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Not yet recruiting NCT07630168

Effects of Infusion Timing on Treatment Response in Solid Tumors

Phase II Interventional Lung Cancer Non-small Cell Lung Cancer Metastatic Lung Cancer Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM, PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM, PD-1 inhibitor monotherapy - 2 cycles before 12:00PM, PD-1 inhibitor monotherapy - 2 cycles after 3 PM.
Who it may be relevant to
Registry conditions: Lung Cancer, Non-small Cell Lung Cancer, Metastatic Lung Cancer, Head and Neck Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM
    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.
  • Drug PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM
    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.
  • Drug PD-1 inhibitor monotherapy - 2 cycles before 12:00PM
    PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered before 12:00PM for 2 cycles.
  • Drug PD-1 inhibitor monotherapy - 2 cycles after 3 PM
    PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles.

Primary outcome measures

  • Progression free survival (PFS) - non-small cell lung cancer (NSCLC) [Time frame: Up to 2 years]
  • Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC). [Time frame: Up to 3 months]
Secondary outcome measures (3)
  • Overall survival (OS) - non-small cell lung cancer (NSCLC) [Time frame: Up to 2 years]
  • Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC) [Time frame: Up to 2 years]
  • Timing of surgery [Time frame: Up to 3 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill

Identifiers

NCT: NCT07630168 · LCCC2526-DCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗