[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639751":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":52,"locations":58,"responsibleParty":75,"collaborators":35,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":35,"enrollmentInfo":87,"targetDuration":35,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":102,"overallStatus":105,"whyStopped":35,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1A: NSCLC received Anti- PD-1\u002FPD-L1 start prior 12:00 PM","EXPERIMENTAL","Patients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment before 12:00 PM.",[13],"Drug: PD-1\u002FPD-L1 inhibitor monotherapy - 4 cycles before 12:00PM",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 1B: NSCLC received Anti- PD-1\u002FPD-L1 start after 3:00 PM","Patients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment after 3:00 PM.",[18],"Drug: PD-1\u002FPD-L1 inhibitor monotherapy - 4 cycles after 3 PM",{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 2A: HNSCC received Anti- PD-1 start prior 12:00 PM","Patients with advanced or metastatic locally advanced, resectable HNSCC eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment before 12:00 PM.",[23],"Drug: PD-1 inhibitor monotherapy - 2 cycles before 12:00PM",{"label":25,"type":10,"description":26,"interventionNames":27},"Cohort 2B: HNSCC received Anti- PD-1 start after 3:00 PM","Patients with advanced or metastatic locally advanced, resectable HNSCC eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment after 3:00 PM.",[28],"Drug: PD-1 inhibitor monotherapy - 2 cycles after 3 PM",[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","PD-1\u002FPD-L1 inhibitor monotherapy - 4 cycles before 12:00PM","PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered before 12:00PM for 4 cycles.",[9],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"PD-1\u002FPD-L1 inhibitor monotherapy - 4 cycles after 3 PM","PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered after 3 PM for 4 cycles.",[15],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"PD-1 inhibitor monotherapy - 2 cycles before 12:00PM","PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered before 12:00PM for 2 cycles.",[20],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"PD-1 inhibitor monotherapy - 2 cycles after 3 PM","PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles.",[25],[49],{"name":50,"affiliation":5,"role":51},"Shetal A Patel, MD","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":35,"email":57},"Adrianna Warner","CONTACT","919-984-0000","Adrianna_warner@med.unc.edu",[59],{"facility":60,"status":35,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"University of North Carolina at Chapel Hill, Department of Radiation Oncology","Chapel Hill","North Carolina","27599","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-79.05584,35.9132,{"lat":70,"lon":69},[73,74],{"name":54,"role":55,"phone":56,"phoneExt":35,"email":57},{"name":50,"role":51,"phone":35,"phoneExt":35,"email":35},{"type":76,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100639751","phase-2-effects-of-infusion-timing-on-treatment-response-in-solid-tumors-100639751",false,"NCT07630168","Effects of Infusion Timing on Treatment Response in Solid Tumors","Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors","TIMED","Inclusion Criteria:\n\nCohort 1A and 1B:\n\n* Participants with metastatic non-small cell lung cancer (NSCLC).\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nCohort 2A and 2B:\n\n* Participants with resectable head and neck squamous cell carcinoma (HNSCC)\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement\n* of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nExclusion Criteria: For All Cohorts (1A,1B, 2A, 2B)\n\n* Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.\n* Prior ICI (PD-1\u002FPD-L1\u002FCTLA4) treatment received less than 6 months from the time of screening.\n* Subject is participating in another treatment clinical trial.","ALL","18 Years",{"count":88,"type":89},238,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.",[95,96,97,98,99,100,101],"Lung Cancer","Non-small Cell Lung Cancer","Metastatic Lung Cancer","Head and Neck Cancer","Metastatic Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Resectable Head and Neck Squamous-cell Carcinoma",[103,104],"programmed cell death protein 1","programmed death-ligand 1","NOT_YET_RECRUITING","2026-06-01",{"date":108,"type":109},"2026-06-05","ACTUAL",{"date":106,"type":89},{"date":112,"type":89},"2033-01-01",{"name":5,"class":6},1]