[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602190":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":18,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":18,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":18,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":55,"conditions":65,"keywords":18,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Tislelizumab 400 mg iv, q6w, for up to 1 year; patients are permitted to receive concurrent adjuvant platinum-based doublet chemotherapy (q3w, up to 4 cycles) starting from the first dose of tislelizumab; during concurrent chemotherapy, a tislelizumab dosage of 200 mg iv, q3w is allowed.",[13],"Drug: Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Patients are permitted to receive postoperative adjuvant platinum - based doublet chemotherapy (q3w, up to 4 cycles).",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"DRUG","Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Fengwei Tan","CONTACT","+86 134 3945 7872","tanfengwei@126.com",[31],{"facility":32,"status":33,"city":34,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Chinese Academy of Medical Sciences Cancer Hospital","RECRUITING","Beijing","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":28,"phoneExt":18,"email":29},"Tan",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Zhijie Wang","Chief Physician","100602190","phase-2-study-to-evaluate-the-efficacy-and-safety-of-adjuvant-tislelizumab-in-high-risk-stage-i-nsclc-100602190",false,"NCT07120282","Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC","A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC","Inclusion Criteria:\n\n* Able to provide written informed consent form (ICF) and agree to follow study requirements and assessment schedule.\n* Aged 18 years or older.\n* Histologically confirmed stage I non - small cell lung cancer (AJCC 9th edition), with tumor size 2cm \\\u003C= T \\\u003C=4cm.\n* Postoperative pathological report shows at least one high-risk factor (visceral pleural invasion, lymphovascular invasion, STAS, poorly differentiated status, high-grade invasive adenocarcinoma (any structure + high grade structure \\>=20%, including solid, micropapillary, or complex glands)).\n* ECOG performance status 0 or 1.\n* PD-L1 expression \\>=1%.\n* No EGFR\u002FALK sensitive mutations.\n* Achieved complete resection (R0) .\n* Within 8 weeks after surgery, with full recovery from operation.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Any previous treatment for current lung cancer, including radiotherapy and systemic anti-tumour therapies (chemotherapy, immunotherapy, targeted therapy, anti-angiogenesis therapy, etc.).\n* Prior chest radiotherapy (including lung, oesophageal, mediastinal, or breast cancer).\n* Patients with large - cell neuroendocrine carcinoma (LCNEC) or mixed - subtype non - small - cell lung cancer with small - cell components.\n* With EGFR\u002FALK sensitive mutations.\n* Underwent segmentectomy or wedge resection only.\n* Tumours involving main bronchi, or with obstructive pneumonia\u002Fatelectasis (partial or whole lung).\n* Active autoimmune disease or history of relapsing autoimmune disease.\n* History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis needing hormone therapy, or current active interstitial lung disease, or on relevant treatment\u002Fintervention.\n* Any condition needing systemic corticosteroid (\\> 10 mg\u002Fd prednisone or equivalent) or other immunosuppressant within 14 days before randomisation\n* Used other approved systemic immunomodulators (interferon, interleukin - 2, tumour necrosis factor, thymopentin, thymosin α1, etc.) within 4 weeks before first dose.\n* Herbs used for cancer control within 14 days before first study\n* Live\u002Fattenuated vaccine receipt within 4 weeks before enrollment, or plan to receive during study or within 5 months after last tislelizumab dose.\n* History of significant disease or conditions affecting organ\u002Fsystem function, per investigator's judgment.\n* Severe chronic\u002Factive infection needing systemic antibacterial, antifungal, or antiviral therapy (e.g., tuberculosis) within 14 days before first study-drug dose. ·Known HIV infection.\n* Allogeneic stem - cell\u002Forgan transplant history.\n* Active malignancy within 2 years before enrollment, except the specific cancer studied and locally recurrent cancers cured (e.g., excised basal\u002Fsquamous - cell skin cancer, superficial bladder cancer, cervical\u002F breast carcinoma in situ).\n* Specific conditions and\u002For alcohol\u002Fdrug abuse or dependence that may hinder drug administration, affect outcome interpretation, or increase complication risks.\n* Pregnant\u002Fbreastfeeding women, or men\u002Fwomen planning to conceive during the study.\n* Participation in another interventional clinical study (except observational studies or follow-up phases).","ALL","18 Years",{"count":60,"type":61},108,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2",[66],"Lung Cancer (NSCLC)","2026-03-05",{"date":69,"type":70},"2026-03-09","ACTUAL",{"date":72,"type":70},"2025-10-28",{"date":74,"type":61},"2030-12-31",{"name":5,"class":6},1]