Идёт набор NCT07224971

Impact of Circadian Rhythm on Immunotherapy

Фаза II С лечением Advanced/Metastatic NSCLC

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: Immunotherapy - PD-1 Blocker.
Кому может быть актуально: Состояния в реестре: Advanced/Metastatic NSCLC. 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Assessing the Impact of Circadian Rhythm on Anti-PD-1/PD-L1 Immunotherapy

Обзор

This study aims to determine whether morning versus afternoon treatment impacts efficacy of (standard of care) immunotherapy in a broad patient population. Patients with any type of advanced/metastatic malignancy are eligible to enroll in this study, as long as first-line anti-PD-1/PD-L1 immunotherapy is on label for their condition. Participants will then be randomized to either the early treatment group (administration must start and conclude by 11:00 AM +1 hour window) or the late treatment group (administration must start after 12:00 PM).

Подробное описание

The US market has many FDA approved options for anti-PD-1/PD-L1 immunotherapies, including pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, among others that are in development. With an estimated 56.55% of cancer patients eligible for treatment with anti-PD-1/PD-L1 immunotherapy (as of 2023), the impact of timing on immunotherapy efficacy should be delineated in order to provide the best care possible to patients This study will be implemented at a large regional cancer center in the United States. Three patient cohorts will be investigated: Non-Small Cell Lung Cancer (NSCLC) patients who receive first-line ICI therapy (Cohort A), NSCLC patients with stable disease or response after induction therapy receiving maintenance ICI therapy (Cohort B), and solid tumor patients receiving first-line ICI therapy (Cohort C).

To the best the knowledge of this principal investigator, this is the first prospective time-of-day immunotherapy study to take place in the US. Key endpoints include real-world progression free survival (rwPFS)\[26\], overall survival (OS), safety, quality of life (QoL), and pharmacoeconomic outcomes.

Вмешательства

Препарат Immunotherapy - PD-1 Blocker
Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune checkpoint inhibitors used in cancer treatment that targets cancer cells by blocking the PD-1 receptor on T cells.

Первичные конечные точки

Real-world progression-free survival (rwPFS) - Cohort A [Срок оценки: Up to 4.5 years]

Вторичные конечные точки (11)

Overall Survival (OS) - Cohort A [Срок оценки: Up to 4.5 years]
Real-world progression-free survival (rwPFS) - Cohort B [Срок оценки: Up to 4.5 years]
Real-world progression-free survival (rwPFS) - Cohort C [Срок оценки: Up to 4.5 years]
Overall Survival (OS) - Cohort B [Срок оценки: Up to 4.5 years]
Overall Survival (OS) - Cohort C [Срок оценки: Up to 4.5 years]
Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort A [Срок оценки: At Screening - Up to 28 days after signed consent]]
Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort B [Срок оценки: At Screening - Up to 28 days after signed consent]]
Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort C [Срок оценки: At Screening - Up to 28 days after signed consent]]
Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort A [Срок оценки: At Day 1 of Each Treatment Cycle (2-6-week cycles, per specific agent)]
Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort B [Срок оценки: At Day 1 of Each Treatment Cycle (2-6-week cycles, per specific agent)]
Health Related Quality of Life (HRQoL) - EQ-5D-5L - Cohort C [Срок оценки: At Day 1 of Each Treatment Cycle (2-6-week cycles, per specific agent)]

Критерии участия

Критерии включения

Cohort Specific Criteria

Cohort A: Advanced/metastatic NSCLC patients for which 1st line PD-1/PD-L1 therapy is on-label either alone or in combination.
Cohort B: Advanced/metastatic NSCLC patients who have completed up to 4 cycles of induction therapy who have stable disease or responsive disease and for which maintenance anti-PD-1/PD-L1 therapy is on-label either alone or in combination.
Cohort C: Advanced/metastatic solid tumor malignancy for which first-line anti-PD-1/PD-L1 therapy is on-label either alone or in combination.
Prior and concurrent therapy criteria

o Patients should be ICI-naïve (this should be first-line therapy) (Cohorts A and C), or should have received ICI induction therapy and are now eligible for ICI maintenance therapy (Cohort B).

Must be willing to be randomized to complete therapy at assigned time of day, which may be early in the morning OR later in the day/into the evening.
Must be eligible to receive anti-PD-1/PD-L1 therapy singly or in combination with other FDA-approved agents according to standard of care practices, as determined by the clinical judgment of the investigator but according to approved label indications
Must have the ability to understand and the willingness to sign a written informed consent document.
Able to read and write in English.