[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07630168":3,"trial-entities:NCT07630168":125,"trial-summary:NCT07630168":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":58,"secondary_outcomes":67,"sex":77,"minimum_age":78,"maximum_age":17,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":94,"locations":97,"central_contacts":116,"overall_officials":118,"references":120,"see_also_links":121},"NCT07630168","LCCC2526-DCT","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","NOT_YET_RECRUITING","2033-01-01","2026-07","2026-07-27","2026-08-01","UNC Lineberger Comprehensive Cancer Center","OTHER",true,"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.",null,[19,20,21,22,23,24,25],"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",[27,28],"programmed cell death protein 1","programmed death-ligand 1","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},238,"ESTIMATED",[37,43,48,53],{"type":38,"name":39,"description":40,"armGroupLabels":41},"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.",[42],"Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1\u002FPD-L1 start prior 12:00 PM",{"type":38,"name":44,"description":45,"armGroupLabels":46},"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.",[47],"Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1\u002FPD-L1 start after 3:00 PM",{"type":38,"name":49,"description":50,"armGroupLabels":51},"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.",[52],"Cohort 2A: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start prior 12:00 PM",{"type":38,"name":54,"description":55,"armGroupLabels":56},"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.",[57],"Cohort 2B: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start after 3:00 PM",[59,63],{"measure":60,"description":61,"timeFrame":62},"Progression free survival (PFS) - non-small cell lung cancer (NSCLC)","Progression free survival (PFS) will be measured as the time from the date of randomization to the earliest date of radiographic disease progression (PD), as determined by RECIST 1.1, or death from any cause in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).","Up to 2 years",{"measure":64,"description":65,"timeFrame":66},"Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC).","Major Pathologic Response (MPR) is defined as participant with ≤10% viable tumor in resected tumor tissue in patients with resectable head and neck squamous cell carcinoma (HNSCC).","Up to 3 months",[68,71,74],{"measure":69,"description":70,"timeFrame":62},"Overall survival (OS) - non-small cell lung cancer (NSCLC)","Overall survival (OS) is defined as the time from randomization to death from any cause in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).",{"measure":72,"description":73,"timeFrame":62},"Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC)","Objective Response Rate defined as the proportion of patients achieving a Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 To determine if time of day of immune checkpoint inhibitor administration impacts treatment response in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).",{"measure":75,"description":76,"timeFrame":66},"Timing of surgery","Timing of surgery is defined as the time from the last neoadjuvant dose to the date of surgery.","ALL","18 Years",false,{"inclusion":81,"exclusion":89,"raw_text":93},[82,83,84,85,86,83,87,88,85],"Participants with metastatic non-small cell lung cancer (NSCLC).","Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.","Subject is willing and able to comply with study procedures based on the judgement of the investigator.","Age ≥ 18 years at the time of consent.","Participants with resectable head and neck squamous cell carcinoma (HNSCC)","Subject is willing and able to comply with study procedures based on the judgement","of the investigator.",[90,91,92],"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.","Prior immune checkpoint inhibitors (ICI) such as programmed cell death protein 1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor or Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) treatment received less than 6 months from the time of screening.","Subject is participating in another treatment clinical trial.","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 immune checkpoint inhibitors (ICI) such as programmed cell death protein 1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor or Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) treatment received less than 6 months from the time of screening.\n* Subject is participating in another treatment clinical trial.",[95,96],"ADULT","OLDER_ADULT",[98],{"facility":99,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":113},"University of North Carolina at Chapel Hill, Department of Radiation Oncology","Chapel Hill","North Carolina","27599","United States",[105,110],{"name":106,"role":107,"phone":108,"email":109},"Adrianna Warner","CONTACT","919-984-0000","Adrianna_warner@med.unc.edu",{"name":111,"role":112},"Shetal A Patel, MD","PRINCIPAL_INVESTIGATOR",{"lat":114,"lon":115},35.9132,-79.05584,[117],{"name":106,"role":107,"phone":108,"email":109},[119],{"name":111,"affiliation":13,"role":112},[],[122],{"label":123,"url":124},"University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials","http:\u002F\u002Funclineberger.org\u002Fpatientcare\u002Fclinical-trials\u002Fclinical-trials",{"nct_id":4,"conditions":126,"biomarkers":129},[127,128],"Head and Neck Squamous Cell Carcinoma","Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":131,"prompt_version":141},{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 238 participants and will randomly assign them to receive immunotherapy in the morning or afternoon.","completed","Immunotherapy Timing for Lung and Head & Neck Cancers","This study is looking at whether the time of day you receive immunotherapy affects how well it works for certain cancers. It's for people with advanced non-small cell lung cancer (NSCLC) or head and neck squamous cell carcinoma (HNSCC). You would receive either a PD-1 or PD-L1 inhibitor (types of immunotherapy) either before noon or after 3 PM for 2 or 4 cycles. Researchers want to see if giving these treatments at different times of day changes how long people live without their cancer getting worse (progression-free survival) or how much the tumor shrinks. The study plans to enroll 238 participants, and it's currently unclear if they are actively recruiting.","For non-small cell lung cancer, researchers will track progression-free survival for up to 2 years. For head and neck squamous cell carcinoma, they will measure major pathologic response for up to 3 months.",110,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]