[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612284":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":65,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":24,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Hunan Province Tumor Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Morning infusion group","EXPERIMENTAL","• Intervention \u002F treatment:\n\n* Immune checkpoint inhibitor (one of approved PD 1 agents per investigator choice; e.g., toripalimab \u002F pembrolizumab) administered in the morning window (08:00-11:00) for all ICI infusions during neoadjuvant treatment.\n* Combined with platinum based chemotherapy per institutional standard (examples: nab paclitaxel 260 mg\u002Fm² IV Day 1 Q3W + carboplatin AUC 5 IV Day 1 Q3W; or paclitaxel\u002Fcisplatin regimens per local practice).\n* Neoadjuvant treatment cycles: 4 cycles as per treating physician and local guideline; surgery scheduled after assessment.\n* Supportive care per routine practice.",[13],"Other: Time of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Afternoon infusion group","ACTIVE_COMPARATOR","• Intervention \u002F treatment:\n\n* Same systemic regimen as Arm 1, but all ICI infusions administered in the afternoon window (15:00-18:00).\n* Chemotherapy, number of cycles (4), and surgical decision follow the same rules as Arm 1.\n* Supportive care per routine practice.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Time of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy","Patients will be randomly assigned (1:1) to receive all ICI infusions during either the morning window (08:00-11:00) or the afternoon window (15:00-18:00), throughout the neoadjuvant treatment period.",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Yongchang Zhang, professor","CONTACT","+0086 13873123436","zhanglei1152@126.com",[32,57],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hunna Cancer Hospital, Clinical Trails Center","RECRUITING","Changsha","Hunan","410013","China","CN",{"type":41,"coordinates":42},"Point",[43,44],112.97087,28.19874,{"lat":44,"lon":43},[47,51,55],{"name":48,"role":28,"phone":49,"phoneExt":24,"email":50},"Yongchang Zhang, MD","+13873123436","zhangyongchang@csu.edu.cn",{"name":52,"role":28,"phone":53,"phoneExt":24,"email":54},"Liang Zeng, MD","+8673189762650","530490930@qq.com",{"name":48,"role":56,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":58,"status":34,"city":35,"state":36,"zip":24,"country":38,"countryCode":39,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Hunan Cancer hospital",{"type":41,"coordinates":60},[43,44],{"lat":44,"lon":43},[63],{"name":48,"role":28,"phone":64,"phoneExt":24,"email":50},"+86 13873123436",{"type":56,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Yongchang Zhang","DR","100612284","phase-3-effect-of-infusion-timing-on-pathologic-response-to-neoadjuvant-immunotherapy-in-resectable-non-small-cell-lung-cancer-100612284",false,"NCT07251582","Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer","A Prospective Study on the Effect of Infusion Timing of Immune Checkpoint Inhibitors on Pathologic Response in Patients With Resectable Stage II-III Non-Small Cell Lung Cancer Undergoing Neoadjuvant Therapy","LungTime-C02","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥18 and ≤75 years at the time of enrollment.\n2. Histologically or cytologically confirmed diagnosis of resectable stage II to III non-small cell lung cancer (NSCLC).\n3. Deemed suitable for neoadjuvant immunotherapy combined with platinum-based chemotherapy and subsequent surgical resection based on multidisciplinary team (MDT) assessment.\n4. ECOG Performance Status of 0 or 1.\n5. No prior systemic antitumor therapy for the current NSCLC diagnosis.\n6. Adequate bone marrow, hepatic, renal, and cardiac function based on local laboratory standards.\n7. Willing and able to comply with scheduled visits, treatment plans, and other study procedures.\n8. Signed informed consent prior to participation.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Presence of EGFR-sensitive mutations (e.g., exon 19del, L858R) or ALK\u002FROS1 rearrangements.\n2. Presence of uncontrolled or symptomatic brain metastases.\n3. History of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ.\n4. History of prior systemic therapy (immunotherapy, chemotherapy, or targeted therapy) for lung cancer.\n5. Known severe allergic reactions to PD-1 or PD-L1 inhibitors (Grade ≥3 by CTCAE).\n6. Active autoimmune disease requiring systemic immunosuppression.\n7. Active infections, including active HBV, HCV, or HIV infection.\n8. Pregnant or breastfeeding women.\n9. Any comorbid condition or uncontrolled illness that, in the opinion of the investigator, may interfere with study participation or pose unacceptable risk.","ALL","18 Years","75 Years",{"count":80,"type":81},156,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","This prospective study aims to investigate whether the time of day when immune checkpoint inhibitors (ICIs) are administered affects the efficacy of neoadjuvant immunotherapy in patients with resectable stage II-III non-small cell lung cancer (NSCLC). Eligible patients will receive standard-of-care neoadjuvant ICI plus platinum-based chemotherapy and be randomly assigned to either a morning infusion group (08:00-11:00) or an afternoon infusion group (15:00-18:00). The primary objective is to compare the pathological complete response (pCR) rates between groups. Secondary outcomes include major pathological response (MPR) and event-free survival (EFS). The study will include independent imaging and pathology review for endpoint assessment.",[87],"Resectable Stage II-III Non-Small Cell Lung Cancer (NSCLC)",[89,90,91],"NSCLC","Time of day","neoadjuvant treatment","2025-11-19",{"date":94,"type":95},"2025-11-26","ACTUAL",{"date":97,"type":81},"2025-12-07",{"date":99,"type":81},"2029-05-31",{"name":5,"class":6},2]