[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606846":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":62,"collaborators":41,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":41,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":41,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":41,"overallStatus":46,"whyStopped":41,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Bio-Thera Solutions","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BAT3306","EXPERIMENTAL","Once every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).",[13],"Drug: BAT3306",{"label":15,"type":16,"description":11,"interventionNames":17},"US-Keytruda® arm","ACTIVE_COMPARATOR",[18],"Drug: US-Keytruda®",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","One vial of 4 mL of concentrate contains 100 mg of BAT3306",[9],[25],"Pembrolizumab Injection",{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"US-Keytruda®","One vial of 4 mL of concentrate contains 100 mg of pembrolizumab",[15],[25],[32],{"name":33,"affiliation":34,"role":35},"Xiaorong Dong, Dr.","Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Yu Sun","CONTACT","86-15040223137",null,"yusun@bio-thera.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":41,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Union Hospital Tongji Medical College Huazhong University of Science & Technology","RECRUITING","Wuhan","Hubei","China","CN",{"type":52,"coordinates":53},"Point",[54,55],114.26667,30.58333,{"lat":55,"lon":54},[58,61],{"name":33,"role":39,"phone":59,"phoneExt":41,"email":60},"86+13986252286","xhzzdxr@126.com",{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"type":63,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100606846","phase-1-a-study-evaluating-bat3306-compared-with-keytruda-in-nsclc-cancer-participants-100606846",false,"NCT07180862","A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants","A Phase 1, Randomized, Double-blind Study to Compare the Pharmacokinetics, Between BAT3306 and Keytruda® (Pembrolizumab) in Participants With Stage IB-IIIA Non-small Cell Lung Cancer Following Complete Resection","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);\n  2. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures;\n  3. Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided;\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria will be excluded from the study:\n\n  1. Presence of EGFR gene mutation;\n  2. Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;\n  3. Have previously received any of the following treatments:\n\n     Have received \\> 4 cycles of adjuvant chemotherapy. Prior neoadjuvant therapy. Major surgery within 4 weeks prior to randomization (including surgery for the primary neoplasm, but excluding vascular access procedures), or expected to undergo major surgery during the study.\n\n     Use of Chinese herbal medicine with anti-tumor indications within 14 days prior to randomization.\n\n     Use of growth factor support therapy or have received a transfusion within 14 days prior to randomization.\n  4. Prior treatment with anti-PD-1, anti-PD-L1\u002F2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.\n  5. Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;","ALL","18 Years","75 Years",{"count":75,"type":76},140,"ESTIMATED","INTERVENTIONAL",[79],"PHASE1","Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment",[82],"Carcinoma, Non-Small-Cell Lung","2025-12-31",{"date":85,"type":86},"2026-01-06","ACTUAL",{"date":88,"type":86},"2025-10-14",{"date":90,"type":76},"2027-11-30",{"name":5,"class":6},1]