SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC

Официальное название

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SHR-A1811 Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With HER2 Abnormalities

Обзор

This is a phase II, open-label, single-arm study evaluating the efficacy and safety of SHR-A1811 (a HER2-targeted ADC) combined with AK112 (a PD-1/VEGF bispecific antibody) in patients with HER2-amplified or overexpressed locally advanced or metastatic NSCLC.

Подробное описание

The study consists of two cohorts: Cohort 1 includes patients who failed standard first-line therapy; Cohort 2 includes treatment-naïve patients. Patients will receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.

Вмешательства

• Препарат SHR-A1811 plus AK112
  Patients will receive the combination of SHR-A1811 and AK112 until disease progression or until other predefined discontinuation criteria are met, whichever occurs first.

Первичные конечные точки

• PFS [Срок оценки: From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.]

Вторичные конечные точки (6)

• DOR [Срок оценки: From the date of first documented objective response to the date of first documented disease progression or death from any cause prior to progression, whichever occurs first, assessed up to approximately 36 months.]
• ORR [Срок оценки: From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months.]
• OS [Срок оценки: From date of first study treatment to date of death from any cause, assessed up to approximately 36 months.]
• Adverse Events [Срок оценки: From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.]
• Serious Adverse Events [Срок оценки: From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.]
• Treatment-Related Adverse Events [Срок оценки: From first dose of study treatment through 90 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first.]

Критерии участия

Критерии включения

• Signed ICF.
• Age 18-75.
• ECOG PS 0-1.
• Life expectancy ≥3 months.
• Histologically/cytologically confirmed locally advanced or metastatic/recurrent NSCLC, not eligible for curative surgery or definitive chemoradiotherapy.
• Cohort 1: Failed prior first-line systemic therapy, with HER2 amplification or overexpression . Cohort 2: No prior systemic therapy, with HER2 amplification/overexpression .
• ≥1 measurable lesion per RECIST 1.1.
• Adequate organ and bone marrow function.
• Use of effective contraception.

Критерии исключения

• History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.
• Arterial/venous thrombotic event within 6 months.
• Significant cardiovascular disease.
• Active autoimmune disease requiring systemic treatment.
• Use of systemic immunosuppressants within 2 weeks prior.
• Symptomatic pleural/pericardial/ascitic effusion requiring drainage.
• Symptomatic, progressive, or diffusely spread CNS metastases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07489703 · MA-NSCLC-II-062

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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