A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC

Официальное название

A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC

Обзор

This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.

Вмешательства

• Препарат SHR-1826；Adebrelimab；SHR-8068；Bevacizumab
  Drug: Drug: SHR-1826 Administration by intravenous infusion for a cycle of 3 weeks. Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks. Drug: SHR-8068 Administration by intravenous infusion for a cycle of 6 weeks. Drug: Bevacizumab Administration by intravenous infusion for a cycle of 3 weeks.

Первичные конечные точки

• Incidence and severity of adverse events (AEs) /serious adverse events(SAEs) [Срок оценки: approximately 2 years]
• Overall response rate (ORR) [Срок оценки: approximately to 2 years]

Вторичные конечные точки (4)

• Duration of response (DoR) [Срок оценки: approximately to 2 years]
• Disease control rate (DCR) [Срок оценки: approximately to 2 years]
• Progression-free survival (PFS) [Срок оценки: approximately to 2 years]
• Overall survival (OS) [Срок оценки: approximately to 5 years after last subject enrolled]

Критерии участия

Критерии включения

• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• ECOG performance score of 0-1.
• Life expectancy ≥ 3 months.
• Have at least one measurable tumor lesion per RECIST v1.1.
• Subjects with histologically confirmed locally advanced or metastatic NSCLC.
• Good level of organ function.
• Provide archived or fresh tumor tissue for vendor test.

Критерии исключения

• Subjects with active central nervous system metastases or meningeal metastases;
• History of serious cardiovascular and cerebrovascular diseases;
• Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
• Severe infection within 4 weeks prior to the first dose;
• Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
• Subjects with uncontrolled tumor-related pain;
• Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
• Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
• Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0);
• History of immunodeficiency, including a positive HIV test;
• Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

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

Китай · 1 центр

• Chinese People's Liberation Army (PLA) General Hospital — Пекин

Идентификаторы

NCT: NCT06844474 · SHR-1826-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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