EUCTR2016-002071-96-GR进行中（未招募）1 期
A Single-Arm, Multicenter, Open-Label, Phase 2 Study of nab®-Paclitaxel (Abraxane®) and Carboplatin Chemotherapy plus Necitumumab (LY3012211) in theFirst-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Key Inclusion Criteria
- •- have given written informed consent or assent prior to any study-specific procedures. Written consent may also be given by a legal representative.
- •- have histologically or cytologically confirmed squamous NSCLC.
- •- have Stage IV disease at the time of study entry (American Joint Committee on Cancer [AJCC] Staging Manual, 7th edition [Edge et al. 2009]).
- •- have measurable disease at the time of study enrollment as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) (Eisenhauer et al. 2009).
- •- have tumor tissue (primary tumor or metastatic site; a paraffin-embedded tissue block [preferred] or 15 freshly cut unstained slides [a minimum of 6 slides] is requested) available for analysis of EGFR protein expression by immunohistochemistry (IHC).
- •- are =18 years of age (or of an acceptable age according to local regulations, whichever is older).
- •- have resolution to Grade =1 by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v 4.0), of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia).
- •- have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •- have an estimated life expectancy of at least 12 weeks.
- •- will be able to complete at least 2 cycles of treatment, in the judgment of the investigator.
- •- have adequate hepatic function as defined by a total bilirubin =1.25 × the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =5.0 × ULN in the presence of liver metastases or =2.5 × ULN in the absence of liver metastases.
- •- have adequate renal function as defined by serum creatinine =1.2 × ULN or calculated creatinine clearance (CrCl) =50 mL/min for patients with creatinine >1.2 x ULN.
- •- have adequate hematologic function as evidenced by white blood cell count =3.0 × 103/µL, absolute neutrophil count (ANC) =1.5 × 103/µL, hemoglobin =9.5 g/dL, and platelets =100 × 103/µL.
- •- are men who are either: (a) surgically sterile; or (b) agree to use a reliable method of birth control and to not donate sperm during the study and for at least 6 months following last dose of study drug(s) or per country requirements, whichever is longer.
- •- are women who are either: (a) not of childbearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause; or (b) of childbearing potential who have a negative serum pregnancy test within 14 days prior to first dose and agree to use a highly effective method of birth control during the study and for 6 months after the last dose of study drug(s) (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method).
- •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 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •Key Exclusion Criteria
- •- are currently enrolled in a clinical trial involving an investigational product (IP) or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •- have nonsquamous NSCLC (including adenocarcinoma, large cell, and not otherwise specified [NOS]).
- •- have received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
- •- have received previous chemotherapy for advanced NSCLC. Patients who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry.
- •- have undergone major surgery or received any investigational therapy in the 4 weeks prior to study entry.
- •- have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry.
- •- have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic for at least 30 days prior to study entry.
- •- have a history of arterial or venous embolism within 6 months prior to study entry.
- •- have current clinically relevant coronary artery disease (Canadian Cardiovascular Society Angina Grading Scale > class II) or congestive heart failure (New York Heart Association [NYHA] Congestive Heart Failure Classification class III or IV).
- •- have experienced myocardial infarction within 6 months prior to study entry.
- •- have clinical evidence of concomitant infectious conditions, including early signs of ongoing or active infection, tuberculosis, or known infection with the human immunodeficiency virus (HIV).
- •- have a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance.
- •- have any NCI-CTCAE v 4.0 Grade =2 peripheral neuropathy.
- •- have any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient’s ability to complete the study or sign an ICF.
- •- have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments.
- •- are pregnant or breastfeeding.
- •- have a known history of drug abuse.
- •- have a concurrent active malignancy. Patients with a history of malignancy are eligible provided the patient has been disease-free for =3 years, with the following exception: Patients with adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the judgment of the investigator and Lilly CRP/designee may not affect the interpretation of results (for example, prostate, bladder) are eligible.
- •- are receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent.
- •- are unwilling or unable to participate in, or do not have tissue adequate for participati
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