[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511522":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":33,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Hunan Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional arm","EXPERIMENTAL","Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.",[13],"Drug: Sugemalimab and Chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sugemalimab and Chemotherapy","Chemotherapy: Paclitaxel 175mg\u002Fm2 D1, Carboplatin AUC=5 or DDP 75mg\u002Fm2 D1 for NSCLC; Pemetrexed 500mg\u002Fm2 D1, Carboplatin AUC=5 or DDP 75mg\u002Fm2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles.\n\nSugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Hui Wang, MD","the Department of Radiation Oncology","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Huai Liu, MD",[29],{"name":27,"role":30,"phone":31,"phoneExt":20,"email":32},"CONTACT","+8619918909231","liuhuai@hnca.org.cn",[34],{"facility":5,"status":35,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Changsha","China","CN",{"type":40,"coordinates":41},"Point",[42,43],112.97087,28.19874,{"lat":43,"lon":42},[46],{"name":27,"role":30,"phone":31,"phoneExt":20,"email":32},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100511522","phase-2-a-trial-of-sugemalimab-and-chemotherapy-in-unresectable-stage-iii-nsclc-100511522",false,"NCT05940532","A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC","A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1.18 to 75 years old, both male and female;\n\n2.ECOG score: 0-1;\n\n3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;\n\n4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;\n\n5.Measurable lesions available;\n\n6.Major organ function is basically normal;\n\n7.Estimated survival time is at least 6 months;\n\n8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed SCLC and NSCLC;\n2. Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);\n3. Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;\n4. Previous thoracic radiotherapy;\n5. Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;\n6. Systemic immunostimulant therapy before the first dose;\n7. Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;\n8. Subjects with autoimmune diseases;\n9. Other malignant tumors other than non-small cell lung cancer within 5 years before screening;\n10. Known or suspected interstitial pneumonia;\n11. Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;\n12. Severe cardiovascular and cerebrovascular diseases;\n13. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;\n14. Arteriovenous thrombotic events within 3 months before the first dose;\n15. Positive HIV test;\n16. Active hepatitis B or C;\n17. Evidence of active tuberculosis infection within 1 year before the first dose;\n18. Serious infection within 4 weeks before the first dose;\n19. History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;\n20. Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;\n21. Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;\n22. History of severe allergic reactions to other monoclonal antibodies\u002Ffusion proteins;\n23. Allergic to any component of the randomized treatment regimen;\n24. Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;\n25. Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;\n26. Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.","ALL","18 Years","75 Years",{"count":60,"type":61},41,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.",[67],"Carcinoma, Non-Small-Cell Lung",[69,70,71,72,73],"immunotherapy","chemotherapy","radiotherapy","surgery","non-small cell lung cancer","2023-07-07",{"date":76,"type":77},"2023-07-11","ACTUAL",{"date":79,"type":77},"2023-06-14",{"date":81,"type":61},"2026-12",{"name":5,"class":6},1]