Clinical trial · Interventional
Effects of Infusion Timing on Treatment Response in Solid Tumors
Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Squamous Cell Carcinoma | Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Resectable Head and Neck Squamous-cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor monotherapy - 2 cycles after 3 PM | Drug | — | UNRESOLVED |
| PD-1 inhibitor monotherapy - 2 cycles before 12:00PM | Drug | — | UNRESOLVED |
| PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM | Drug | — | UNRESOLVED |
| PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start prior 12:00 PM
- 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.
- interventionNames
- Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM
- type
- EXPERIMENTAL
- label
- Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start after 3:00 PM
- 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.
- interventionNames
- Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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