EUCTR2017-002842-60-FR进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CHU Rennes
- 入组人数
- 242
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •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
- •? WBC = 2000/µL
- •? Neutrophils = 1500/µL
- •? Platelets = 100 x103/µL
- •? Hemoglobin > 10.0 g/dL
- •? Serum creatinine = 1.5 x ULN or creatinine clearance (CrCl) = 45
- •mL/min (if using the Cockcroft-Gault formula below):
- •Female CrCl = (140 - age in years) x weight
- •in kg x 0.85
- •72 x serum creatinine in mg/dL
- •Male CrCl = (140 - age in years) x weight
- •in kg x 1.00
- •72 x serum creatinine in mg/dL
- •? AST/ALT = 3 x ULN
- •? Total Bilirubin = 1.5 x ULN (except Patients with Gilbert Syndrome,
- •who can have total bilirubin < 3.0 mg/dL)
- •Availability of adequate FFPE tumor-derived material (tumor blocks or slides) from a biopsy, surgery or fine needle aspirate for analysis of PDL1 testing by IHC
- •Age and Reproductive Status
- •Women of childbearing potential (WOCBP) must use appropriate
- •method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for
- •nivolumab to undergo five half-lives) after the last dose of
- •investigational drug
- •Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab
- •Women must not be breastfeeding
- •Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
- •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),
- •Concurrent participation in another clinical trial
- •Patients are excluded if they have active brain metastases or
- •leptomeningeal metastases. Patients with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for [lowest minimum is 4 weeks or more] after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
- •Patients should be excluded if they have an active, known or
- •suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- •Patients should be excluded if they have a condition requiring
- •systemic treatment with either corticosteroids (> 10 mg daily
- •prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab.
- •Patients should be excluded if they are positive test for hepatitis B
- •virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid
- •(HCV antibody) indicating acute or chronic infection
- •Patients should be excluded if they have known history of testing
- •positive for human immunodeficiency virus (HIV) or known acquired
- •immunodeficiency syndrome (AIDS)
- •Allergies and Adverse Drug Reaction
研究者
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