[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639125":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":11,"locations":25,"responsibleParty":45,"collaborators":11,"id":47,"slug":11,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SCTB41+docetaxel","EXPERIMENTAL",null,[13,14],"Drug: SCTB41","Drug: docetaxel",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","SCTB41","SCTB41 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"docetaxel","docetaxel is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle",[9],[26],{"facility":27,"status":11,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology","Wuhan","Hubei","430030","China","CN",{"type":34,"coordinates":35},"Point",[36,37],114.26667,30.58333,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Zhe Huang","CONTACT","+86-010-58628288","zhe_huang@sinocelltech.com",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639125",false,"NCT07609251","A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer（Phase II Study Ongoing）","A Phase II\u002FIII Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. ECOG 0-1;\n3. Survival duration more than 3 months;\n4. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent\u002Fsequential chemoradiotherapy;\n5. Without AGA: Have experienced disease progression during or after prior treatment with PD-(L)1 inhibitors and chemotherapy.With AGA: Must have received adequate targeted therapy; EGFR-positive patients must have received prior treatment with PD-(L)1\u002FVEGF bispecific antibody and\u002For TROP-2 ADC;\n6. At least one measurable non-brain lesion according to RECIST v1.1;\n7. Adequate major organ function.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed presence of small cell carcinoma components;\n2. Prior treatment with docetaxel;\n3. Symptomatic central nervous system (CNS) metastases;\n4. Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;\n5. Imaging findings at screening show tumor invasion into major blood vessels or surrounding vital organs, or the presence of a risk of esophagotracheal or esophagopleural fistula, which the investigator assesses as unsuitable for enrollment;\n6. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy;\n7. Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse;\n8. Bleeding tendency, high risk of bleeding, or coagulation disorders;\n9. Diagnosis of another malignancy;\n10. Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose;\n11. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n12. History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease;\n13. Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody;\n15. Pregnant or breastfeeding women;\n16. Any other condition that the investigator considers inappropriate for enrollment.","ALL","18 Years",{"count":56,"type":57},90,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.",[63],"NSCLC (Advanced Non-small Cell Lung Cancer)","NOT_YET_RECRUITING","2026-05-19",{"date":67,"type":68},"2026-05-27","ACTUAL",{"date":70,"type":57},"2026-05",{"date":72,"type":57},"2029-07",{"name":5,"class":6},1]