CTIS2023-504536-18-00进行中(未招募)1 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. - SAKK 16/18
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+(—)
- 性别
- All
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 2016. 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)
研究者
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