Effects of Infusion Timing on Treatment Response in Solid Tumors (TIMED)
2026年9月14日 更新者：UNC Lineberger Comprehensive Cancer Center
Timing of Immunotherapy and Effective Administration (TIMED): 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.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
238
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Adrianna Warner
- 电话号码：919-984-0000
- 邮箱：Adrianna_warner@med.unc.edu
学习地点
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599
- 招聘中
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
-
接触：
- Adrianna Warner
- 电话号码：919-984-0000
- 邮箱：Adrianna_warner@med.unc.edu
-
首席研究员：
- Shetal A Patel, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start prior 12:00 PM
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.
|
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.
|
|
实验性的：Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start after 3:00 PM
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.
|
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.
|
|
实验性的：Cohort 2A: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start prior 12:00 PM
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.
|
PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered before 12:00PM for 2 cycles.
|
|
实验性的：Cohort 2B: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start after 3:00 PM
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.
|
PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression free survival (PFS) - non-small cell lung cancer (NSCLC)
大体时间：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).
|
Up to 2 years
|
|
Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC).
大体时间：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).
|
Up to 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival (OS) - non-small cell lung cancer (NSCLC)
大体时间：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).
|
Up to 2 years
|
|
Timing of surgery
大体时间：Up to 3 months
|
Timing of surgery is defined as the time from the last neoadjuvant dose to the date of surgery.
|
Up to 3 months
|
|
Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC)
大体时间：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).
|
Up to 2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Shetal A Patel, MD、UNC Lineberger Comprehensive Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月3日
初级完成 (估计的)
2033年1月1日
研究完成 (估计的)
2033年1月1日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年9月15日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.