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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CHU Rennes
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 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
- •?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 PD-L1 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 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),
- •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
- •History of
研究者
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