[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525593":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":62,"collaborators":43,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":43,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":43,"enrollmentInfo":73,"targetDuration":43,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},{"fullName":5,"class":6},"3D Medicines","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Envalfolimab plus platinum-based doublet chemotherapy","EXPERIMENTAL","Envalfolimab plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), Envafolimab will be administered after surgery at 600 mg every 3 weeks(Q3W) for 16 cycles at most.",[13],"Drug: Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo plus platinum-based doublet chemotherapy","ACTIVE_COMPARATOR","Placebo plus platinum-based doublet chemotherapy for a total of 3-4 cycles of neoadjuvant therapy (determined by the investigator), placebo will be administered after surgery every 3 weeks(Q3W) for 16 cycles at most.",[19],"Drug: placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Envalfolimab subcutaneously injected+Platinum-based doublet chemotherapy intravenous injection","The subjects receive Envafolimab\u002Fplacebo treatment with a dosage of 600 mg\u002F3 ml subcutaneously injected every 3 weeks.It will last about 3-4 cycles before surgery and 16 cycles after surgery.",[9],[27],"Experimental",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"placebo subcutaneously injected +Platinum-based doublet chemotherapy intravenous injection","The subjects received platinum-based doublet chemotherapy on day 1 of every cycle. It's 3 weeks per cycle and lasts 3-4 cycles before surgery.",[15],[33],"Active Comparator",[35],{"name":36,"affiliation":37,"role":38},"Changli Wang","Tianjin Cancer Hospital","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","0086-22-2340123",null,"Wangchangli@tjmuch.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Tianjin cancer hospital","RECRUITING","Tianjin","Tianjin Municipality","300060","China","CN",{"type":55,"coordinates":56},"Point",[57,58],117.17667,39.14222,{"lat":58,"lon":57},[61],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},{"type":63,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100525593","phase-3-phase-iii-study-of-envafolimab-versus-placebo-plus-chemotherapy-in-resectable-stage-iii-nsclc-100525593",false,"NCT06123754","Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC","A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Volunteer to participate and sign the informed consent form.\n2. Age ≥ 18 years old, regardless of gender.\n3. Histological and\u002For cytological diagnosis of resectable stage IIIA-IIIB (N2) NSCLC.\n4. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1（RECIST 1.1）.\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n6. Subjects should provide tumor tissue for detection of PD-L1 expression level.\n7. Sufficient organ and bone marrow function.\n8. Expected survival ≥6 months.\n9. The surgeon assessed that total lung function is able to withstand the proposed pneumonectomy procedure.\n\nExclusion Criteria:\n\n1. Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous\u002Fsarcomatoid lesions, or adenosquamous carcinoma, or special pathological types.\n2. Previous treatment with another drug that targets T cell receptors (e.g. CTLA-4, OX-40, etc.);\n3. Participants with known EGFR mutation or ALK translocation, and non-squamous cell carcinoma subjects need to identify EGFR and ALK mutation status;\n4. Upper lung sulcus tumor or locally advanced unresectable or metastatic disease.\n5. Previous anti-tumor therapy for the disease.\n6. Subjects with known or suspected interstitial pneumonia.Radiation pneumonia or other moderate to severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function.\n7. Any serious active infection.\n8. With uncontrolled or significant cardiovascular and cerebrovascular disease.\n9. Active autoimmune disease requiring systemic treatment.\n10. Immunosuppressant or systemic hormone therapy (dose \\>10 mg\u002F day prednisone or other therapeutic hormone) for immunosuppression within 14 days prior to randomization.","ALL","18 Years",{"count":74,"type":75},390,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant\u002Fadjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.",[81],"Non-small Cell Lung Cancer",[83],"Envafolimab","2026-03-23",{"date":86,"type":87},"2026-03-25","ACTUAL",{"date":89,"type":87},"2023-11-17",{"date":91,"type":75},"2027-12-30",{"name":93,"class":6},"3D Medicines (Sichuan) Co., Ltd.",1]