EUCTR2010-019707-32-GB进行中（未招募）1 期
ME-Lung 3. A Phase I/II study of continuous oral treatment with BIBF 1120 added to standard gemcitabine/cisplatin therapy in first line NSCLC patients with squamous cell histology. - LUME-Lung 3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
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
入选标准
- •Run-in Phase I
- •1.Histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent NSCLC with squamous cell histology.
- •2.Measurable disease according to RECIST 1.1.
- •3.Patient Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- •4.Male or female patients age = 18 years.
- •5.Life expectancy of at least three (3) months.
- •6.Written informed consent in accordance with ICH-GCP guidelines.
- •In addition to the above inclusion criteria:
- •7.Radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin / gemcitabine chemotherapy.
- •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
- •1.Prior therapy for advanced or metastatic or recurrent NSCLC. One prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
- •2.Prior treatment with other VEGFR inhibitors (other than bevacizumab)
- •3.Known pre-existing interstitial lung disease e.g. caused by asbestosis
- •4.Significant weight loss (>10%) within 6 weeks prior to starting treatment in the 1199.82 study.
- •5.Any contraindications for treatment with gemcitabine and/or cisplatin.
- •6.Ototoxicity and symptomatic neuropathy > Grade 1 according to the NCI CTCAE
- •7.Use of any investigational drug within 4 weeks of entering the 1199.82 study.
- •8.History of clinically significant haemoptysis within the past 3 months (more than one tea spoon of fresh blood per day).
- •9.Therapeutic anticoagulation (except for prophylactic low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or anti-platelet therapy (except for chronic low-dose therapy with acetylsalicylic acid = 325mg per day).
- •10.History of major thrombotic or clinically relevant bleeding event in the past 6
- •11.Known inherited predisposition to bleeding or thrombosis.
- •12.Significant cardiovascular diseases (i.e. hypertension not controlled by medication,
- •unstable angina, history of myocardial infarction) within the past 6 months,
- •congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion).
- •13.Surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
- •14.Active brain metastases (eg stable for <4 weeks, no adequate previous treatment
- •with radiotherapy, symptomatic, requiring treatment with anti-convulsants;
- •dexamethasone therapy will be allowed if administered as a stable dose for at least
- •one month before inclusion into the study.)
- •15.Leptomeningeal disease.
- •16.Radiographic evidence of cavitary or necrotic tumours.
- •17.Centrally located tumours with radiographic evidence (on CT or MRI) of local
- •invasion of major blood vessels.
- •18.Radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
- •19.Any other current malignancy or malignancy diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer).
- •20.Gastrointestinal disorders or abnormalities that would interfere with the absorption of the study drug.
- •21.Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
- •22.Presence of clinically significant third-space fluid collections (for example ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior tostudy entry.
- •23.Prothrombin time and / or partial thromboplastin time greater than 50% deviation
研究者
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