[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620520":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":35,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Tori+D","EXPERIMENTAL","Diphenhydramine combined with Toripalimab plus standard platinum-based chemotherapy as perioperative treatment",[13,14,15],"Drug: Toripalimab (240mg day1, Q3W*3cycle)","Drug: Diphenhydramine","Drug: Platinum-based chemotherapy",{"label":17,"type":6,"description":18,"interventionNames":19},"Tori","Toripalimab plus standard platinum-based chemotherapy as perioperative treatment.",[13,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Toripalimab (240mg day1, Q3W*3cycle)","Toripalimab is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2). Toripalimab was administered concurrently with chemotherapy, Q3W",[17,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Diphenhydramine","Diphenhydramine, is an antihistamine. It has antihistamine H1 receptor effects, strong inhibitory effects on the central nervous system, and atropine-like effects. Diphenhydramine was administered 20mg qd IM d0-d2.",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Platinum-based chemotherapy","Carboplatin: AUC5 (per Calvert formula); maximum dose: 750 mg；Cisplatin: 75 mg\u002Fm² D1, Q3W; Pemetrexed: 500 mg\u002Fm² D1, Q3W; Docetaxel: 60-75 mg\u002Fm² or Paclitaxel: 175 mg\u002Fm², D1, Q3W",[17,9],[36],{"facility":37,"status":26,"city":38,"state":26,"zip":26,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","China","CN",{"type":42,"coordinates":43},"Point",[44,45],117.17667,39.14222,{"lat":45,"lon":44},[48,53,55],{"name":49,"role":50,"phone":51,"phoneExt":26,"email":52},"Shengguang Wang","CONTACT","86022-23340123-3220","wangshengguang@tjmuch.com",{"name":49,"role":54,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":56,"role":54,"phone":26,"phoneExt":26,"email":26},"Jie Xu",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100620520","phase-2-toripalimab-combined-with-platinum-based-chemotherapy-with-or-without-h1-receptor-antagonist-in-the-perioperative-treatment-of-resectable-non-small-cell-lung-cancer-100620520",false,"NCT07358689","Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer","Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist (Diphenhydramine) in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer: A Single-center, Randomized Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n* Voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits;\n* Aged 18-75 years, regardless of gender;\n* ECOG performance status score of 0-1;\n* Expected survival time ≥ 3 months;\n* \\- Pathologically\u002Fradiologically confirmed stage II-III NSCLC (AJCC 9th Edition). For adenocarcinoma\u002Fadenosquamous carcinoma, EGFR wild-type and ALK fusion-negative required before enrollment;\n* No prior systemic anti-tumor therapy;\n* At least one measurable lesion per RECIST 1.1. Previously irradiated lesions are measurable if progression is confirmed;\n* Adequate organ function, as evidenced by meeting the following laboratory parameters:\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL without administration of granulocyte colony-stimulating factor within the past 14 days;\n  2. Platelet count ≥ 80 × 10⁹\u002FL without blood transfusion within the past 14 days;\n  3. Hemoglobin \\> 8 g\u002FdL without blood transfusion or erythropoietin administration within the past 14 days;\n  4. Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN);\n  5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (for subjects with liver metastasis, AST or ALT ≤ 5 × ULN is acceptable);\n  6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin;\n  7. Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN;\n  8. Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free triiodothyronine \\[FT3\\]) and free thyroxine (FT4) within the normal range are also eligible for enrollment;\n  9. Myocardial enzyme profile within the normal range;\n* Females of childbearing potential: negative pregnancy test (urine\u002Fserum) within 3 days pre-first dose (Cycle 1 Day 1); serum test required if urine test unconfirmed. Non-childbearing females: postmenopausal ≥ 1 year, surgically sterile or hysterectomized;\n* Subjects at risk of conception: use contraception with annual failure rate \\\u003C 1% during treatment and 120-180 days post-last dose;\n\nExclusion Criteria:\n\n* Lung metastases from other primary malignancies;\n* Other systemic malignancies (excluding radically treated skin basal\u002Fsquamous cell carcinoma or resected carcinoma in situ);\n* Current or prior myasthenia gravis;\n* Current or prior angle-closure glaucoma;\n* Current or prior benign prostatic hyperplasia;\n* Diphenhydramine allergy;\n* Pyloroduodenal obstruction, peptic ulcer-induced pyloric stenosis or bladder neck stenosis;\n* Prior radiation therapy meeting any: 1) ≥ 30% bone marrow irradiated within 14 days pre-treatment; 2) Lung lesion radiation \\> 30 Gy within 6 weeks pre-treatment (must recover from radiation toxicity to Grade ≤ 1, no glucocorticoids, no radiation pneumonitis history);\n* Current participation in other interventional clinical studies, or received investigational agents\u002Fdevices within 4 weeks pre-first dose;\n* Systemic anti-lung cancer Chinese patent medicines or immunomodulators (thymosin, interferon, interleukin; excluding local pleural effusion control) within 2 weeks pre-first dose;\n* Active autoimmune diseases requiring systemic therapy (disease-modifying drugs, glucocorticoids, immunosuppressants) within 2 years pre-first dose (replacement therapy not considered systemic);\n* Ongoing systemic glucocorticoids (excluding topical) or immunosuppressants within 7 days pre-first dose (physiological doses: prednisone ≤ 10 mg\u002Fday or equivalent permitted);\n* Uncontrolled pleural\u002Fperitoneal effusion (eligible if no drainage needed or effusion stable 3 days post-drainage cessation);\n* Prior allogeneic organ transplantation (except corneal) or hematopoietic stem cell transplantation;\n* Inadequate recovery from prior intervention toxicities\u002Fcomplications (not resolved to Grade ≤ 1 or baseline, excluding fatigue\u002Falopecia);\n* Known HIV infection (HIV 1\u002F2 antibody positive);\n* Other conditions deemed unsuitable by investigator;","ALL","18 Years","75 Years",{"count":70,"type":71},120,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of H1 receptor antagonist (diphenhydramine) combined with toripalimab plus standard platinum-based chemotherapy in the perioperative setting in subjects with operable NSCLC.\n\nThe subjects of this study are patients with histologically or cytologically confirmed stage II-III NSCLC (AJCC Version 9) who are planned to receive neoadjuvant therapy with toripalimab combined with standard platinum-based chemotherapy. Eligible subjects were randomized at a 1:1 ratio to receive 3-4 cycles of neoadjuvant diphenhydramine (an H1 receptor antagonist) plus toripalimab and standard platinum-based chemotherapy, or toripalimab plus platinum-based chemotherapy alone, followed by treatment response evaluation and definitive surgery. After surgery, the experimental group will receive maintenance therapy with diphenhydramine (an H1 receptor antagonist) plus toripalimab for 13-14 cycles, while the control group will receive toripalimab monotherapy for the same 13-14 cycles.",[77],"NSCLC","NOT_YET_RECRUITING","2026-06-10",{"date":81,"type":82},"2026-06-12","ACTUAL",{"date":84,"type":71},"2026-06-30",{"date":86,"type":71},"2029-01-01",{"name":5,"class":6},1]