NCT06659042招募中2 期
A Prospective, Single-arm Phase II Study of the Efficacy and Safety of Tislelizumab in Combination With Chemotherapy Perioperative Treatment for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate
研究概览
简要总结
The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent (ICF) and able to understand and comply with the study requirements and assessment schedule.
- •Male or female aged ≥18 years at the time of signing the ICF.
- •Histologically or cytologically confirmed stage II-IIIB (N2) non-squamous non-small cell lung cancer (NSCLC) (AJCC 8th edition).
- •With Known KRAS gene mutation.
- •Evaluated by medical and surgical discussion to be eligible for R0 resection with curative intent prior to study enrollment.
- •At least one measurable lesion as defined by RECIST v1.
- •Eligible to receive platinum-based doublet chemotherapy.
- •ECOG performance status score ≤
- •Adequate organ function during the screening period
- •Good cardiopulmonary function, meeting the requirements for surgical resection with curative intent.
- •Patients of childbearing potential must be willing to use effective contraception during the study and for 120 days after the last dose of tislelizumab.
排除标准
- •Patients meeting any of the following criteria are not eligible for enrollment:
- •Previously received any treatment for the current lung cancer, including radiotherapy and all systemic anti-tumor treatments, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy.
- •Presence of locally advanced, unresectable disease, regardless of disease stage or presence of metastases.
- •Received other approved systemic immunomodulatory agents (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymosin α1, and thymalfasin) within 4 weeks prior to the first dose.
- •Used any herbal medicine to control cancer within 14 days prior to the first dose of the study drug.
- •Received live or attenuated live vaccines within 4 weeks prior to enrollment or expected to require live or attenuated live vaccines during the study or within 5 months after the last dose of tislelizumab.
- •Any condition requiring systemic corticosteroid therapy (prednisone or equivalent >10 mg/day) or other immunosuppressive therapy within 14 days prior to the first dose of the study drug, which the investigator believes may affect the study treatment.
- •Active autoimmune disease requiring systemic treatment, which the investigator believes may affect the study treatment.
- •Interstitial lung disease, non-infectious pneumonitis, or uncontrolled other diseases, including diabetes, pulmonary fibrosis, acute lung disease, etc., which the investigator believes may affect the study treatment.
- •History of major diseases or clinical manifestations that may affect organ system function, which the investigator believes may affect the study treatment.
- •Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to the first dose of the study drug (including tuberculosis infection, etc.).
- •Known history of human immunodeficiency virus (HIV) infection.
- •Previously undergone allogeneic stem cell transplantation or organ transplantation.
研究组 & 干预措施
Tislelizumab plus platinum doublet chemotherapy
Experimental
干预措施: Tislelizumab (Drug)
Tislelizumab plus platinum doublet chemotherapy
Experimental
干预措施: Cisplatin (Drug)
Tislelizumab plus platinum doublet chemotherapy
Experimental
干预措施: Carboplatin (Drug)
Tislelizumab plus platinum doublet chemotherapy
Experimental
干预措施: Pemetrexed Disodium (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate
时间窗: Up to 3 months following completion of neoadjuvant treatment
次要结局
- Major pathological response (MPR) rate(Up to 3 months following completion of neoadjuvant treatment)
- Objective Response Rate (ORR)(Up to 3 years)
- Event-free survival (EFS)(Up to 3 years)
- Overall survival (OS)(Up to 3 years)
- Number of participants experiencing treatment-emergent adverse events (TEAEs)(Up to 3 years)
研究者
Feng Yao
Vice President of Shanghai Chest Hospital
Shanghai Chest Hospital
研究点 (1)
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