A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)

Официальное название

A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.

Обзор

The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).

Подробное описание

This is a randomized, open-label, multicenter, Phase III clinical study. Participants with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR) will be enrolled and randomized in a 1:1 ratio to experimental (SYS6010 + Enlonstobart) or control (Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen) group. Random factors include disease stage (Stage II / IIIA vs. Stage IIIB), Pathological type (non-squamous cell carcinoma vs. squamous cell carcinoma), and lymph node status (positive vs. negative).

Вмешательства

• Препарат SYS6010
  SYS6010
• Препарат Enlonstobart
  Enlonstobart
• Препарат Tislelizumab
  administered via Intravenous (IV) injection
• Препарат Toripalimab ±+platinum-based doublet chemotherapy
  Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
• Препарат Durvalumab
  Durvalumab
• Препарат Pembrolizumab
  Pembrolizumab
• Препарат Nivolumab
  Nivolumab

Первичные конечные точки

• Disease-Free Survival (DFS) assessed by the independent review committee (IRC) [Срок оценки: Up to approximately 60 months]

Вторичные конечные точки (6)

• Overall Survival (OS) [Срок оценки: Up to approximately 60 months]
• DFS assessed by investigators [Срок оценки: Up to approximately 60 months]
• Incidence and severity of Adverse Events (AEs) [Срок оценки: Approximately 15 months]
• EORTC QLQ-30 questionnaire [Срок оценки: Approximately 13 months]
• Blood concentration of SYS6010 and Enlonstobart [Срок оценки: Approximately 13 months]
• Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs) [Срок оценки: Approximately 13 months]

Критерии участия

Критерии включения

• Able to understand and willingness to voluntarily provide written informed consent.
• Age 18 to 75 years, males or females.
• Histologically confirmed squamous or non-squamous NSCLC.
• Ability to provide qualified tumor samples.
• Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory.
• Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC).
• The International Association for the Study of Lung Cancer (IASLC) V9 Stage II-IIIB NSCLC, after confirmed complete surgical resection with resection margins proved microscopically free of disease (R0).

Критерии исключения

• Participants with a condition requiring further surgical resection, in the investigator's opinion.
• Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.
• Eligible only for incomplete resection.
• Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.
• History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment.
• Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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: NCT07672223 · SYS6010-015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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