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NCT Number: NCT07630168

Effects of Infusion Timing on Treatment Response in Solid Tumors

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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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Head and Neck Cancer Head and Neck Neoplasms Lung Diseases Lung Neoplasms Metastatic Head and Neck Cancer Metastatic Lung Cancer Metastatic Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Non-small Cell Lung Cancer Resectable Head and Neck Squamous-cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

Location contact

Adrianna Warner

CONTACT

[email protected]

919-984-0000

Shetal A Patel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Progression free survival (PFS) - non-small cell lung cancer (NSCLC)

    Time frame: Up to 2 years

    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).

  2. Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC).

    Time frame: Up to 3 months

    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).

Secondary outcomes

  1. Overall survival (OS) - non-small cell lung cancer (NSCLC)

    Time frame: Up to 2 years

    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).

  2. Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC)

    Time frame: Up to 2 years

    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).

  3. Timing of surgery

    Time frame: Up to 3 months

    Timing of surgery is defined as the time from the last neoadjuvant dose to the date of surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Adrianna Warner

CONTACT

[email protected]

919-984-0000

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors

Acronym: TIMED

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Jun 5, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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