Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC

Официальное название

A Prospective, Single-Arm, Exploratory Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced Non-Small Cell Lung Cancer

Обзор

The study enrolled patients with advanced or metastatic NSCLC harboring HER2 mutations, amplification, or overexpression who had progressed after ≥1 prior lines of anticancer therapy. After enrollment, participants received treatment with rezetamab plus pertuzumab until disease progression, intolerable toxicity, withdrawal of consent, or other conditions requiring treatment discontinuation.

Подробное описание

Patients who meet the following criteria are enrolled:

Aged 18-75 years Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition) Pathologically documented HER2 mutation, amplification, or overexpression Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease Received SHR-A1811 combined with pertuzumab

Вмешательства

• Препарат SHR-A1811
  Intravenous infusion, q3 week, SHR-A1811 combined with pertuzumab

Первичные конечные точки

• Progression Free Survival (PFS) by investigator assessment [Срок оценки: Until progression, assessed up to approximately 2 years]

Вторичные конечные точки (5)

• Objective Response Rate （ORR） [Срок оценки: Two years after the last subject was enrolled in the group]
• Overall Survival (OS) [Срок оценки: Until death, assessed up to approximately 3 years]
• Disease Control Rate (DCR) [Срок оценки: Two years after the last subject was enrolled in the group]
• Duration of Response (DOR) [Срок оценки: Two years after the last subject was enrolled in the group]
• AE [Срок оценки: until to 90 days after the last dose，assessed up to approximately 3 years]

Критерии участия

Критерии включения

• Aged 18-75 years
• Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition)
• Pathologically documented HER2 mutation, amplification, or overexpression
• Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease
• There is at least one measurable lesion according to RECIST V1.1 criteria
• ECOG score of 0 or 1.
• The expected survival is ≥12 weeks

Критерии исключения

• There are untreated or active central nervous system (CNS) tumor metastases
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
• Pleural, ascites, or pericardial effusion requiring intervention occurred within 14 days prior to initial administration
• Systemic antitumor therapy was performed 4 weeks prior to study initiation
• Subjects who have previously received HER2-targeted therapy (excluding pan-HER tyrosine kinase inhibitors) or antibody-drug conjugates with a topoisomerase I inhibitor payload.
• Use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within less than 5 drug half-lives prior to the first dose.
• Has active infection requiring systemic treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07377916 · ES-2025-235-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗