A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations

Официальное название

A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

Обзор

The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations

Вмешательства

• Препарат SHR-A1811
  Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)
• Препарат PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
  Drug: PD-1/PD-L1 inhibitors administered intravenously every 3 weeks (Q3W) Drug: Pemetrexed Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Paclitaxel Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Carboplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Cisplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)

Первичные конечные точки

• Progression-free survival (PFS) based on blinded independent central review (BICR) [Срок оценки: Until progression, assessed up to approximately 2 years]

Вторичные конечные точки (3)

• Overall Survival (OS) [Срок оценки: Until death, assessed up to approximately 3 years]
• Progression Free Survival (PFS) by investigator assessment [Срок оценки: Until progression, assessed up to approximately 2 years]
• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) [Срок оценки: until to 90 days after the last dose，assessed up to approximately 3 years]

Критерии участия

Критерии включения

• Able and willing to provide a written informed consent
• 18-75 years old (inclusive of both ends)
• ECOG score of 0 or 1.
• Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
• Subjects with central laboratory- confirmed functional HER2 mutations
• No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
• Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
• Protocol-defined adequate organ function including cardiac, renal, hepatic function

Критерии исключения

• Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
• Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
• Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
• With poorly controlled tumor-related pain.
• previous or current with other malignancies.
• Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
• Subjects with active or previous autoimmune diseases.
• Subjects with uncontrolled or severe cardiovascular diseases.
• Subjects with active hepatitis B or hepatitis C.

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

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT06430437 · SHR-A1811-310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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