[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531084":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":44,"overallOfficials":54,"centralContacts":59,"locations":70,"responsibleParty":93,"collaborators":28,"id":96,"slug":28,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":28,"studyType":109,"phases":110,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":73,"whyStopped":28,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Sichuan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR)","To assess sunvozertinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)","Time from first dose to last dose, or up to 24 month",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Duration of Response (DoR)","To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death","Time from first subject dose to study completion, or up to 36 month",{"measure":19,"description":20,"timeFrame":17},"Progression-free survival (PFS)","To assess progression-free survival of patients treated by sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause",{"measure":22,"description":23,"timeFrame":17},"Overall survival (OS)","To assess overall survival, define as first dose to the death of the subject due to any cause",{"measure":25,"description":26,"timeFrame":27},"Adverse events (AEs) according to CTCAE 5.0","Number of participants with adverse events (AEs) according to CTCAE 5.0","From first dose until 28 days after the last dose, up to 24 month",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NA","SINGLE_GROUP","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","This study is a single arm study to access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)","EXPERIMENTAL","Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)",[42,43],"Drug: Sunvozertinib","Drug: Chemotherapy",[45,50],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":28},"DRUG","Sunvozertinib","Sunvozertinib 200mg Quaquedie (QD)",[38],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":28},"Chemotherapy","Pemetrexed +platinum",[38],[55],{"name":56,"affiliation":57,"role":58},"You Lu, MD","West China Hospital","PRINCIPAL_INVESTIGATOR",[60,66],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Li Li, BA","CONTACT","113880343287","+86","tracy.li_2010@hotmail.com",{"name":67,"role":62,"phone":68,"phoneExt":64,"email":69},"Feifei Na, MD","18583988151","nafeifei@foxmail.com",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"West China Hospital of Sichuan University","RECRUITING","Chengdu","Sichuan","610044","China","CN",{"type":80,"coordinates":81},"Point",[82,83],104.06667,30.66667,{"lat":83,"lon":82},[86,89,90,91],{"name":56,"role":62,"phone":87,"phoneExt":28,"email":88},"+8602885423571","radyoulu@hotmali.com",{"name":67,"role":62,"phone":68,"phoneExt":28,"email":69},{"name":56,"role":58,"phone":28,"phoneExt":28,"email":28},{"name":67,"role":92,"phone":28,"phoneExt":28,"email":28},"SUB_INVESTIGATOR",{"type":58,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"You Lu","Chair of Department of Thoracic Oncology","100531084",false,"NCT06195189","Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I\u002FII","Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I\u002FII (WU-KONG36)","WU-KONG36","Inclusion Criteria:\n\n1. To provide a signed and dated, written informed consent.\n2. 80≥Age ≥ 18 years old\n3. Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory\n4. EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.\n5. Predicted life expectancy ≥ 12 weeks\n6. EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.\n7. No previous systemic chemotherapy for advanced or metastatic disease.\n8. Adequate organ system function:\n9. Patient must have measurable disease according to RECIST 1.1.\n10. Patients with stable or pre-treated brain metastasis (BM) can be enrolled\n\nExclusion Criteria:\n\n1. Spinal cord compression or meningeal metastasis\n2. A history of malignant tumors within 2 years.\n3. With known resistant mutations that have approved target therapy\n4. Recover from AEs caused by previous treatment\n5. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.\n6. Any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency (HIV)","ALL","18 Years","80 Years",{"count":107,"type":108},40,"ESTIMATED","INTERVENTIONAL",[111,112],"PHASE1","PHASE2","To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.",[115],"Non Small Cell Lung Cancer",[115,47,117,118],"EGFR","chemotherapy","2026-05-04",{"date":121,"type":122},"2026-05-08","ACTUAL",{"date":124,"type":122},"2024-02-29",{"date":126,"type":108},"2028-12-30",{"name":5,"class":6},1]