A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

Официальное название

A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

Обзор

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.

Подробное описание

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.

Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093 and adebrelimab) or the control arm (docetaxel injection). Participants in the experimental arm will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met. Participants in the control arm will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met. Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedures.

Вмешательства

• Препарат HS-20093
  Participants will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met.
• Препарат Docetaxel
  Participants will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met.

Первичные конечные точки

• Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) [Срок оценки: Approximately 3 years after the fist patient with first dose]
• Overall survival (OS) [Срок оценки: Approximately 5 years after the fist patient with first dose]

Вторичные конечные точки (6)

• PFS assessed by investigator [Срок оценки: Approximately 3 years after the fist patient with first dose]
• Objective response rate (ORR) [Срок оценки: Approximately 3 years after the fist patient with first dose]
• Disease control rate (DCR) [Срок оценки: Approximately 3 years after the fist patient with first dose]
• Duration of response (DoR) [Срок оценки: Approximately 3 years after the fist patient with first dose]
• Incidence and severity of AEs [Срок оценки: From the first dose until 90 days after the last dose]
• Incidence and severity of SAEs [Срок оценки: From the first dose until 90 days after the last dose]

Критерии участия

Критерии включения

• Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
• Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
• Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC).
• Presence of at least one measurable target lesion.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
• Minimum life expectancy >12 weeks.
• Adequate organ function.
• Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
• Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.

Критерии исключения

• Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.
• Prior or ongoing treatment with any of the following:

• Prior or current treatment targeting B7-H3;
• Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.;
• Prior treatment with docetaxel monotherapy or in combination with other agents.
• Persistent adverse reactions caused by prior treatment.
• Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms).
• History of other primary malignancies.
• Presence of any of the following abnormal cardiac findings:

• Evidence of currently clinically significant important arrhythmia or ECG abnormality;
• Presence of risk factors causing QT interval prolongation or arrhythmic events.
• Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.
• Severe or poorly controlled hypertension.
• Severe or poorly controlled diabetes mellitus.
• Clinically significant bleeding symptoms or significant bleeding tendency.
• Severe infection.
• History of severe arterial or venous thromboembolic events.
• Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
• Participants with active or history of autoimmune disease with potential for recurrence.
• Prior occurrence of severe or life-threatening immune-mediated adverse events.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07464327 · HS-20093-309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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