[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653993":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":11,"studyPopulation":11,"armGroups":44,"interventions":56,"overallOfficials":11,"centralContacts":70,"locations":11,"responsibleParty":76,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":11,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":11,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":11,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":11},{"fullName":5,"class":6},"Zai Lab (Hong Kong), Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Overall survival of ZL-1310 with IO compared to chemo with IO",null,"up to approximately 3 years",[14,16,18,20,22,24,26,28,30,32,34,36],{"measure":15,"description":11,"timeFrame":12},"Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO",{"measure":17,"description":11,"timeFrame":12},"Confirmed objective response rate (ORR) assessed by BICR and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO",{"measure":19,"description":11,"timeFrame":12},"Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310with IO compared to chemo with IO",{"measure":21,"description":11,"timeFrame":12},"Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO",{"measure":23,"description":11,"timeFrame":12},"Confirmed central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO",{"measure":25,"description":11,"timeFrame":12},"Duration of central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO",{"measure":27,"description":11,"timeFrame":12},"Incidence rate of new brain metastases in participants without baseline brain metastases of ZL-1310 with IO compared to chemo with IO",{"measure":29,"description":11,"timeFrame":12},"Time to first onset of new brain metastases in participants without baseline brain metastases of ZL-130",{"measure":31,"description":11,"timeFrame":12},"Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ-5D-5L index)",{"measure":33,"description":11,"timeFrame":12},"Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ visual analog scale [VAS]).",{"measure":35,"description":11,"timeFrame":12},"Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-LC13",{"measure":37,"description":11,"timeFrame":12},"Changes from baseline in quality of life parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-C30",{"allocation":39,"interventionModel":40,"interventionModelDescription":11,"primaryPurpose":41,"observationalModel":11,"timePerspective":11,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":11,"whoMasked":11},"NONE",[45,50],{"label":46,"type":47,"description":11,"interventionNames":48},"ZL-1310 in Combination with Checkpoint Inhibitor","EXPERIMENTAL",[49],"Combination Product: ZL-1310 in combination with Atezolizumab or Durvalumab",{"label":51,"type":52,"description":11,"interventionNames":53},"Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor","ACTIVE_COMPARATOR",[54,55],"Combination Product: Carboplatin\u002FEtoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin","Combination Product: Carboplatin\u002FEtoposide or Cistplatin\u002FEtoposide in Combination with Durvalumab induction followed by Durvalumab maintenance",[57,62,66],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"COMBINATION_PRODUCT","ZL-1310 in combination with Atezolizumab or Durvalumab","ZL-1310 ADC in combination with checkpoint inhibitor",[46],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":11},"Carboplatin\u002FEtoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin","Platinum-based chemotherapy in combination with a checkpoint inhibitor",[51],{"type":58,"name":67,"description":68,"armGroupLabels":69,"otherNames":11},"Carboplatin\u002FEtoposide or Cistplatin\u002FEtoposide in Combination with Durvalumab induction followed by Durvalumab maintenance","Standard of Care Platinum-based chemotherapy in combination",[51],[71],{"name":72,"role":73,"phone":74,"phoneExt":11,"email":75},"ZL-1310-005 Study Team","CONTACT","650-360-1601","Study-ZL-1310-005@zailaboratory.com",{"type":77,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[79],{"name":80,"class":6},"Zai Lab (US) LLC","100653993","phase-3-a-study-of-zl-1310-in-combination-with-a-checkpoint-inhibitor-versus-standard-of-care-platinum-based-chemotherapy-with-a-checkpoint-inhibitor-as-first-line-therapy-in-participants-with-extensive-stage-small-cell-lung-cancer-100653993",false,"NCT07796100","A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer","A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-drug Conjugate (ADC) in Combination With a Checkpoint Inhibitor Compared to Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed ES-SCLC\n* No prior systemic therapy has been received\n* Medically eligible to receive standard platinum-based chemotherapy with atezolizumab or durvalumab as first-line therapy\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* Life expectancy of at least 3 months\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Has a contraindication to receive atezolizumab or durvalumab according to local drug label or local treatment guideline\n* Participants with symptomatic CNS metastases (require initiation or dose change of steroids or anti-convulsant within 7 days prior to randomization; require steroid dose higher that prednisone 10 mg\u002Fday or equivalent within 14 days prior to randomization\n* History of ILD\u002Fpnuemonitis (non-infectious) that required corticosteroids, current ILD\u002Fpnuemonitis of any grade, or suspected ILD\u002Fpnuemonitis that cannot be ruled out by imaging at screening\n* Received radiotherapy within 2 weeks to the non-thoracic and within 4 weeks to the thoracic area prior to the first dose of study treatment or received more than 30 Gy of thoracic radiotherapy\n* Clinically significant active cardiovascular disease or history of any arterial thromboembolic event within 6 months prior to the first dose of study treatment\n* Clinically severe pulmonary compromise (including but not limited to baseline oxygen saturation of \\\u003C90% on room air) resulting from intercurrent pulmonary illnesses\n* Major surgery within 4 weeks prior to the first dose of study treatment.","ALL","18 Years",{"count":91,"type":92},530,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of ZL-1310 in combination with a checkpoint inhibitor compared to standard first-line therapy in participants with Extensive-Stage Small Cell Lung Cancer.",[98],"Extensive-Stage Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-08-26",{"date":102,"type":103},"2026-08-31","ACTUAL",{"date":105,"type":92},"2026-12-31",{"date":107,"type":92},"2031-06-30",{"name":109,"class":6},"Zai Lab (Shanghai) Co., Ltd."]