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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 15, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07630168). This is a study registration, not published results. Lead sponsor: UNC Lineberger Comprehensive Cancer Center. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 238 participants (ESTIMATED). Conditions: 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. Interventions: DRUG: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM; DRUG: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM; DRUG: PD-1 inhibitor monotherapy - 2 cycles before 12:00PM; DRUG: PD-1 inhibitor monotherapy - 2 cycles after 3 PM. Primary outcome measures: Progression free survival (PFS) - non-small cell lung cancer (NSCLC) , Up to 2 years; Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC). , Up to 3 months. Brief summary: 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.