IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

Официальное название

A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

Обзор

This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.

Вмешательства

• Препарат Pemetrexed
  500 mg/m2 D1 IV Q3W
• Препарат Cisplatin
  75 mg/m2 D1 IV Q3W
• Препарат IBI363
  1.5 mg/kg D1 IV Q3W
• Препарат Carboplatin
  AUC 5 mg/ml/min D1 IV Q3W
• Препарат Keytruda
  200mg D1 IV Q3W

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 all adverse events (AEs) [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 non-squamous NSCLC:

• Stage IB, 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;
• At least 1 measurable lesion per RECIST 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;
• History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;
• History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;
• History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;
• Active or uncontrolled diseases or conditions;
• History of immunodeficiency disease;
• 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Liaoning Cancer Hospital and Institute — Шэньян

Идентификаторы

NCT: NCT07122687 · CIBI363C201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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