Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Resectability rate
研究概览
简要总结
The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent provided.
- •Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.
- •ECOG score is 0 or
- •Adequate hematological function, liver function and renal function.
排除标准
- •Previously received systemic anti-tumor therapy for non-small cell lung cancer.
- •history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.
- •History or active pulmonary tuberculosis.
- •Active infections that require systemic treatment.
- •History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.
- •Untreated active Hepatitis B.
- •Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
- •Grade 3 or above peripheral neuropathy.
- •Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs.
- •Underlying severe or uncontrolled disease.
- •Malignant tumors other than NSCLC within 5 years.
- •Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of >10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.
研究组 & 干预措施
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
干预措施: Tislelizumab (Drug)
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
干预措施: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC) (Drug)
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Resectability rate
时间窗: At time of surgery
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
次要结局
- Perioperative G3-4 Adverse Events (AEs)(Up to 1 month post surgery)
- Major pathological response rate (MPR)(At time of surgery)
- Pathology complete response rate(pCR)(At time of surgery)
- R0 Resection rate(At time of surgery)