A Phase II Study Evaluating the Efficacy and Safety of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (pCR) rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Neoadjuvant Therapy
Neoadjuvant therapy period : Subjects will receive IBI363 for up to 4 cycles before surgery
干预措施: IBI363 (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR) rate
时间窗: Up to approximately 8 weeks following completion of neoadjuvant treatment
pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy
Safety parameters: the incidence of Treatment-related Adverse Event, (TRAEs)
时间窗: up to 90 days after the last dose
Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)
时间窗: up to 90 days after the last dose
Safety parameters: the incidence of immune-related adverse events (irAEs)
时间窗: up to 90 days after the last dose
Safety parameters: the incidence of adverse events of special interest (AESIs)
时间窗: up to 90 days after the last dose
Safety parameters: the incidence of serious adverse events (SAE)
时间窗: up to 90 days after the last dose
Safety parameters: the relatedness of infusion-related reactions (IRRs) to the investigational product and their severity
时间窗: up to 90 days after the last dose
Safety parameters: the surgery delay rate
时间窗: 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
时间窗: up to 90 days after the last dose
次要结局
- Event Free Survival (EFS)(Up to approximately 5 years)
- Major Pathological Response (mPR) Rate(Up to approximately 8 weeks following completion of neoadjuvant treatment)
- Objective Response Rate （ORR）Rate(Up to approximately 5 years)
- Disease Control Rate (DCR) Rate(Up to approximately 5 years)
- R0 resection rate(Up to approximately 8 weeks following completion of neoadjuvant treatment)