[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511522":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":43,"interventions":50,"overallOfficials":56,"centralContacts":63,"locations":68,"responsibleParty":82,"collaborators":36,"id":84,"slug":36,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":36,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":36,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":70,"whyStopped":36,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Hunan Cancer Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"ORR","Objective response rate","From the initiation of the first dose to 3 years",[14,17,20,23,27,30,33],{"measure":15,"description":16,"timeFrame":12},"PFS","Progression-free survival",{"measure":18,"description":19,"timeFrame":12},"OS","Overall survival",{"measure":21,"description":22,"timeFrame":12},"iORR","Objective response rate after induction therapy",{"measure":24,"description":25,"timeFrame":26},"AEs","Adverse events","From the initiation of the first dose to 90 days after the last dose",{"measure":28,"description":29,"timeFrame":12},"Measurement of Quality of Life with EORTC QLQ-C30 questionnaire","EORTC QLQ-C30 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome",{"measure":31,"description":32,"timeFrame":12},"Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire","EORTC QLQ-LC13 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome",{"measure":34,"description":35,"timeFrame":12},"Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire","The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being \"the worst health you can imagine\" and 100 being \"the best health you can imagine\"",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"NA","SINGLE_GROUP","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"Interventional arm","EXPERIMENTAL","Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.",[49],"Drug: Sugemalimab and Chemotherapy",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":36},"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.",[45],[57,61],{"name":58,"affiliation":59,"role":60},"Hui Wang, MD","the Department of Radiation Oncology","PRINCIPAL_INVESTIGATOR",{"name":62,"affiliation":59,"role":60},"Huai Liu, MD",[64],{"name":62,"role":65,"phone":66,"phoneExt":36,"email":67},"CONTACT","+8619918909231","liuhuai@hnca.org.cn",[69],{"facility":5,"status":70,"city":71,"state":36,"zip":36,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"RECRUITING","Changsha","China","CN",{"type":75,"coordinates":76},"Point",[77,78],112.97087,28.19874,{"lat":78,"lon":77},[81],{"name":62,"role":65,"phone":66,"phoneExt":36,"email":67},{"type":83,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","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":94,"type":95},41,"ESTIMATED","INTERVENTIONAL",[98],"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.",[101],"Carcinoma, Non-Small-Cell Lung",[103,104,105,106,107],"immunotherapy","chemotherapy","radiotherapy","surgery","non-small cell lung cancer","2023-07-07",{"date":110,"type":111},"2023-07-11","ACTUAL",{"date":113,"type":111},"2023-06-14",{"date":115,"type":95},"2026-12",{"name":5,"class":6},1]