IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer

Официальное название

A Phase II Study Evaluating the Efficacy and Safety of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer

Обзор

This is a Phase 2 study to evaluate the safety, and efficacy of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer.

Вмешательства

• Препарат IBI363
  Subjects will receive IBI363 for up to 4 cycles, each cycle is 21 days, the first treatment cycle is 28 days

Первичные конечные точки

• Pathologic Complete Response (pCR) rate [Срок оценки: Up to approximately 8 weeks following completion of neoadjuvant treatment]
• Safety parameters: the incidence of Treatment-related Adverse Event, (TRAEs) [Срок оценки: up to 90 days after the last dose]
• Safety parameters: the incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: up to 90 days after the last dose]
• Safety parameters: the incidence of immune-related adverse events (irAEs) [Срок оценки: up to 90 days after the last dose]
• Safety parameters: the incidence of adverse events of special interest (AESIs) [Срок оценки: up to 90 days after the last dose]
• Safety parameters: the incidence of serious adverse events (SAE) [Срок оценки: up to 90 days after the last dose]
• Safety parameters: the relatedness of infusion-related reactions (IRRs) to the investigational product and their severity [Срок оценки: up to 90 days after the last dose]
• Safety parameters: the surgery delay rate [Срок оценки: Up to approximately 8 weeks following completion of neoadjuvant treatment]
• Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests,, routine urine tests, pregnancy tests，ECG, etc [Срок оценки: up to 90 days after the last dose]

Вторичные конечные точки (5)

• Event Free Survival (EFS) [Срок оценки: Up to approximately 5 years]
• Major Pathological Response (mPR) Rate [Срок оценки: Up to approximately 8 weeks following completion of neoadjuvant treatment]
• Objective Response Rate （ORR）Rate [Срок оценки: Up to approximately 5 years]
• Disease Control Rate (DCR) Rate [Срок оценки: Up to approximately 5 years]
• R0 resection rate [Срок оценки: Up to approximately 8 weeks following completion of neoadjuvant treatment]

Критерии участия

Критерии включения

• Males and Females, age ≥18 years and ≤75 years;
• Histologically or cytologically confirmed primary NSCLC:

• Stage II, IIIA or IIIB (N2) NSCLC (per AJCC8);
• No administration of any anti-NSCLC therapy in the pre-operative period;
• Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
• Participants without EGFR mutations or ALK translocation;
• PD-L1 expression: TPS≥1%
• At least 1 measurable lesion per RECISIT v1.1;
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
• Adequate organ function confirmed at screening period.

Критерии исключения

• Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;
• Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
• Pancoast tumor;
• Malignant tumor nodule in the contralateral lung lobe;
• Participants with known or suspected brain metastases or other distant metastases;
• Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;
• Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;
• Clinically significant cardiovascular or cerebrovascular disease , or history of any thromboembolic event within 6 months prior to the first dose of the study drug;
• History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or severe impairment of pulmonary function or who are suspected to have these diseases by imaging during the screening period;
• Active or uncontrolled diseases or conditions;
• History of immunodeficiency disease; 12 Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.

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

Китай · 1 центр

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07402070 · CIBI363C202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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