2024-519205-35-01招募中2 期
Neoadjuvant chemo-immunotherapy for stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC)
Fondazione Ricerca Traslazionale1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete tumor resection rate (R0). An R0 resection means that the surgical margin is microscopically negative for residual tumor.
研究概览
简要总结
To evaluate the rate of radical surgery (R0) in patients with stage III PD-L1 positive NSCLC treated with tislelizumab plus platinum-based doublet chemotherapy as neoadjuvant treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage III disease.
- •Age ≥ 18 years.
- •Written informed consent
- •PD-L1 TPS ≥ 1% according to local testing.
- •No evidence of EGFR mutations or ALK or ROS1 or RET rearrangements by local testing.
- •Mandatory baseline multidisciplinary assessment to confirm suitability of patient to local treatment with curative intent.
- •Pulmonary function tests within 6 months of the planned resection.
- •At least 1 measurable lesion as defined by RECIST v1.
- •ECOG Performance Status ≤
- •Eligibility to receive a platinum doublet chemotherapy regimen.
- •Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug
排除标准
- •Evidence of stage IV NSCLC (metastatic disease).
- •Histology of large cell neuroendocrine carcinoma (LCNEC).
- •Any previous therapy for current lung cancer, including chemotherapy or radiation therapy
- •Previous treatment with an antibody or drug against the immune checkpoint pathway, including but not limited to, therapeutic anti-cytotoxic T-lymphocyte antigen-4-associated antibodies (anti-CTLA-4), anti-PD-1 and anti-PD-L
- •Never smoking patients.
- •Active autoimmune diseases or history of autoimmune diseases that may recur
- •Concomitant participation in another therapeutic clinical trial.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Complete tumor resection rate (R0). An R0 resection means that the surgical margin is microscopically negative for residual tumor.
Complete tumor resection rate (R0). An R0 resection means that the surgical margin is microscopically negative for residual tumor.
次要结局
- Percentage of nodal downstaging defined as following neoadjuvant chemoimmunotherapy
- Pathological complete response (pCR) and major pathological response (MPR). pCR means 0% residual viable tumor cells in the primary tumor and sampled lymph nodes; MPR means ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes.
- Event-free survival (EFS) was defined as the time from study enrollment to any progression of disease before local treatment (surgery or radiotherapy) or recurrence of disease after local treatment (surgery or radiotherapy), progression of disease in the absence of surgery, or death from any cause.
- Overall survival (OS) was defined as the time from study enrollment to death of any cause
研究者
Federico Cappuzzo
Scientific
Fondazione Ricerca Traslazionale
研究点 (1)
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