivers-of-individuals-with-anorexia-nervosa-100649299","NCT07734779","Online FBT-DBT Caregiver Intervention for Caregivers of Individuals With Anorexia Nervosa","A Randomized Controlled Trial of an Online Family-Based Treatment (FBT) Combined With Dialectical Behavior Therapy (DBT) Intervention Versus Online Supportive Psychological Intervention for Reducing Caregiver Burden Among Caregivers of Individuals With Anorexia Nervosa","Inclusion Criteria:\n\n* Primary caregiver of an individual diagnosed with anorexia nervosa (AN) by a qualified clinician.\n\nThe individual with AN is between 10 and 20 years of age. The individual with AN does not have a severe comorbid physical illness or severe psychiatric disorder.\n\nThe caregiver lives in the same household as the individual with AN. The caregiver has at least a primary school level of education and is able to complete study procedures and questionnaires.\n\nAll participating caregivers from the same family are willing to participate in the intervention and assessment procedures.\n\nAble and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Currently providing care for another family member with a chronic physical illness or psychiatric disorder.\n\nCurrent or past history of a severe physical illness or severe psychiatric disorder that would interfere with study participation.\n\nSevere emotional instability, active self-harm or suicidal behavior, psychotic symptoms, or other psychiatric conditions requiring immediate clinical intervention.\n\nUnable or unwilling to participate in the intervention or assessment procedures.","10 Years","20 Years",{"count":370,"type":22},[289],"Anorexia nervosa (AN) is a severe psychiatric disorder characterized by a chronic and relapsing course. Caregivers of individuals with AN often experience substantial caregiving burden, emotional distress, and impairment in family functioning due to their ongoing responsibilities in meal supervision, treatment support, and symptom management. Despite the critical role of caregivers in treatment and recovery, evidence-based interventions specifically targeting caregiver burden remain limited in China.\n\nThis study aims to develop and evaluate an online intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) for caregivers of individuals with AN. FBT emphasizes empowering caregivers to support nutritional rehabilitation and recovery, whereas DBT provides skills in emotion regulation, validation, and effective communication. The integration of these approaches may help caregivers reduce distress, improve caregiving skills, and enhance family functioning.\n\nThis study will employ a randomized controlled trial design. A total of 80 primary caregivers of individuals with AN will be recruited and randomly assigned to either an online FBT-DBT intervention group or an online supportive psychological intervention group. Both interventions will be delivered in a group format over 12 weeks. Assessments will be conducted at baseline, 4 weeks, 8 weeks, post-intervention (12 weeks), and at 1-month and 3-month follow-up. The primary outcome will be caregiver burden. Secondary outcomes will include psychological distress, negative emotional experiences, and the impact of eating disorder symptoms on the family.\n\nThe study aims to determine the effectiveness of the online FBT-DBT intervention in reducing caregiver burden and psychological distress and to evaluate whether it provides greater benefits than supportive psychological intervention. Findings may contribute to the development of accessible and evidence-based caregiver interventions for families affected by AN in China.",[645,646],"Anorexia Nervosa","Caregiver Burden",{"date":35,"type":36},{"date":649,"type":36},"2026-04-03",{"date":651,"type":22},"2027-01-20",{"name":653,"class":430},"Shanghai Mental Health Center",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":408,"enrollmentInfo":662,"targetDuration":4,"studyType":23,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":677,"locationsCount":66},"100622168","phase-4-anrikefon-vs-nalfurafine-for-sleep-quality-in-hemodialysis-patients-with-ckd-ap-100622168","NCT07380113","Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP","An Exploratory Study Comparing Anrikefon With Nalfurafine in Improving Sleep Quality Among CKD-aP Patients Undergoing Hemodialysis: An Open-Label Randomized Controlled Clinical Trial","Anrikefon","Inclusion Criteria:\n\n1. Be able to understand the procedures and methods of this trial, be willing to strictly follow the clinical research protocol to complete this trial, and voluntarily sign the informed consent form.\n2. Male or female individuals aged 18 or above and 75 or above.\n3. Patients with end-stage renal disease received regular hemodialysis three times a week before the screening period (whether they met the requirements for regular dialysis was determined based on the opinions of the researchers).\n4. Meet the diagnostic criteria for chronic kidney disease-associated pruritus (CKD-aP).\n\n   1. Patients with chronic kidney disease (CKD) presenting with pruritus, with other identifiable causes of pruritus excluded.\n   2. Pruritus occurring on at least 3 days within a 2-week period, with multiple episodes per day, each lasting for several minutes, and having an impact on the patient's daily life.\n   3. Recurrent pruritus persisting for at least 6 weeks.A diagnosis requires that all three criteria above be met simultaneously.\n5. The subjects were evaluated using the Worst Itch Numerical Rating Scale (WI-NRS) for the most severe pruritus intensity and met the baseline pruritus intensity of ≥ 4 points.\n6. The subjects have completed the Pittsburgh Sleep Quality Index (PSQI) assessment during the screening period and met the baseline PSQI score \\> 7 points.\n\nExclusion Criteria:\n\n1. Participants with other serious systemic diseases that may affect their ability to participate in the study, as assessed by the investigator, including but not limited to:\n\n   1. Severe cardiovascular diseases, such as unstable angina, myocardial infarction, severe arrhythmias, World Health Organization (WHO) heart function classification III-IV during screening, poorly controlled hypertension or hypotension despite active treatment, and recurrent asthma.\n   2. A history of cerebrovascular accident (CVA) within the last 6 months.\n   3. Malignant tumors, excluding those that are curable, such as cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, or any other cancer that has been cured (with no evidence of disease recurrence for 5 years).\n2. It is expected to undergo kidney transplantation and\u002For parathyroidectomy during the study period.\n3. The subjects are currently undergoing ultraviolet B treatment or are expected to receive such treatment during the study period.\n4. Have participated in any clinical trials of other drugs or medical devices within one month prior to screening (treatment with drugs or medical devices that have received clinical trials).\n5. Patients who have used the following drugs within 7 days before screening:\n\n   1. those who have used opioids.\n   2. those who must use opioids other than the investigational drug during the study period.\n   3. those who has used gabapentin, pregabalin and calcineurin inhibitors;\n   4. those who use drugs that can affect the efficacy judgment of anti-itching, including but not limited to antipsychotic drugs, sedative-hypnotic drugs, selective serotonin reuptake inhibitors (SSRIs), anti-anxiety drugs, or tricyclic antidepressants.\n6. After screening and enrollment, new antihistamines (such as antihistamines and corticosteroids, etc. (oral, intravenous or topical)) were prescribed, or the types, dosages or frequencies of these drugs were changed.\n7. Patients who have used any hypnotic or sedative medications (including benzodiazepine hypnotics, non-benzodiazepine hypnotics, melatonin receptor agonists, etc.) within 1 month prior to the screening period and baseline assessment.\n8. There is a history of allergy to opioid drugs, or it is known that there is a history of allergy to investigatory drugs or components of remedial drugs or other drugs or excipients with similar chemical structures.\n9. Severe hematological and liver function abnormalities during screening, meeting any one of the following clinical laboratory test results:\n\n   1. Hematology: Hemoglobin \\\u003C 80g\u002FL.\n   2. Liver function:\n\n      * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.5× upper limit of normal (ULN).\n      * Total bilirubin (TBIL) \\> 2×ULN.\n10. Subjects who had any active infections during screening and whom the researchers considered unsuitable for inclusion (including but not limited to acute hepatitis, skin infections, etc.).\n11. As determined by the researchers, any other physical or mental illness or condition that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.",{"count":663,"type":22},50,[372],"The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI). The study will also evaluate the safety of Anruikefen.\n\nThe main questions it aims to answer are:\n\n* Does Anruikefen injection improve sleep quality better than oral nalfurafine?\n* Does Anruikefen injection improve patients' quality of life more than oral nalfurafine? Researchers will compare Anruikefen with nalfurafine (an active control drug) to evaluate differences in their effects on sleep quality in patients with chronic kidney disease-associated pruritus.\n\nParticipants will:\n\n* Receive either Anruikefen injection (0.3 μg\u002Fkg, three times per week) or nalfurafine hydrochloride orally disintegrating tablets (2.5 μg once daily).\n* Continue treatment for 4 weeks, followed by a 1-week safety follow-up.\n* Complete the Pittsburgh Sleep Quality Index and other quality-of-life questionnaires after one month.",[667,668,669,670,671,672],"Pruritus Chronic","Kidney Diseases, Chronic","Renal Insufficiency, Chronic","Uremia; Chronic","Pruritus Due to Systemic Disorder (Disorder)","Pruritus Due to Hemodialysis",{"date":35,"type":36},{"date":675,"type":36},"2026-06-22",{"date":541,"type":22},{"name":678,"class":430},"Zhujiang Hospital",""]