- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07802821
A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Контакты исследования
- Имя: Haiying Yu, Bachelor
- Номер телефона: +86-17821799566
- Электронная почта: haiying.yu@qilu-pharma.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age ≥18 years.
- Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system.
- No prior systemic treatment for ES-SCLC.
- At least one extracranial measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment.
- Life expectancy ≥12 weeks.
- Has adequate organ function.
- Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy.
- Voluntarily sign the written informed consent form and comply with the protocol requirements.
Exclusion Criteria:
Has received or undergoing any of the following treatment:
Previous or current treatment with B7-H3 targeted therapy. Previous or current treatment with topoisomerase I inhibitors.
- Participants with transformed Non-Small Cell Lung Cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation-positive NSCLC that has transformed to SCLC, or mixed SCLC-NSCLC histology.
- Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression.
- Radiotherapy with a limited field of radiation within 2 weeks prior to the study treatment; more than 30% of the bone marrow irradiation or large-scale radiotherapy within 4 weeks prior to study treatment.
- Major surgery within 4 weeks prior to the study treatment.
- Unresolved AEs ≥ Grade 2 (CTCAE v6.0) from prior therapy.
- Previous or concurrent primary malignancies.
- History of severe heart disease or cerebrovascular disease.
- History of Severe or uncontrolled hypertension or diabetes mellitus.
- Severe infection within 4 weeks prior to study treatment; or uncontrolled active infection at screening.
- Known or suspected interstitial lung disease/non-infectious pneumonitis; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.
- Known history of pre-existing or newly diagnosed autoimmune disease.
- History of severe neuropathy or mental disorders.
- History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to study drugs or any components of the study drugs.
- Unlikely to comply with study procedures and requirements in the opinion of the investigator.
- Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: QLC5508 in combination with QL2107
|
QLC5508 will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
QL2107 will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity.
The maximum treatment duration for QL2107 will be 2 years.
|
|
Активный компаратор: Tislelizumab in Combination with Platinum-based Chemotherapy
|
Tislelizumab will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity.
The maximum treatment duration for Tislelizumab will be 2 years.
Carboplatin will be administered intravenously once every 3 weeks.
Carboplatin treatment will be administered for up to 4 cycles.
Cisplatin will be administered intravenously once every 3 weeks.
Cisplatin treatment will be administered for up to 4 cycles.
Etoposide will be administered intravenously once every 3 weeks.
Etoposide treatment will be administered for up to 4 cycles.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall survival (OS)
Временное ограничение: Up to approximately 36 months
|
OS is defined as the duration from the date of randomization to the date of death due to any cause.
|
Up to approximately 36 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Progression-free survival (PFS)
Временное ограничение: Up to approximately 36 months
|
PFS is defined as the duration from the date of randomization to the date of first documented progressive disease (PD) based on investigator assessment, or death from any cause, whichever occurs first.
|
Up to approximately 36 months
|
|
Objective response rate (ORR)
Временное ограничение: Up to approximately 36 months
|
ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
|
Up to approximately 36 months
|
|
Duration of response (DOR)
Временное ограничение: Up to approximately 36 months
|
DOR is defined as the duration from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
|
Up to approximately 36 months
|
|
Disease control rate (DCR)
Временное ограничение: Up to approximately 36 months
|
DCR is defined as the percentage of participants achieved complete response, partial response, or stable disease as assessed according to RECIST v1.1 criteria.
|
Up to approximately 36 months
|
|
6-month PFS rate
Временное ограничение: Up to approximately 36 months
|
The 6-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 6 months from the date of randomization.
|
Up to approximately 36 months
|
|
12-month PFS rate
Временное ограничение: Up to approximately 36 months
|
The 12-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 12 months from the date of randomization.
|
Up to approximately 36 months
|
|
12-month OS rate
Временное ограничение: Up to approximately 36 months
|
The 12-month OS rate is defined as the proportion of participants who are alive at 12 months from the date of randomization.
|
Up to approximately 36 months
|
|
24-month OS rate
Временное ограничение: Up to approximately 36 months
|
The 24-month OS rate is defined as the proportion of participants who are alive at 24 months from the date of randomization.
|
Up to approximately 36 months
|
|
Treatment Emergent Adverse Event (TEAE)
Временное ограничение: Up to approximately 36 months
|
TEAEs are defined as any adverse event (AE) that occurs after the initiation of study treatment, or any pre-existing condition that worsens in severity or frequency after the initiation of study treatment, regardless of the causal relationship to the study treatment. TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0. |
Up to approximately 36 months
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Легочные заболевания
- Новообразования дыхательных путей
- Грудные новообразования
- Новообразования легких
- Рак, Бронхогенный
- Бронхиальные новообразования
- Мелкоклеточная карцинома легкого
- Органические химические вещества
- Углеводороды
- Углеводороды, циклические
- Углеводы
- Подофиллотоксин
- Тетрагидронафталины
- Нафталины
- Полициклические ароматические углеводороды
- Углеводороды, ароматные
- Полициклические соединения
- Глюкозиды
- Гликозиды
- Неорганические химические вещества
- Хлорные соединения
- Азотные соединения
- Координационные комплексы
- Платиновые соединения
- Этопозид
- Карбоплатин
- Цисплатин
- Тислелизумаб
Другие идентификационные номера исследования
- QLC5508-304
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .