[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582836":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":56,"overallOfficials":68,"centralContacts":73,"locations":82,"responsibleParty":339,"collaborators":37,"id":341,"slug":37,"hasResults":342,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":37,"eligibilityCriteria":346,"healthyVolunteers":342,"sex":347,"minAge":348,"maxAge":37,"enrollmentInfo":349,"targetDuration":37,"studyType":352,"phases":353,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":85,"whyStopped":37,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},{"fullName":5,"class":6},"Wayshine Biopharm, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"ORR","proportion of patients with a best overall response of complete response or partial response","every 8 weeks, up to 1 year",[14,17,20,23,27,31,34],{"measure":15,"description":16,"timeFrame":12},"Duration of Response (DoR)","proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression",{"measure":18,"description":19,"timeFrame":12},"PFS","proportion of patients with the time from randomization until the date of objective disease progression or death",{"measure":21,"description":22,"timeFrame":12},"Disease Control Rate (DCR)","the percentage of patients who have a best overall response of CR or PR or SD",{"measure":24,"description":25,"timeFrame":26},"Overall Survival (OS)","the time from the date of randomization until death due to any cause","24 months",{"measure":28,"description":29,"timeFrame":30},"EORTC QLQ-C30 (HRQoL)","PROs will be assessed using the EORTC QLQ-C30,changes in score compared to baseline will be evaluated.","up to 24 months",{"measure":32,"description":33,"timeFrame":30},"EORTC QLQ-LC13 (HRQoL)","PROs will be assessed using the EORTC QLQ-LC13, changes in score compared to baseline will be evaluated.",{"measure":35,"description":36,"timeFrame":30},"PRO CTCAE (HRQoL)","To be assessed using the PRO CTCAE ,changes in symptoms compared to baseline will be evaluated.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+\u002FC797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Dose level A selected from Phase I study","EXPERIMENTAL","BID",[51],"Drug: WSD0922-FU Tablets, Dose level A",{"label":53,"type":48,"description":49,"interventionNames":54},"Dose level B selected from Phase I study",[55],"Drug: WSD0922-FU Tablets, Dose level B",[57,64],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"DRUG","WSD0922-FU Tablets, Dose level A","Oral, 21 days in each cycle",[47],[63],"WSD0922",{"type":58,"name":65,"description":60,"armGroupLabels":66,"otherNames":67},"WSD0922-FU Tablets, Dose level B",[53],[63],[69],{"name":70,"affiliation":71,"role":72},"Adjei Alex A., PhD","The Cleveland 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Hospital","Weston","Florida","33331",{"type":92,"coordinates":108},[109,110],-80.39977,26.10037,{"lat":110,"lon":109},[113],{"name":99,"role":76,"phone":114,"phoneExt":37,"email":115},"866-293-7866","saravid@ccf.org",{"facility":117,"status":85,"city":118,"state":119,"zip":120,"country":89,"countryCode":90,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Karmanos Cancer Institute","Detroit","Michigan","48201",{"type":92,"coordinates":122},[123,124],-83.04575,42.33143,{"lat":124,"lon":123},[127],{"name":99,"role":76,"phone":128,"phoneExt":37,"email":129},"231-487-3390","upretyd@karmanos.org",{"facility":131,"status":85,"city":132,"state":133,"zip":134,"country":89,"countryCode":90,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Hackensack Meridian Health-Southern Ocean Medical Center","Manahawkin","New 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Specialists","Fairfax","Virginia","22031",{"type":92,"coordinates":192},[193,194],-77.30637,38.84622,{"lat":194,"lon":193},[197],{"name":99,"role":76,"phone":198,"phoneExt":37,"email":199},"703-636-1473","Alexander.Spira@USOncology.com",{"facility":201,"status":85,"city":202,"state":203,"zip":204,"country":205,"countryCode":206,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Fujian Provincial Cancer Hospital","Fuzhou","Fujian","350014","China","CN",{"type":92,"coordinates":208},[209,210],119.30611,26.06139,{"lat":210,"lon":209},[213],{"name":99,"role":76,"phone":214,"phoneExt":37,"email":215},"86-0591-83660063","1609305255@qq.com",{"facility":217,"status":85,"city":218,"state":219,"zip":220,"country":205,"countryCode":206,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Wuhan Union 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Pontchaillou","Rennes","Ille-et-Vilaine","35000","France","FR",{"type":92,"coordinates":276},[277,278],-1.67431,48.11109,{"lat":278,"lon":277},[281],{"name":99,"role":76,"phone":282,"phoneExt":37,"email":283},"33-299-284321","herve.lena@chu-rennes.fr",{"facility":285,"status":85,"city":286,"state":287,"zip":288,"country":273,"countryCode":274,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"Centre Hospitalier Universitaire CHU De Limoges","Limoges","New Aquitaine","87042",{"type":92,"coordinates":290},[291,292],1.24759,45.83362,{"lat":292,"lon":291},[295],{"name":99,"role":76,"phone":296,"phoneExt":37,"email":297},"33-555055555","Thomas.Egenod@chu-limoges.fr",{"facility":299,"status":85,"city":300,"state":287,"zip":301,"country":273,"countryCode":274,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"CHU Bordeaux - Centre Francois Magendie","Pessac","33604",{"type":92,"coordinates":303},[304,305],-0.6324,44.80565,{"lat":305,"lon":304},[308],{"name":99,"role":76,"phone":309,"phoneExt":37,"email":310},"33-557656338","remi.veillon@chu-bordeaux.fr",{"facility":312,"status":85,"city":313,"state":314,"zip":315,"country":273,"countryCode":274,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"Centre Francois Baclesse","Caen","Normandy","14000",{"type":92,"coordinates":317},[318,319],-0.35912,49.18585,{"lat":319,"lon":318},[322],{"name":99,"role":76,"phone":323,"phoneExt":37,"email":324},"33-231455050","h.curcio@baclesse.unicancer.fr",{"facility":326,"status":85,"city":327,"state":328,"zip":329,"country":273,"countryCode":274,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"CHU Toulon - Hopital Sainte Musse","Toulon","Var","83100",{"type":92,"coordinates":331},[332,333],5.92836,43.12442,{"lat":333,"lon":332},[336],{"name":99,"role":76,"phone":337,"phoneExt":37,"email":338},"33-494145000","clarisse.audigier-valette@ch-toulon.fr",{"type":340,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100582836",false,"NCT06868485","A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer","A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation","Inclusion criteria:\n\n* Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.\n* Male or female aged ≥18 years old.\n* Histological or cytological confirmation diagnosis of NSCLC.\n* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.\n* Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.\n* Documented EGFR mutation .\n* Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.\n* At least one lesion, not previously irradiated and not chosen for biopsy during the study.\n* Females should have evidence of non-childbearing potential.\n\nExclusion criteria:\n\n* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.\n* Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.\n* Symptomatic brain complications that require urgent neurosurgical or medical intervention.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.\n* Past medical history of ILD.\n* Inadequate bone marrow reserve or organ function as demonstrated.\n* Males and females of reproductive potential.\n* Known intracranial hemorrhage which is unrelated to tumor.\n* Seizures requiring a change in anti-epileptic medications.","ALL","18 Years",{"count":350,"type":351},40,"ESTIMATED","INTERVENTIONAL",[354],"PHASE2","This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.",[357],"Non Small Cell Lung Cancer",[359,360,361,362,363],"C797S","BM","WSD0922-FU","NSCLC","EGFR","2025-08-30",{"date":366,"type":367},"2025-09-08","ACTUAL",{"date":369,"type":367},"2025-08-18",{"date":371,"type":351},"2027-12-31",{"name":5,"class":6},18]