Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC

Официальное название

Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study

Обзор

To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer

Вмешательства

• Препарат Tislelizumab, Carboplatin /Cisplatin, Etoposide
  Induction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f；

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: Baseline until PD or death, whichever occurs first or up to approximately 23 months]

Вторичные конечные точки (6)

• Objective Response Rate (ORR) [Срок оценки: Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months]
• Duration Of Response (DOR) [Срок оценки: Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months]
• Disease Control Rate (DCR) [Срок оценки: up to approximately 23 months]
• 6-moth/1-year Progression Free Survival (PFS) Rate [Срок оценки: up to approximately 23 months]
• 1-year Overall Survival (OS) rate [Срок оценки: up to approximately 23 months]
• Number Of Participants Experiencing Treatment-Emergent Adverse Events [Срок оценки: up to approximately 23 months]

Критерии участия

Критерии включения

• Age≥18 years old, male or female, signed Informed Consent Form (ICF);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Histologically or cytologically confirmed ES-SCLC;
• No prior systemic treatment for ES-SCLC;
• At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
• Adequate hematologic and end organ function;

Критерии исключения

• Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
• Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
• Was administered a live vaccine ≤ 4 weeks before treatment;
• Active autoimmune diseases or history of autoimmune diseases that may relapse;
• Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;
• With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
• Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection;
• Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Anhui Cancer Hospital — Хэфэй

Идентификаторы

NCT: NCT06838208 · PRAD1 · CRTOG2501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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