[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07224971":3,"trial-entities:NCT07224971":106,"trial-summary:NCT07224971":111},{"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":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":43,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":79,"locations":82,"central_contacts":100,"overall_officials":102,"references":104,"see_also_links":105},"NCT07224971","HCC 25-127","Impact of Circadian Rhythm on Immunotherapy","Assessing the Impact of Circadian Rhythm on Anti-PD-1\u002FPD-L1 Immunotherapy","RECRUITING","2030-05-01","2025-12","2025-12-09","2025-12-02","Liza Villaruz, MD","OTHER",true,"This study aims to determine whether morning versus afternoon treatment impacts efficacy of (standard of care) immunotherapy in a broad patient population. Patients with any type of advanced\u002Fmetastatic malignancy are eligible to enroll in this study, as long as first-line anti-PD-1\u002FPD-L1 immunotherapy is on label for their condition. Participants will then be randomized to either the early treatment group (administration must start and conclude by 11:00 AM +1 hour window) or the late treatment group (administration must start after 12:00 PM).","The US market has many FDA approved options for anti-PD-1\u002FPD-L1 immunotherapies, including pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, among others that are in development. With an estimated 56.55% of cancer patients eligible for treatment with anti-PD-1\u002FPD-L1 immunotherapy (as of 2023), the impact of timing on immunotherapy efficacy should be delineated in order to provide the best care possible to patients This study will be implemented at a large regional cancer center in the United States. Three patient cohorts will be investigated: Non-Small Cell Lung Cancer (NSCLC) patients who receive first-line ICI therapy (Cohort A), NSCLC patients with stable disease or response after induction therapy receiving maintenance ICI therapy (Cohort B), and solid tumor patients receiving first-line ICI therapy (Cohort C).\n\nTo the best the knowledge of this principal investigator, this is the first prospective time-of-day immunotherapy study to take place in the US. Key endpoints include real-world progression free survival (rwPFS)\\[26\\], overall survival (OS), safety, quality of life (QoL), and pharmacoeconomic outcomes.",[19],"Advanced\u002FMetastatic NSCLC",[21,22],"anti-PD-1\u002FPD-L1 Immunotherapy","Circadian Rhythm","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},350,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Immunotherapy - PD-1 Blocker","Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune checkpoint inhibitors used in cancer treatment that targets cancer cells by blocking the PD-1 receptor on T cells.",[36,37],"Early Immunotherapy dosing","Late Immunotherapy dosing",[39],{"measure":40,"description":41,"timeFrame":42},"Real-world progression-free survival (rwPFS) - Cohort A","Time from first dose of 1st line treatment to clinician documented clinical disease progression, initiation of new line of therapy, or death from any cause, whichever comes first. Real-world progression-free survival (rwPFS), defined as the time from first dose of 1st line treatment to clinician documented clinical disease progression, initiation of new line of therapy, or death from any cause, whichever came first. Per RECISIT v1.1, Progressive Disease: ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.","Up to 4.5 years",[44,47,50,52,54,56,60,62,64,66,67],{"measure":45,"description":46,"timeFrame":42},"Overall Survival (OS) - Cohort A","Overall Survival (OS) defined as time from first dose of 1st line treatment to death from any cause.",{"measure":48,"description":49,"timeFrame":42},"Real-world progression-free survival (rwPFS) - Cohort B","Time from first dose of 1st line treatment to clinician documented clinical disease progression, initiation of new line of therapy, or death from any cause, whichever came first. Per RECISIT v1.1, Progressive Disease: ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.",{"measure":51,"description":49,"timeFrame":42},"Real-world progression-free survival (rwPFS) - Cohort C",{"measure":53,"description":46,"timeFrame":42},"Overall Survival (OS) - Cohort B",{"measure":55,"description":46,"timeFrame":42},"Overall Survival (OS) - Cohort C",{"measure":57,"description":58,"timeFrame":59},"Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort A","Patient reported HRQoL scores using the EQ-5D-5L instrument. EQ-5D-5L is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Scores from each of the five dimensions range from 1 to 5. Total score ranges from 5 to 25, where higher scores indicate worse health status.","At Screening - Up to 28 days after signed consent]",{"measure":61,"description":58,"timeFrame":59},"Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort B",{"measure":63,"description":58,"timeFrame":59},"Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort C",{"measure":57,"description":58,"timeFrame":65},"At Day 1 of Each Treatment Cycle (2-6-week cycles, per specific agent)",{"measure":61,"description":58,"timeFrame":65},{"measure":63,"description":58,"timeFrame":65},"ALL","18 Years",null,false,{"inclusion":73,"exclusion":77,"raw_text":78},[74,75,76],"Cohort A: Advanced\u002Fmetastatic NSCLC patients for which 1st line PD-1\u002FPD-L1 therapy is on-label either alone or in combination.","Cohort B: Advanced\u002Fmetastatic NSCLC patients who have completed up to 4 cycles of induction therapy who have stable disease or responsive disease and for which maintenance anti-PD-1\u002FPD-L1 therapy is on-label either alone or in combination.","Cohort C: Advanced\u002Fmetastatic solid tumor malignancy for which first-line anti-PD-1\u002FPD-L1 therapy is on-label either alone or in combination. 2. Prior and concurrent therapy criteria",[],"Inclusion Criteria:\n\n1. Cohort Specific Criteria\n\n   * Cohort A: Advanced\u002Fmetastatic NSCLC patients for which 1st line PD-1\u002FPD-L1 therapy is on-label either alone or in combination.\n   * Cohort B: Advanced\u002Fmetastatic NSCLC patients who have completed up to 4 cycles of induction therapy who have stable disease or responsive disease and for which maintenance anti-PD-1\u002FPD-L1 therapy is on-label either alone or in combination.\n   * Cohort C: Advanced\u002Fmetastatic solid tumor malignancy for which first-line anti-PD-1\u002FPD-L1 therapy is on-label either alone or in combination.\n2. Prior and concurrent therapy criteria\n\n   o Patients should be ICI-naïve (this should be first-line therapy) (Cohorts A and C), or should have received ICI induction therapy and are now eligible for ICI maintenance therapy (Cohort B).\n3. Must be willing to be randomized to complete therapy at assigned time of day, which may be early in the morning OR later in the day\u002Finto the evening.\n4. Must be eligible to receive anti-PD-1\u002FPD-L1 therapy singly or in combination with other FDA-approved agents according to standard of care practices, as determined by the clinical judgment of the investigator but according to approved label indications\n5. Must have the ability to understand and the willingness to sign a written informed consent document.\n6. Able to read and write in English.\n\nExclusion Criteria:\n\n1\\. Participant unable to receive anti-PD-1\u002FPD-L1 therapy due to prior allergic reactions to therapy or any therapy ingredients.",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":97},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Jennifer Ruth, RN","CONTACT","412-623-8963","ruthj2@upmc.edu",{"name":13,"role":96},"PRINCIPAL_INVESTIGATOR",{"lat":98,"lon":99},40.44062,-79.99589,[101],{"name":91,"role":92,"phone":93,"email":94},[103],{"name":13,"affiliation":84,"role":96},[],[],{"nct_id":4,"conditions":107,"biomarkers":110},[108,109],"Lung Non-Small Cell Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study where participants will be randomly assigned to receive their immunotherapy either in the early morning or in the afternoon.","completed","Impact of Circadian Rhythm on Immunotherapy for Advanced NSCLC","This study is looking at whether the time of day you receive standard immunotherapy for advanced non-small cell lung cancer (NSCLC) affects how well it works. Researchers want to see if getting your treatment in the morning versus the afternoon makes a difference. The immunotherapy drugs being studied are common ones like pembrolizumab, nivolumab, and others that block the PD-1 receptor on T cells to fight cancer. You could be eligible if you have advanced\u002Fmetastatic NSCLC and are starting first-line immunotherapy, or if you've had some initial immunotherapy and are continuing with maintenance treatment. The main goal is to see how long patients live without their cancer getting worse (real-world progression-free survival). The study is currently unclear on its recruitment status and plans to enroll 350 participants.","The primary endpoint, real-world progression-free survival, will be measured for up to 4.5 years.",127,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]