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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A: NSCLC received Anti- PD-1/PD-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. |
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| Cohort 1B: NSCLC received Anti- PD-1/PD-L1 start after 3:00 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 after 3:00 PM. |
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| Cohort 2A: HNSCC received Anti- PD-1 start prior 12:00 PM | Experimental | 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. |
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| Cohort 2B: HNSCC received Anti- PD-1 start after 3:00 PM | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 2 years |
| Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC) |
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Inclusion Criteria:
Cohort 1A and 1B:
Cohort 2A and 2B:
Exclusion Criteria: For All Cohorts (1A,1B, 2A, 2B)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrianna Warner | Contact | 919-984-0000 | Adrianna_warner@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shetal A Patel, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill, Department of Radiation Oncology | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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| PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM | Drug | 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. |
|
| PD-1 inhibitor monotherapy - 2 cycles before 12:00PM | Drug | PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered before 12:00PM for 2 cycles. |
|
| PD-1 inhibitor monotherapy - 2 cycles after 3 PM | Drug | PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles. |
|
Objective Response Rate defined as the proportion of patients achieving a Complete Response (CR) or Partial Response (PR) as determined by 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). |
| Up to 2 years |
| Timing of surgery | Timing of surgery is defined as the time from the last neoadjuvant dose to the date of surgery. | Up to 3 months |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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