[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549741":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":45,"locations":50,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":26,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Shanghai Chest Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Participants receive SBRT for primary lung tumor, sequential receive totally 4 cycles of Toripalimab combined with platinum doublet chemotherapy during perioperative period ; participants receive consolidation therapy of Toripalimab Intervention: SBRT: 24Gy\u002F3fractions; Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab",[13,14],"Radiation: SBRT","Drug: Toripalimab",{"label":16,"type":17,"description":18,"interventionNames":19},"Active Comparator","ACTIVE_COMPARATOR","Participantsreceive totally 4 cycles of Toripalimab combined with platinum doublet chemotherapy during perioperative period ; participants receive consolidation therapy of Toripalimab Intervention: Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","SBRT","SBRT. 24Gy\u002F3fractions Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg\u002Fm\\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg\u002Fm\\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg\u002Fm\\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg\u002Fm\\^2 by IV infusion Q3W",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Toripalimab","Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg\u002Fm\\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg\u002Fm\\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg\u002Fm\\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg\u002Fm\\^2 by IV infusion Q3W",[16,9],[33],"Toripalimab IV 240mg + platinum-based doublet chemotherapy",[35,39,42],{"name":36,"affiliation":37,"role":38},"Xuwei Cai","Department of Radiation Oncology， Shanghai Chest Hospital, Shanghai, China","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Zhigang Li","Department of Thoracic Surgery， Shanghai Chest Hospital, Shanghai, China",{"name":43,"affiliation":44,"role":38},"Songbing Qin","Department of Radiation Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China",[46],{"name":36,"role":47,"phone":48,"phoneExt":26,"email":49},"CONTACT","02122200000","birdhome2000@163.com",[51],{"facility":5,"status":52,"city":53,"state":26,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":26},"RECRUITING","Shanghai","China","CN",{"type":57,"coordinates":58},"Point",[59,60],121.45806,31.22222,{"lat":60,"lon":59},{"type":38,"investigatorFullName":36,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Director","100549741","phase-3-neoadjuvant-therapy-of-sbrt-sequencial-with-toripalimab-and-chemotherapy-in-resectable-stage-ii-iii-nsclc-patientsneor-torch-100549741",false,"NCT06437977","Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)","Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients: A Multicenter, Openlabel, Randomized, Phase III Trial","neoR-TORCH","Inclusion Criteria:\n\n1. Aged 18 -75 years, regardless of gender；\n2. ECOG score 0-1;\n3. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC ;\n4. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1;\n5. Tumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization ;\n6. According to the doctor's judgment, lung function can meet the requirements of pneumonectomy;\n7. Confirming the absence of EGFR\u002FALK sensitive gene mutations through molecular pathological diagnosis of the organization;\n8. Good organ function:\n\n   Bone marrow function: absolute neutrophil count ≥ 1.5 × 109\u002FL, platelet count ≥ 80 × 109\u002FL, hemoglobin ≥9 g\u002FdL; Liver function: total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 1.5 × ULN; Renal function: serum creatinine ≤ 1.5 × ULN or serum creatinine clearance rate ≥ 60 mL\u002Fmin; blood urea nitrogen ≤ 200mg\u002FL;\n9. Having sufficient understanding of this study and being willing to sign the informed consent form; 10. For female subjects of childbearing age, the serum pregnancy test should be negative within 3 days before receiving the first dose (cycle 1, day 1).\n\nExclusion Criteria:\n\n1. Have locally advanced unresectable or metastatic disease; unresectable includes unresectable stage III non-small cell lung cancer as defined by the Multidisciplinary Diagnosis and Treatment Consensus (2019 edition), including partial stages IIIA and IIIB and all stage IIIC, N2: single station mediastinal lymph nodes with short diameter≥3cm or N2: multi-station mediastinal metastasis with lymph node fusion and the short diameter of lymph node ≥2cm on CT, T4 invading esophagus, heart, aorta, pulmonary veins and all the N3;\n2. NSCLC involving superior sulcus, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumor;\n3. Participants with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous cell carcinoma;\n4. Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product;\n5. History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or ongoing pneumonitis\u002Finterstitial lung disease requiring steroid treatment;\n6. Active tuberculosis；\n7. Active infection requiring systemic treatment；\n8. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;\n9. Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen \\[HBsAg\\] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay \\\u003C500 IU\u002FmL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody \\[HCsAb\\] in screening period and positive HCV-RNA);\n10. Known human immunodeficiency virus (HIV) infection (known positive HIV antibody);\n11. Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella\u002F herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed);\n12. ≥ grade 2 peripheral neuropathy；\n13. Previous use of PD-1\u002FPD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40);\n14. Severe allergic reaction to other monoclonal antibodies;\n15. History of serious allergy to Pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or its preventive medications;\n16. Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months;\n17. History or current evidence of any disease, therapy or abnormal laboratory examination that may confuse the study results, interfere with subject's participation in the full course of the study or not meet the best interest of subject's participation in the study, as judged by investigators;\n18. Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival \\> 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded.","ALL","18 Years","75 Years",{"count":76,"type":77},478,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","This is a randomized, controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of SBRT sequencial with Toripalimab and chemotherapy versus Toripalimab and chemotherapy for subjects with resectable, stage II-III NSCLC.",[83],"Stage II-III Non-small Cell Lung Cancer","2026-05-08",{"date":86,"type":87},"2026-05-13","ACTUAL",{"date":89,"type":87},"2024-09-12",{"date":91,"type":77},"2029-06",{"name":5,"class":6},1]