Effects of Infusion Timing on Treatment Response in Solid Tumors (TIMED)

UNC Lineberger Comprehensive Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Squamous Cell Carcinoma; Metastatic Head and Neck Cancer; Non-small Cell Lung Cancer; Lung Cancer; Resectable Head and Neck Squamous-cell Carcinoma; Head and Neck Cancer; Metastatic Lung Cancer

Treatments: 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/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM; Drug: PD-1 inhibitor monotherapy - 2 cycles after 3 PM

Study type: Interventional

Funder types: Other

Identifiers

NCT07630168

LCCC2526-DCT

Details and patient eligibility

About

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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Cohort 1A and 1B:

• 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.

Cohort 2A and 2B:

• Participants with resectable head and neck squamous cell carcinoma (HNSCC)
• 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.

Exclusion Criteria: For All Cohorts (1A,1B, 2A, 2B)

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 4 patient groups

Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start prior 12:00 PM

Experimental group

Description:

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.

Treatment:

Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM

Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start after 3:00 PM

Experimental group

Description:

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.

Treatment:

Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM

Cohort 2A: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start prior 12:00 PM

Experimental group

Description:

Patients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment before 12:00 PM.

Treatment:

Drug: PD-1 inhibitor monotherapy - 2 cycles before 12:00PM

Cohort 2B: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start after 3:00 PM

Experimental group

Description:

Patients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC)eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment after 3:00 PM.

Treatment:

Drug: PD-1 inhibitor monotherapy - 2 cycles after 3 PM