Идёт набор NCT06561386

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

Фаза III С лечением Non-small Cell Lung 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: Nivolumab, Relatlimab, Pembrolizumab, Carboplatin.
Кому может быть актуально: Состояния в реестре: Non-small Cell Lung 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, Аргентина, Австралия, Австрия, Бельгия +26
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

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

Обзор

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%

Вмешательства

Препарат Nivolumab
Specified dose on specified days
Препарат Relatlimab
Specified dose on specified days
Препарат Pembrolizumab
Specified dose on specified days
Препарат Carboplatin
Specified dose on specified days
Препарат Pemetrexed
Specified dose on specified days
Препарат Cisplatin
Specified dose on specified days

Первичные конечные точки

Overall survival (OS) in randomized participants with PD-L1 1% to 49% [Срок оценки: Up to 5 years]

Вторичные конечные точки (8)

OS in randomized participants with PD-L1 ≥ 1% [Срок оценки: Up to 5 years]
Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR) [Срок оценки: Up to 5 years]
Overall response rate (ORR) [Срок оценки: Up to 5 years]
Duration of response (DoR) [Срок оценки: Up to 5 years]
Number of participants with adverse events (AEs) [Срок оценки: Up to 2.5 years]
Number of participants with serious adverse events (SAEs) [Срок оценки: Up to 2.5 years]
Number of participants with immune-mediated adverse events (IMAEs) [Срок оценки: Up to 2.5 years]
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
Participants must have a life expectancy of at least 3 months at the time of randomization.

Критерии исключения

Participants must not be pregnant and/or breastfeeding.
Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
Participants must not have untreated central nervous system (CNS) metastases.
Participants must not have leptomeningeal metastases (carcinomatous meningitis).
Participants must not have concurrent malignancy requiring treatment.
Participants must not have an active autoimmune disease.
Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.
Participants must not have a history of myocarditis.
Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
Other protocol-defined Inclusion/Exclusion criteria apply.

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