NL-OMON44704已完成2 期
A phase II trial evaluating the safety and efficacy of the addition of concurrent anti-PD-1 nivolumab to standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B Non-Small Cell Lung Carcinoma - Phase II trial evaluating nivolumab in stage IIIA/B NSCLC
European Thoracic Oncology Platform (ETOP)0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
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 99（—）
入选标准
- •* Histologically or cytologically confirmed locally advanced stage IIIA or III B (T0-3, N2-3 or T4 N0-3 M0) non-small cell lung carcinoma (NSCLC), according to 7th TNM classification.
- •* Nodal status N2 or N3 need to be proven (by biopsy, EBUS, mediastinoscopy or thoracoscopy) except for overt cT4 disease.
- •* Measurable disease according to RECIST v1.1.
- •* Previous delivery of a maximum of one 3-weekly cycle of platinum-based chemotherapy.
- •* ECOG performance status 0-1.
- •* Adequate hepatic, haematological and renal function.
- •* All AEs from previous therapies (including the first chemotherapy cycle in the context of this trial) resolved to grade <2 (except fatigue, alopecia, nausea lack of appetite or peripheral neuropathy)
排除标准
- •* Metastatic disease (as determined by PET-CT and brain MRI (preferred) or highquality brain CT with intravenous contrast at the time of staging, performed within 28 days before the beginning of first chemotherapy cycle).
- •* Previous radiotherapy to the chest, including radiotherapy for breast cancer.
- •* Prior chemotherapy, radiotherapy or molecular targeted therapy for NSCLC (with the exception of one cycle of chemotherapy given prior to enrolment into this trial).
- •* Active, known or suspected autoimmune disease
研究者
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