A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

Официальное название

A Randomized, Open-Label, Multicenter Phase III Trial of HRS-7058 Versus the Investigator-Selected KRAS G12C Inhibitor in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

Обзор

The study is being conducted to evaluate the efficacy, and safety of HRS-7058 in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

Вмешательства

• Препарат HRS-7058
  HRS-7058
• Препарат Fulzerasib Tablets
  600mg BID
• Препарат Garsorasib Tablets
  600mg BID
• Препарат Glecirasib Citrate Tablets
  800mg QD

Первичные конечные точки

• PFS based on BICR evaluation [Срок оценки: about 32 months]

Вторичные конечные точки (7)

• OS [Срок оценки: about 45 months]
• PFS based on researcher 's assessment [Срок оценки: about 32 months]
• ORR based on researchers and BICR assessment [Срок оценки: about 45 months]
• DoR based on researchers and BICR evaluation [Срок оценки: about 45 months]
• DCR based on researcher and BICR assessment [Срок оценки: about 45 months]
• The incidence and severity of adverse events ( AE ) [Срок оценки: about 45 months]
• the occurrence of severe adverse events ( SAE ) [Срок оценки: about 45months]

Критерии участия

Критерии включения

• Age 18 years old to 75 years old ( including both ends ), regardless of gender ;
• Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer ;
• Histological specimens confirmed the presence of KRAS G12 C mutation ;
• Participants who have failed at least one line of systemic anti-tumor treatment in the locally advanced or metastatic stage. Previous systemic anti-tumor treatment should include : platinum-containing double-agent chemotherapy and immune checkpoint inhibitor therapy ( synchronous or sequential, except that the researchers determine that it is not suitable for immune checkpoint inhibitors or chemotherapy ) ;
• At least one measurable lesion conforming to the definition of RECIST v1.1 standard ;
• ECOG physical score 0-1 points ;
• Expected survival time ≥ 12 weeks ;
• Have adequate bone marrow and organ function
• Subjects were required to give informed consent to this study before the trial and voluntarily sign a written informed consent form.

Критерии исключения

• Subjects with active central nervous system ( CNS ) metastasis ;
• Other malignant tumors occurred within 5 years before the first administration, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection.
• Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug ;
• Subjects with a history of interstitial pneumonia or suspected interstitial pneumonia by imaging examination during screening ; or other lung diseases that seriously affect lung function ;
• Have serious cardiovascular and cerebrovascular diseases
• Severe infection occurred within 4 weeks before the first administration.
• The first study of arterial / venous thrombosis events within 3 months before medication was conducted.
• Have a history of immunodeficiency, including HIV test positive ;
• There is active hepatitis B or hepatitis C ;
• Subjects with active central nervous system ( CNS ) metastasis ;

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

• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07601048 · HRS-7058-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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