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Набор скоро начнётся NCT07630168

Effects of Infusion Timing on Treatment Response in Solid Tumors

Фаза II С лечением Lung Cancer Non-small Cell Lung Cancer Metastatic Lung Cancer Head and Neck Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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.
Кому может быть актуально
Состояния в реестре: Lung Cancer, Non-small Cell Lung Cancer, Metastatic Lung Cancer, Head and Neck Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат 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.
  • Препарат 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.
  • Препарат 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.
  • Препарат 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill

Идентификаторы

NCT: NCT07630168 · LCCC2526-DCT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗