[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647902":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":24,"locations":46,"responsibleParty":118,"collaborators":24,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":24,"maxAge":24,"enrollmentInfo":128,"targetDuration":24,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":24,"overallStatus":143,"whyStopped":24,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Substudy A (Selumetinib)","EXPERIMENTAL","Subjects will receive selumetinib 25 mg\u002Fm² by mouth twice daily (single dose not to exceed 50 mg) for up to 12 cycles (28 days per cycle).",[13],"Drug: Selumetinib 25mg\u002Fm2",{"label":15,"type":10,"description":16,"interventionNames":17},"Substudy B (Luvometinib + Serplulimab)","Subjects will receive luvometinib 8 mg by mouth once daily in combination with serplulimab 4.5 mg\u002Fkg intravenously every 3 weeks for up to 12 cycles (28 days per cycle).",[18,19],"Drug: Luvometinib","Drug: Serplulimab",{"label":21,"type":22,"description":23,"interventionNames":24},"Natural History Cohort","NO_INTERVENTION","Participants who are not eligible for any active treatment substudy, or who choose not to receive investigational therapy, will remain in the Natural History Observation Arm. No study intervention will be administered. Participants will undergo standardized longitudinal clinical, imaging, and outcome assessments according to the master protocol. Data collected from this arm will be used to characterize the natural history of NF2-related schwannomatosis and will serve as a shared observational comparator for active treatment arms within the platform.",null,[26,34,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Selumetinib 25mg\u002Fm2","Oral twice daily per predetermined dosage per protocol.",[9],[32,33],"Koselugo","AZD6244",{"type":27,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Luvometinib","Oral once daily per predetermined dosage per protocol.",[15],[39],"FCN-159",{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Serplulimab","Intravenous infusion per predetermined dosage per protocol.",[15],[45],"HLX10",[47,66,77,88,103],{"facility":48,"status":24,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Xuanwu Hospital, Capital Medical University","Beijing","Beijing Municipality","100053","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61],{"name":62,"role":63,"phone":64,"phoneExt":24,"email":65},"Hao Wu, PhD","CONTACT","+86 10-83922345","wuhaospine@xwh.ccmu.edu.cn",{"facility":67,"status":24,"city":49,"state":50,"zip":68,"country":52,"countryCode":53,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Beijing Tiantan Hospital, Capital Medical University","100070",{"type":55,"coordinates":70},[57,58],{"lat":58,"lon":57},[73],{"name":74,"role":63,"phone":75,"phoneExt":24,"email":76},"Pinan Liu, PhD","86+ 10-59976611","pinanliu@ccmu.edu.cn",{"facility":78,"status":24,"city":49,"state":50,"zip":79,"country":52,"countryCode":53,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"Chinese PLA General Hospital","100853",{"type":55,"coordinates":81},[57,58],{"lat":58,"lon":57},[84],{"name":85,"role":63,"phone":86,"phoneExt":24,"email":87},"Jun Zhang, PhD","86+ 10-68182255","junzhang301@163.com",{"facility":89,"status":24,"city":90,"state":91,"zip":92,"country":52,"countryCode":53,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"The First Hospital of Jilin University","Changchun","Jilin","130021",{"type":55,"coordinates":94},[95,96],125.32278,43.88,{"lat":96,"lon":95},[99],{"name":100,"role":63,"phone":101,"phoneExt":24,"email":102},"Yunqian Li, PhD","86+ 431-88782222","yunqian@jlu.edu.cn",{"facility":104,"status":24,"city":105,"state":106,"zip":107,"country":52,"countryCode":53,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Shanghai General Hospital","Shanghai","Shanghai Municipality","200080",{"type":55,"coordinates":109},[110,111],121.45806,31.22222,{"lat":111,"lon":110},[114],{"name":115,"role":63,"phone":116,"phoneExt":24,"email":117},"Meiqing Lou, PhD","+86 21-63846590","loumq68128@hotmail.com",{"type":119,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100647902","phase-2-platform-research-for-innovative-medicines-in-nf2-swn-prime-nf2-100647902",false,"NCT07713745","Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2)","PRIME-NF2","Eligibility Specific For MASTER STUDY\n\nInclusion Criteria:\n\nSubjects must satisfy all of the following criteria to be enrolled into the main study natural history observation cohort:\n\n(1) Must meet the 2022 International Consensus Criteria for NF2-SWN, defined by having at least one of the following:\n\n1. Bilateral vestibular schwannomas (VS)\n2. An identical NF2 pathogenic variant in at least 2 anatomically distinct NF2-related tumors (schwannoma, meningioma, and\u002For ependymoma). (Note: if the variant allele fraction (VAF) in unaffected tissues such as blood is clearly \\\u003C50%, the diagnosis is mosaic NF2-related schwannomatosis)\n3. Either 2 major or 1 major and 2 minor criteria as described in the following:\n\nMajor criteria:\n\n* Unilateral VS\n* First-degree relative other than sibling with NF2-related schwannomatosis\n* 2 or more meningiomas (Note: single meningioma qualifies as minor criteria).\n* NF2 pathogenic variant in an unaffected tissue such as blood (Note: if the VAF is clearly \\\u003C50%, the diagnosis is mosaic NF2-related schwannomatosis)\n\nMinor criteria:\n\nCan count \\>1 of a type (eg, 2 distinct schwannomas would count as 2 minor criteria)\n\n* Ependymoma, meningioma (Note: multiple meningiomas qualify as a major criteria), schwannoma (Note: if the major criterion is unilateral VS, at least 1 schwannoma must be dermal in location) Can count only once (eg, bilateral cortical cataracts count as a single minor criterion)\n* Juvenile subcapsular or cortical cataract, retinal hamartoma, epiretinal membrane in a person aged \\\u003C40 years, meningioma\n\n  (2) Presence of at least one evaluable lesion: Vestibular schwannoma, meningioma, or non-vestibular schwannoma: clearly identifiable lesion on contrast-enhanced T1-weighted MRI; Ependymoma: clearly identifiable lesion on contrast-enhanced T1-weighted or T2\u002FFLAIR sequences; (3) Expected ability to complete at least 12 months of follow-up assessments; (4) Ability to understand and voluntarily sign a written informed consent form, or a legally authorized guardian signs the informed consent form together ; (5) Sub-study-specific criteria (for intervention arms only): If the subject intends to enter an interventional sub-study, in addition to meeting the above main study criteria, the subject must also satisfy the specific inclusion criteria specified in that sub-study protocol (e.g., organ function, prior treatment restrictions, washout periods, etc.), as determined by the drug characteristics.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will not be permitted to enter the main study:\n\n1. Coexisting other genetic syndromes that may cause multiple intracranial tumors (e.g., SMARCB1\u002FLZTR1-related schwannomatosis, Cowden syndrome);\n2. Expected survival \\\u003C12 months;\n3. Presence of severe psychiatric disorders or cognitive impairment that precludes cooperation with imaging or hearing assessments;\n4. Extreme social or geographic factors that, in the investigator's judgment, may impede follow-up for more than 12 months;\n5. Sub-study-specific exclusion criteria (for intervention arms only): If the subject intends to enter an interventional sub-study, the subject must also satisfy the specific exclusion criteria specified in that sub-study protocol (e.g., specific organ dysfunction, active infection, pregnancy, etc.).","ALL",{"count":129,"type":130},200,"ESTIMATED","INTERVENTIONAL",[133],"PHASE2","This is an adaptive platform-basket trial that aims to evaluate the safety and efficacy of multiple novel agents and combination therapies in patients with NF2-related schwannomatosis (NF2-SWN). The study employs a basket design to assess treatment responses across four tumor types commonly associated with NF2-SWN: vestibular schwannomas, non-vestibular schwannomas, meningiomas, and ependymomas.\n\nA shared natural history observational cohort, receiving routine clinical follow-up without investigational treatment, serves as a common control for all substudies. The adaptive platform enables the dynamic addition or closure of substudies based on interim analyses, thereby optimizing trial efficiency.\n\nEligible patients who meet the master protocol criteria and satisfy substudy-specific safety requirements will be assigned to receive the corresponding intervention. Currently open substudies include:\n\n* Substudy A: Selumetinib\n* Substudy B: Luvometinib plus Serplulimab",[136,137,138,139,140,141,142],"Neurofibromatosis Type 2","Vestibular Schwannoma","Non-vestibular Schwannoma","Meningioma","Ependymoma","NF2-related Schwannomatosis","NF2","NOT_YET_RECRUITING","2026-07-14",{"date":146,"type":147},"2026-07-20","ACTUAL",{"date":149,"type":130},"2026-07-18",{"date":151,"type":130},"2036-12-31",{"name":5,"class":6},5]