A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC

Официальное название

A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations

Обзор

This study is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer.

Вмешательства

• Препарат SHR-A2009 ; Aumolertinib
  SHR-A2009 administered intravenously, Aumolertinib administered orally.
• Препарат Aumolertinib
  Aumolertinib administered orally

Первичные конечные точки

• Progression-free survival (PFS) assessed by BICR according to RECIST v1.1 [Срок оценки: Up to approximately 38 months]

Вторичные конечные точки (5)

• overall survival (OS) [Срок оценки: Up to approximately 60 months]
• Progression Free Survival(PFS by investigator) [Срок оценки: Up to approximately 38months]
• Duration of response(DoR，by BICR and investigator ) [Срок оценки: Up to approximately 38 months]
• Disease control rate（DCR，by BICR and investigator） [Срок оценки: Up to approximately 38 months]
• Incidence of AEs [Срок оценки: from Day1 to 40 days after last dose]

Критерии участия

Критерии включения

• Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
• Subjects with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood specimens.
• No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer.
• At least one measurable tumor lesion according to RECIST v1.1.
• ECOG performance status of 0 or 1.
• Expected survival time ≥12 weeks.
• Adequate bone marrow and organ function.
• Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form.

Критерии исключения

• Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
• Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
• Subjects with uncontrolled tumor-related pain, as determined by the investigator.
• Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
• Insufficient time interval between prior antitumor therapy and the first dose administration.
• Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
• History of other malignancies within ≤5 years prior to the first dose.
• Subjects with a history of interstitial lung disease, or imaging at screening suggestive of suspected interstitial lung disease; or other moderate to severe pulmonary diseases severely affecting lung function.
• Severe cardiovascular or cerebrovascular diseases.
• Any severe or uncontrolled ocular lesions that, in the physician's judgment, may increase the patient's safety risk.
• Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
• Severe infections within 4 weeks prior to the first dose.
• Subjects with arterial/venous thromboembolic events within 6 months prior to the first dose of the study drug.
• Active tuberculosis infection.
• History of immunodeficiency, including positive HIV test.
• Active hepatitis B or hepatitis C.
• Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.
• History of severe allergic reactions to aumolertinib or other monoclonal antibodies, or hypersensitivity to any component of SHR-A2009.
• Known history of alcohol or drug dependence or drug abuse.
• Psychiatric disorders or poor compliance.

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

• Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07183189 · SHR-A2009-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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