Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

Официальное название

Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): an Multicenter, Single Arm Prospective Trial

Обзор

This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.

Вмешательства

• Препарат Tislelizumab
  Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).
• Препарат Etoposide
  Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).
• Препарат Carboplatin or Cisplatin
  Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).
• Лучевая терапия Thoracic radiotherapy
  IMRT 30-45Gy/10-15f

Первичные конечные точки

• Progression-free Survival (PFS) [Срок оценки: Up to 2 years]

Вторичные конечные точки (4)

• Objective Response Rate (ORR) [Срок оценки: Up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 2 years]
• Overall Survival （OS） [Срок оценки: Up to 2 years]
• Adverse events [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays), male or female, at the time of signing the informed consent form;
• Confirmed small cell lung cancer of extensive stage by histology or cytology;
• At least one measurable lesion by imaging studies (according to RECIST 1.1) with a long diameter of ≥10 mm as examined by spiral CT or MRI;
• Within 3 days prior to treatment, an ECOG score of 0 to 1;
• No prior antitumor treatment for extensive stage disease (if the patient has previously received chemotherapy and/or radiotherapy in the limited stage of SCLC, the treatment intent must have been curative, and there must be at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive stage SCLC);
• Expected life span of ≥3 months;
• Good function of vital organs;
• The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.

Критерии исключения

• Concurrent severe respiratory diseases: such as pulmonary fibrosis;
• Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and severe primary diseases of the heart, brain, liver, or kidneys;
• Uncontrolled active infections;
• Known or suspected allergies to the study medication and its excipients;
• Female patients who are pregnant or breastfeeding, or women of childbearing potential with a positive baseline pregnancy test;
• Prior use of antitumor treatment targeting the PD-(L)1 pathway.

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 · 6 центров

• Jincheng General Hospital — Jincheng
• Jinzhong third people's hospital — Jinzhong
• Second Hospital of Shanxi Medical University — Taiyuan
• Shanxi Bethune Hospital — Taiyuan
• Shanxi Hospital of Traditional Chinese Medicine — Taiyuan
• TISCO General Hospital — Taiyuan

Идентификаторы

NCT: NCT06536868 · [2024] YX No. 274

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗