2023-504536-18-00招募中2 期
Immune-modulatory radiotherapy to enhance the effects of neoadjuvant PD-L1 blockade after neoadjuvant chemotherapy in patients with resectable stage III(N2) non-small cell lung cancer (NSCLC). A multicenter phase II trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Event-free survival (EFS) at 12 months
研究概览
简要总结
To evaluate whether the addition of immune-modulatory radiotherapy to standard neoadjuvant chemotherapy with cisplatin/docetaxel and peri-operative immunotherapy with the anti-PD-L1 antibody durvalumab in primarily resectable stage III(N2) NSCLC is efficacious and feasible.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Follow up
- 盲法
- None
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 (cytology is accepted if histology is not possible) confirmed NSCLC (adeno-, squamous-, large cell carcinoma, or NSCLC not otherwise specified (NOS)) irrespective of genomic aberrations or PD-L1 expression status
- •Tumor stage T1-4>7 N2 M0 (i.e. T1-3 N2 or T4 N2 but T4 only allowed if due to size > 7cm, not allowed if due to invasion or nodule in different ipsilateral lobe), according to the TNM classification, 8th edition, December
- •Mediastinal lymph node staging has to follow the process chart.
- •Age 18-75 years at time of registration
- •WHO performance status 0-1
- •Adequate organ function (incl. eGFR ≥ 60 mL/min)
排除标准
- •Presence of any distant metastasis or N3 disease. Brain metastases have to be excluded by CT or MRI
- •Sulcus superior tumors (Pancoast tumors) or T4 for any other reason than size >7cm
- •Any previous treatment for NSCLC
- •Any previous treatment with immune checkpoint inhibitors, including durvalumab
- •Previous radiotherapy to the chest (with the exception of tangential breast irradiation with minimal dose to lung and mediastinum, and superficial orthovoltage or electron irradiation of localized skin lesions)
- •Preexisting peripheral neuropathy (> Grade 1)
结局指标
主要结局
Event-free survival (EFS) at 12 months
Event-free survival (EFS) at 12 months
次要结局
- Event-free survival (EFS)
- Recurrence-free survival (RFS) after R0 resection
- Overall survival (OS)
- Objective response (OR) after neoadjuvant chemotherapy
- OR after neoadjuvant immunotherapy and immune-modulatory radiotherapy
- Pathological complete response (pCR)
- Local major pathological response (MPR)
- Overall major pathological response (oMPR)
- Rate of nodal down-staging to < ypN2
- Complete resection rate
- Pattern of recurrence (loco-regional, distant)
- Adverse events (AEs) and surgical complications
- Delay in surgery
- Postoperative 30-day mortality
研究者
Medical Advisor
Scientific
Swiss Group for Clinical Cancer Research
研究点 (1)
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