Идёт набор NCT07373964

A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD-L1 Inhibitor, Carboplatin, and Etoposide as First-Line Treatment in Patients With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)

Фаза II С лечением 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: Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide.
Кому может быть актуально: Состояния в реестре: Small Cell Lung Cancer. Базовые параметры: 18 лет — 75 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 Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Tablets Combined With PD-L1 Inhibitor, Carboplatin, and Etoposide as First-Line Treatment in Patients With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)

Обзор

This is a Phase II, single-arm, single-center study evaluating Chidamide combined with a PD-L1 inhibitor, carboplatin, and etoposide as first-line therapy in extensive-stage small-cell lung cancer (ES-SCLC) patients. The primary objective is to assess Progression-Free Survival (PFS) per RECIST v1.1. Secondary objectives include Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (OS), and safety. Approximately 36 participants will receive induction therapy (Chidamide + chemotherapy + PD-L1 inhibitor) for 4 cycles, followed by Chidamide maintenance until progression or unacceptable toxicity.

Вмешательства

Препарат Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide
Induction Phase: Chidamide 15 mg orally on days 1, 4, 8, 11, 15, and 18 of each 21-day cycle for 4 cycles.PD-L1 inhibitor, carboplatin, and etoposide are administered per their respective prescribing information. Maintenance Phase: Chidamide 20 mg orally twice weekly (at least 3 days apart) until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.PD-L1 inhibitor is administered per their respective prescribing information.

Первичные конечные точки

Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator. [Срок оценки: baseline up to approximately 24 months]

Вторичные конечные точки (5)

Objective Response Rate (ORR) per RECIST v1.1. [Срок оценки: baseline up to approximately 24 months]
Disease Control Rate (DCR) per RECIST v1.1. [Срок оценки: baseline up to approximately 24 months]
Duration of Response (DOR) per RECIST v1.1 [Срок оценки: baseline up to approximately 24 months]
Overall Survival (OS) [Срок оценки: baseline up to approximately 24 months]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: baseline up to approximately 24 months]

Критерии участия

Критерии включения

Age ≥18 and ≤75 years.
Histologically confirmed ES-SCLC, unsuitable for local radical therapy.
No prior systemic therapy for ES-SCLC.
ECOG performance status 0-1.
At least one measurable lesion per RECIST v1.1.
Expected survival ≥3 months.
Adequate organ function (hematological, hepatic, renal, cardiac).
Effective contraception from consent until 180 days after last dose.
For active HBV infection: HBV DNA <2000 IU/mL within 28 days before treatment and on stable antiviral therapy.
Recovery from prior therapy toxicities to ≤ Grade 1 (except alopecia).
Signed informed consent.