[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587438":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":34,"interventions":45,"overallOfficials":57,"centralContacts":62,"locations":68,"responsibleParty":83,"collaborators":22,"id":85,"slug":22,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":22,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":22,"overallStatus":70,"whyStopped":22,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Akeso","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Survival (OS)","Overall Survival (OS) in the FAS population","approximately 5 years",[14,18],{"measure":15,"description":16,"timeFrame":17},"Progression Free Survival (PFS)","Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1","approximately 3 years",{"measure":19,"description":20,"timeFrame":21},"Adverse Event (AE)","Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results","From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":29},"QUADRUPLE",[30,31,32,33],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[35,40],{"label":36,"type":37,"description":22,"interventionNames":38},"Ivonescimab and docetaxel","EXPERIMENTAL",[39],"Drug: Ivonescimab, docetaxel",{"label":41,"type":42,"description":22,"interventionNames":43},"Placebo and docetaxel","ACTIVE_COMPARATOR",[44],"Drug: Placebo, docetaxel",[46,53],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","Ivonescimab, docetaxel","Patients will receive ivonescimab and docetaxel as an IV injection",[36],[52],"AK112, docetaxel",{"type":47,"name":54,"description":55,"armGroupLabels":56,"otherNames":22},"Placebo, docetaxel","Patients will receive placebo and docetaxel as an IV injection",[41],[58],{"name":59,"affiliation":60,"role":61},"Caicun Zhou","Shanghai East Hospital","PRINCIPAL_INVESTIGATOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":22,"email":67},"Wenting Li","CONTACT","18116403289","wenting01.li@akesobio.com",[69],{"facility":60,"status":70,"city":71,"state":72,"zip":22,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":76,"coordinates":77},"Point",[78,79],121.45806,31.22222,{"lat":79,"lon":78},[82],{"name":59,"role":65,"phone":22,"phoneExt":22,"email":22},{"type":84,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100587438",false,"NCT06928389","Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer","A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy","NSCLC","Inclusion Criteria:\n\n* Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).\n* Age ≥ 18 years old and ≤ 75 years old at the time of randomization.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected life expectancy of at least 3 months.\n* Histologically or cytologically confirmed diagnosis of NSCLC.\n* Locally advanced or metastatic NSCLC (American Joint Committee on Cancer \\[AJCC\\] 8th edition).\n* Previously received systemic platinum-based chemotherapy and PD-1\u002FL1 inhibitors.\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.\n* Other malignancies within 3 years prior to randomization.\n* Known actionable genomic alterations.\n* Prior administration of any immunotherapy targeting immune mechanisms other than PD-1\u002FPD-L1 inhibitors.\n* Previous treatment with docetaxel.\n* History of severe bleeding tendency or coagulation dysfunction.\n* Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.\n* History of myocarditis, cardiomyopathy, and malignant arrhythmia.","ALL","18 Years","75 Years",{"count":96,"type":97},536,"ESTIMATED","INTERVENTIONAL",[100],"PHASE3","This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.",[103],"Non-Small Cell Lung Cancer","2026-04-07",{"date":106,"type":107},"2026-04-09","ACTUAL",{"date":109,"type":107},"2025-07-08",{"date":111,"type":97},"2030-06",{"name":5,"class":6},1]