Идёт набор NCT06775275

A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC

Фаза II С лечением Resectable Lung Non-Small Cell Carcinoma

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: Adebellizumab, Bevacizumab, Platinum-based chemotherapy.
Кому может быть актуально: Состояния в реестре: Resectable Lung Non-Small Cell Carcinoma. Базовые параметры: 18 лет — 65 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: Китай
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 Randomized Phase II Study of Adebrelimab in Combination with Chemotherapy with or Without Bevacizumab Neoadjuvant Therapy for Resectable Non-Squamous Non-Small Cell Lung Cancer

Обзор

This is a prospective, multicenter, randomized, uncontrolled Phase II study to assess the efficacy and safety of adebrelimab in combination with chemotherapy with or without bevacizumab for the treatment of resectable Stage II-IIIB (T3N2) NSQ-NSCLC and to explore biomarkers associated with efficacy.

Подробное описание

Neoadjuvant therapy with experimental treatment followed by surgery.

Вмешательства

Препарат Adebellizumab
adebrelimab
Препарат Bevacizumab
bevacizumab
Препарат Platinum-based chemotherapy
paclitaxel or albuminotaxol or docetaxel combined with platinum, pemetrexed combined with platinum. Platinums include carboplatin, cisplatin and nedaplatin.

Первичные конечные точки

Pathological complete response [Срок оценки: After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery.]

Вторичные конечные точки (4)

Major Pathological response [Срок оценки: After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery.]
Overall response rate [Срок оценки: After 4 cycles of neoadjuvant therapy(3 weeks per cycle), before surgical resection was performed（at intervals of 4-6 weeks）.]
event free survival [Срок оценки: from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause, whichever came first, assessed up to 24 months.]
safety [Срок оценки: Safety follow-up will be conducted 30 ± 7 days after the last use of bevacizumab/chemotherapy or 90 ± 7 days after the last use of adebrelimab/surgery (whichever occurs later) to track the relief of AE. Incidence of AE/SAE/TRAE will be recorded.]

Критерии участия

Критерии включения

Resectable NSQ NSCLC
Age 18-65 years
male or female
ECOG 0-1
Subjects have not received surgery, chemotherapy, radiotherapy and biological treatment of treatment-naive non-squamous non-small cell lung cancer
Subjects must have adequate pulmonary function for the intended pneumonectomy;