- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07583550
Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer
Efficacy and Safety of Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy and Sequential Adebrelimab Maintenance Therapy for Extensive-stage Small Cell Lung Cancer: A Prospective, Multicenter Phase II Study
Обзор исследования
Статус
Условия
Подробное описание
This study plans to prospectively enroll 43 subjects with extensive-stage small cell lung cancer (ES-SCLC) without malignant pleural effusion from multiple centers. All subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy/fraction × 10 fractions, BID). Within one week after radiotherapy completion, subjects will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined with adebrelimab (anti-PD-L1 antibody), followed by adebrelimab maintenance therapy for two years. Through this regimen, we aim to achieve survival outcomes comparable to or even superior to those of the MATCH study from West China Hospital (median PFS 6.9 months, median OS 16.9 months) and the NCT04562337 study from Shandong Cancer Hospital (median PFS 10.1 months, median OS 21.4 months), with manageable toxicity profiles.
Additionally, immunohistochemistry (IHC) will be performed to detect the expression levels of four key transcriptional proteins-YAP1, NEUROD1, ASCL1, and POU2F3-which are used to guide the molecular subtyping of small cell lung cancer. Based on these results, we will investigate the differential efficacy of this treatment regimen across distinct molecular subtypes (A/N/P/Y/I/AN/QN), with the goal of identifying the subject population most likely to benefit from this approach and ultimately better serving clinical practice.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed SCLC;
- No malignant pleural effusion or pericardial effusion;
- No prior history of thoracic radiotherapy or thoracic surgery;
- No prior systemic anti-tumor therapy;
- ECOG performance status 0-2, with a life expectancy of ≥12 weeks;
- At least one measurable lesion per RECIST 1.1 criteria;
- No history of interstitial pneumonia;
- No history of immune-related pneumonitis;
- No history of autoimmune diseases;
- No history of significant active pulmonary infection;
- No use of corticosteroid therapy within 14 days prior to enrollment;
- No Grade ≥3 hematologic toxicity or hepatic/renal impairment;
- No brainstem metastases and no significant neurological symptoms;
- For subjects with coexisting HBV/HCV infection, hepatic impairment ≤ Grade 1 after prior active antiviral therapy;
- All subjects have provided written informed consent;
Exclusion Criteria:
- Presence of interstitial pneumonia or infectious fever prior to treatment;
- Comorbid autoimmune diseases or long-term oral corticosteroid use (including those who received oral corticosteroids within 14 days prior to treatment);
- Prior history of thoracic radiotherapy or thoracic surgery;
- Presence of Grade ≥3 hematologic toxicity or hepatic/renal impairment;
- Hypersensitivity to adebrelimab;
- Significant respiratory symptoms that preclude tolerance to radiotherapy;
- Active hepatitis B or C infection, currently on antiviral therapy, and with liver function impairment of Grade 2 or above;
- Presence of pleural effusion or pericardial effusion;
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Low-Dose Radiotherapy + EP/EC + Adebrelimab
All subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy per fraction × 10 fractions, BID).
Within one week after radiotherapy completion, they will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined concurrently with adebrelimab.
Following the 4-6 cycles of chemo-immunotherapy, adebrelimab maintenance therapy will be continued for two years.
|
20 mg/kg intravenously on day 1, repeated every 21 days (q3w).
Administered concurrently with chemotherapy for 4-6 cycles, followed by maintenance monotherapy for up to 2 years.
Etoposide 100 mg/m² on days 1-3 plus cisplatin 25 mg/m² on days 1-3, every 3 weeks (q3w), or etoposide 100 mg/m² on days 1-3 plus carboplatin AUC 5 on day 1, every 3 weeks (q3w).
Etoposide (100 mg/m²) and cisplatin (25 mg/m²) were administered on days 1-3 of each 3-week cycle.
Etoposide (100 mg/m²) was given on days 1-3 and carboplatin (AUC 5) on day 1 of each 3-week cycle.
All subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy per fraction × 10 fractions, BID).
Within one week after radiotherapy completion, they will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined concurrently with adebrelimab.
Following the 4-6 cycles of chemo-immunotherapy, adebrelimab maintenance therapy will be continued for two years.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Progression-Free Survival(PFS)
Временное ограничение: From the date of first radiotherapy to the date of first documented disease progression, metastasis.
|
Progression-free survival (PFS), defined as the time from the initiation of radiotherapy to the first documented disease recurrence/progression, metastasis, or death from any cause.
|
From the date of first radiotherapy to the date of first documented disease progression, metastasis.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
Временное ограничение: From date of first low-dose radiotherapy to 30 days after last dose.
|
Frequency, severity, and relationship of adverse events assessed by CTCAE v5.0.
|
From date of first low-dose radiotherapy to 30 days after last dose.
|
|
Overall Survival (OS)
Временное ограничение: From date of first radiotherapy to date of death from any cause, assessed up to 36 months.
|
Overall survival (OS), defined as the time from the initiation of radiotherapy to death from any cause.
|
From date of first radiotherapy to date of death from any cause, assessed up to 36 months.
|
|
Overall Response Rate (ORR)
Временное ограничение: Baseline (within 28 days prior to first dose), then every 8 weeks (±7 days) from radiotherapy initiation until 2 years post-treatment.
|
The objective response rate (ORR), defined as the proportion of subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria based on evaluable lesions in the lungs and distant metastases (including primary tumor, lymph nodes, and distant metastatic lesions), relative to the total enrolled population.
|
Baseline (within 28 days prior to first dose), then every 8 weeks (±7 days) from radiotherapy initiation until 2 years post-treatment.
|
|
Disease Control Rate (DCR)
Временное ограничение: Baseline (within 28 days prior to first dose), then every 8 weeks (±7 days) from radiotherapy initiation until 2 years post-treatment.
|
The disease control rate (DCR), defined as the proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 criteria based on evaluable lesions in the lungs and distant metastases (including primary tumor, lymph nodes, and distant metastatic lesions), relative to the total enrolled population.
|
Baseline (within 28 days prior to first dose), then every 8 weeks (±7 days) from radiotherapy initiation until 2 years post-treatment.
|
|
To investigate the association between distinct molecular subtypes and clinical outcomes, including prognosis and treatment-related toxicity.
Временное ограничение: Baseline: collect tumor tissue (archived FFPE or fresh biopsy) prior to treatment initiation; prognosis follow-up until progression or death (imaging q6w, survival q3m); toxicity monitoring until 30 days post-last dose (recorded at each visit).
|
Immunohistochemistry (IHC) for YAP1, NEUROD1, ASCL1, and POU2F3 to determine molecular subtypes; prognosis assessed via Kaplan-Meier and Cox regression; toxicity graded per CTCAE v5.0.
|
Baseline: collect tumor tissue (archived FFPE or fresh biopsy) prior to treatment initiation; prognosis follow-up until progression or death (imaging q6w, survival q3m); toxicity monitoring until 30 days post-last dose (recorded at each visit).
|
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
- 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
Другие идентификационные номера исследования
- 2026 049 A
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. .