[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606135":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":11,"armGroups":35,"interventions":57,"overallOfficials":11,"centralContacts":74,"locations":80,"responsibleParty":95,"collaborators":11,"id":97,"slug":11,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":11,"eligibilityCriteria":101,"healthyVolunteers":98,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":11,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":11,"overallStatus":83,"whyStopped":11,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Shenyang Sunshine Pharmaceutical Co., LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Objective response rate (ORR)",null,"12 months",{"measure":14,"description":11,"timeFrame":12},"Incidence and severity of Adverse Events",[16,18,21,23,26],{"measure":17,"description":11,"timeFrame":12},"DCR : Disease Control Rate",{"measure":19,"description":11,"timeFrame":20},"PFS：Progression-Free Survival","24 month",{"measure":22,"description":11,"timeFrame":20},"OS：Overall Survival",{"measure":24,"description":11,"timeFrame":25},"The blood concentration of SSGJ-706","Approximately 6 months",{"measure":27,"description":11,"timeFrame":25},"The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)",{"allocation":29,"interventionModel":30,"interventionModelDescription":11,"primaryPurpose":31,"observationalModel":11,"timePerspective":11,"maskingInfo":32},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":11,"whoMasked":11},"NONE","This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.",[36,41,44,48,52],{"label":37,"type":38,"description":11,"interventionNames":39},"dose level 1 of SSGJ-706 monotherapy","EXPERIMENTAL",[40],"Drug: SSGJ-706",{"label":42,"type":38,"description":11,"interventionNames":43},"dose level 2 of SSGJ-706 monotherapy",[40],{"label":45,"type":38,"description":11,"interventionNames":46},"dose level 1 of SSGJ-706 combined with chemotherapy",[40,47],"Drug: pemetrexed \u002Fcarboplatin",{"label":49,"type":38,"description":11,"interventionNames":50},"dose level 2 of SSGJ-706 combined with chemotherapy",[40,51],"Drug: Carboplatin\u002FPaclitaxel",{"label":53,"type":54,"description":11,"interventionNames":55},"PD-1\u002FL1 combined with chemotherapy","ACTIVE_COMPARATOR",[56],"Drug: PD-1 Inhibitor + Chemotherapy",[58,63,67,70],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"DRUG","SSGJ-706","PD-1\u002FPD-L1 bispecific antibody",[45,37,49,42],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":11},"pemetrexed \u002Fcarboplatin","chemotherapy",[45],{"type":59,"name":68,"description":65,"armGroupLabels":69,"otherNames":11},"Carboplatin\u002FPaclitaxel",[49],{"type":59,"name":71,"description":72,"armGroupLabels":73,"otherNames":11},"PD-1 Inhibitor + Chemotherapy","control group",[53],[75],{"name":76,"role":77,"phone":78,"phoneExt":11,"email":79},"Shengxiang Ren","CONTACT","13816756732","harry_ren@126.com",[81],{"facility":82,"status":83,"city":84,"state":11,"zip":11,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Institute of The Shanghai Pulmonary Hospital","RECRUITING","Shanghai","China","CN",{"type":88,"coordinates":89},"Point",[90,91],121.45806,31.22222,{"lat":91,"lon":90},[94],{"name":76,"role":77,"phone":78,"phoneExt":11,"email":79},{"type":96,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100606135",false,"NCT07171606","A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients","Inclusion Criteria:\n\n1. Males and\u002For females over age 18\n2. Histologically and\u002For cytologically documented local advanced or metastatic NSCLC .\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Expected survival \\>=3 months.\n5. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Known uncontrolled or symptomatic central nervous system metastatic disease.\n2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \\>1 (National Cancer Institute Common terminology Criteria \\[NCI CTCAE\\] v.5.0).\n3. Inadequate organ or bone marrow function.\n4. Pregnant or breast-feeding woman.\n5. Known allergies, hypersensitivity, or intolerance to SSGJ-706\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years","75 Years",{"count":106,"type":107},240,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC",[113],"First-line Advanced NSCLC Patients","2025-12-10",{"date":116,"type":117},"2025-12-18","ACTUAL",{"date":119,"type":117},"2025-10-24",{"date":121,"type":107},"2027-08-31",{"name":5,"class":6},1]