Randomised phase III study testing nivolumab and ipilimumab versus acarboplatin based doublet in first line treatment of PS 2 or elderly (morethan 70 years old) patients with advanced non-small cell lung cancer - Lena eNERGY

CHU Rennes0 个研究点目标入组 242 人2017年9月12日

概览

暂无简介。

注册库

who.int

开始日期

2017年9月12日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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
•Presence of at least one measurable target lesion (RECIST 1\.1 rules)
•in a non\-irradiated region and analysable by CT

•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