Идёт набор NCT06627647

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC

Фаза III С лечением Non-squamous 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: Rilvegostomig, Pembrolizumab, Carboplatin, Cisplatin.
Кому может быть актуально: Состояния в реестре: Non-squamous 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, Бельгия, Бразилия +20
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 III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

Обзор

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1.

Подробное описание

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1 (TC ≥ 1%).

Вмешательства

Препарат Rilvegostomig
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Препарат Pembrolizumab
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Препарат Carboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Препарат Cisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Препарат Pemetrexed
Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Первичные конечные точки

Overall survival (OS) [Срок оценки: Up to approximately 6 years]
Progression-free survival (PFS) [Срок оценки: Up to approximately 6 years]

Вторичные конечные точки (10)

Landmark overall survival (OS) rates [Срок оценки: Up to approximately 6 years]
Landmark progression-free survival (PFS) rates [Срок оценки: Up to approximately 6 years]
Time to second progression or death (PFS2) [Срок оценки: Up to approximately 6 years]
Overall response rate (ORR) [Срок оценки: Up to approximately 6 years]
Duration of response (DoR) [Срок оценки: Up to approximately 6 years]
Pharmacokinetic (PK) of rilvegostomig [Срок оценки: Up to approximately 6 years]
Immunogenicity of rilvegostomig [Срок оценки: Up to approximately 6 years]
Patient-reported physical functioning [Срок оценки: Up to approximately 6 years]
Patient-reported global health status (GHS)/quality of life (QoL) [Срок оценки: Up to approximately 6 years]
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) [Срок оценки: Up to approximately 6 years]

Критерии участия

Критерии включения

Histologically or cytologically documented non-squamous NSCLC.
Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved and available targeted 1L therapies.
Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
Adequate organ and bone marrow function

Критерии исключения

Presence of small cell and neuroendocrine histology components.
Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
Any prior systemic therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred > 12 months after the end of systemic therapy treatment.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
Active primary immunodeficiency/active infectious disease(s).
Active tuberculosis infection.

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: Четверное слепое
Основная цель: Лечение