Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer

Официальное название

A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer

Обзор

This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.

Вмешательства

• Препарат SHR-8068，adebelizumab and platinum-based chemotherapy
  SHR-8068，adebelizumab and platinum-based chemotherapy
• Препарат tislelizumab, and platinum-based chemotherapy
  tislelizumab, and platinum-based chemotherapy

Первичные конечные точки

• Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR] [Срок оценки: Approximately 32 months.]
• OS [Срок оценки: Approximately 64 months.]

Вторичные конечные точки (5)

• PFS by the investigator [Срок оценки: Approximately 32 months.]
• Objective Response Rate (ORR) [Срок оценки: Approximately 32 months.]
• Duration of Response (DoR) [Срок оценки: Approximately 32 month]
• Incidence and Severity of Adverse Events (AEs) [Срок оценки: Approximately 64 months.]
• Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13) [Срок оценки: Approximately 64 months.]

Критерии участия

Критерии включения

• Voluntary participation and written informed consent.
• 18-75 years old, no gender limitation.
• Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
• Confirmed tumor PD-L1 status prior to randomization.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1
• With a life expectancy ≥ 3 months.
• At least one measurable lesion according to RECIST v1.1.

Критерии исключения

• Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
• Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
• Previous or co-existing malignancies；
• Have Active or prior documented autoimmune or inflammatory disorders;
• Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
• Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Affiliated Cancer Hospital of Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT07170995 · SHR-8068-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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