EUCTR2016-001063-36-FR
进行中（未招募）
1 期
Randomised phase III study testing nivolumab versus chemotherapy in first line treatment of PS 2 or elderly (more than 70 years old) patients with advanced non-small cell lung cancer - Lena eNERGY
相关药物OPDIVO
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- CHU Rennes
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Signed written informed consent
- •Cytologically or histologically proven NSCLC (adenocarcinoma, squamous cell carcinoma, large\-cell carcinoma)
- •Stage IV or non\-treatable by radiotherapy stage III (7th classification)
- •No previous systemic chemotherapy for lung cancer, except in case of relapse after adjuvant treatment for localized disease with 6 months or more between end of previous chemotherapy and relapse
- •Patients less than 70 years old and PS 2 or 70 years older PS 0 to 2
- •Judged fit enough to receive chemotherapy according to ESMO guidelines
- •Presence of at least one measurable target lesion (RECIST 1\.1 rules) in a non\-irradiated region and analysable by CT
- •Life expectancy \>12 weeks
- •Prior radiation therapy is authorized if it involved less than 25% of the total bone marrow volume and finished 14 days before D1 of planned treatment
- •Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization/registration
排除标准
- •Patients with other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, coronarian or peripheric arterial bypass operation, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, at least grade 2 peripheral neuropathy, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections) are not eligible.
- •Serious or uncontrolled systemic disease judged as incompatible with the protocol by the investigator
- •Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ, or appropriately treated localized low\-grade prostate cancer (Gleason score \< 6\), unless the initial tumor was diagnosed and definitively treated more than 5 years previously, with no evidence of relapse.
- •Known activating mutation of EGFR (del LREA exon 19, mutation L858R or L861X of exon 21, mutation G719A/S in exon 18\) or EML4\-ALK translocation.
- •Superior caval syndrome.
- •Uncontrolled infectious status
- •All concurrent radiotherapy
- •Concurrent administration of one or several other anti\-tumor therapies.
- •Psychological, familial, social or geographic difficulties preventing follow\-up as defined by the protocol.
- •Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor),
结局指标
主要结局
未指定
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