A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Официальное название

Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study

Обзор

This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.

Вмешательства

• Препарат SHR-A2102
  SHR-A2102: injection, 80mg/ bottle, intravenous drip
• Препарат Adebelimab (SHR-1316)
  Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip
• Препарат SHR-8068
  SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip

Первичные конечные точки

• Determination of Recommended Phase II dose (RP2D) [Срок оценки: From first dose of study treatment until the end of Cycle 1（up to 21 days）]
• Objective Response Rate (ORR) [Срок оценки: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)]
• Incidence and severity of AEs [Срок оценки: The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days)]

Вторичные конечные точки (4)

• Disease Control Rate (DCR) [Срок оценки: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)]
• Duration of Response (DoR) [Срок оценки: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)]]
• Progression free Survival (PFS) [Срок оценки: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)]
• Overall Survival (OS) [Срок оценки: From time of first dose of objective disease progression until the date of death (up to 24 months)]

Критерии участия

Критерии включения

• Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
• Age 18\~70 years old.
• Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
• At least one measurable lesion per RECIST v1.1 criteria.
• ECOG PS score: 0-1.

Критерии исключения

• Active or symptomatic brain metastases.
• Previous diagnosis of any other malignancy.
• Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
• Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
• Uncontrolled tumor-related pain.
• Subjects with severe cardiovascular and cerebrovascular diseases.

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

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT06589778 · SHR-A2102-206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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