NL-OMON34011尚未招募不适用
An open-label, phase Ib, dose-escalation trial on the safety, tolerability, pharmacokinetics, immunogenicity, biological effects and antitumor activity of EMD 521873 in combination with local irradiation (20 Gy) of primary tumors or metastases in subjects with non-small cell lung cancer stage IIIb with malignant pleural effusion or stage IV with disease control (partial response or stable disease) after application of 4 cycles of platinum-based, first-line chemotherapy. - EMD 521873 plus Radiotherapy in NSCLC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Merck KGaA
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female, aged >=18 years of age
- •Signed written informed consent
- •Effective contraception for male and female subjects of childbearing potential
- •ECOG performance status 0 or 1
- •Adequate hematological function defined by WBC >=3 x 109/L, neutrophils >=1.5 x 109/L, lymphocyte count >=0.5 x 109/L, platelet count >=100 x 109/L; hemoglobin >=9 g/L
- •Estimated creatinine clearance >=50 mL/min according to the Cockcroft - Gault formula or 24-h urine sampling
- •Adequate hepatic function defined by a total bilirubin level <=1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotrasferase (ALT) <=5 x ULN
排除标准
- •Requirement for immunosuppressive treatment with the exception of inhalative corticosteroids or low-dose systemic corticosteroids (prednisone equivalent dose <=10 mg/day)
- •Systemic autoimmune disease (e.g. lupus erythematodes, rheumatoid arthritis)
- •Organ transplant recipients
- •Active infections (including HIV, hepatitis B and C, tuberculosis)
- •Known or clinically suspected brain metastases
- •Active cardiovascular/cerebrovascular disease (e.g. symptomatic coronary vascular disease, congestive heart failure >= NYHA II, LVEF <50%, ventricular arrhythmia requiring medication, myocardial infarction or stroke) within previous 6 months
- •Pericardial effusion
- •Major impairment in pulmonary function: forced expiratory volume in 1 second (FEV1) <50% and diffusion capacity for carbon monoxide (DLCO) <50% of normal limit
- •Any other significant disease that in the Investigator*s opinion would exclude the subject from the trial
- •Known conditions associated with necroses of non-tumor bearing tissues (e.g. esophageal or gastroduodenal ulcers, ischemic bowel disease, chronic inflammations)
- •Pregnancy or lactation
- •Radiotherapy, chemotherapy, major surgery, biological therapy or any investigational drug within 30 days prior to the start of trial treatment
- •Requirement for concurrent systemic anticancer treatment (chemotherapy, biological therapy)
- •Pretreatment with anti-EGFR antibodies or tyrosine kinase inhibitors
- •Participation in another interventional clinical trial within the past 30 days before start of trial treatment
- •Known alcohol or drug abuse
- •Any psychiatric condition that would prohibit the understanding or rendering of the informed consent
- •Legal incapacity or limited legal capacity
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