Multicenter, randomized, double-blind, phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed therapy in patients with stage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapy - BIBF plus Pemetrexed in 2nd line NSCLC patients

Boehringer Ingelheim0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 14

研究概览入排标准研究者记录与标识符相似试验

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 patient aged 18 years or older
•* Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or
•recurrent NSCLC (non squamous histologies)
•* Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus
•adjuvant therapy)
•* At least one target tumor lesion that has not been irradiated within the past three
•months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be
•recorded) as *20 mm with conventional techniques or as *10 mm with spiral CT
•* Life expectancy of at least three months
•* ECOG score of 0 or 1
•* Patient has given written informed consent which must be consistent with the
•International Conference on Harmonization * Good Clinical Practice (ICH-GCP) and
•local legislation

排除标准

•* More than one prior chemotherapy regimen for advanced, metastatic or recurrent
•* More than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) prior to first line chemotherapy of advanced, metastatic or recurrent NSCLC
•* Previous therapy with other vegfr inhibitors (other than bevacizumab) or pemetrexed for treatment of nsclc
•* Persistence of clinically relevant therapy related toxicities from previous
•chemotherapy and/or radiotherapy
•* Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
•* Chemo-, hormone-, immunotherapy therapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of brain and
•extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks
•* Radiotherapy (except extremities and brain) within the past three months prior to
•baseline imaging
•* Concomitant yellow fever vaccination
•* Patients taking NSAIDS with short half lives unable or unwilling to interrupt NSAIDs
•for a five day period (2 days before pemetrexed, day of pemetrexed, 2 days after
•pemetrexed)
•* Patients taking NSAIDS with long half lives must interrupt NSAID for 8 days (5 days
•before, day of and 2 days after treatment with pemetrexed)
•* Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants;
•dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
•* Leptomeningeal disease
•* Radiographic evidence of cavitary or necrotic tumors
•* Centrally located tumors with radiographic evidence (ct or mri) of local invasion of
•major blood vessels
•* History of clinically significant haemoptysis within the past 3 months (more than one teaspoon of fresh blood per day)
•* Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except
•for chronic low-dose therapy with acetylsalicylic acid *325mg per day)
•* History of major thrombotic or clinically relevant major bleeding event in the past
•* Known inherited predisposition to bleeding or thrombosis
•* Significant cardiovascular diseases (i.e., hypertension not controlled by medical
•therapy, unstable angina, history of myocardial infarction within the past 6 months,
•congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)
•* Calculated creatinine clearance by Cockcroft Gault <45ml/min
•* Proteinuria ctcae grade 2 or greater
•* Total bilirubin above the upper limit of normal
•* ALT and/or AST > 2.5 x upper limit of normal in the presence of live metastasis or
•ALT and/or AST >1.5 x upper limit of normal in patients without liver metastasis.
•* Prothrombin time and/or partial thromboplastin time greater than 50% deviation from normal limits
•* Absolute neutrophil count (ANC) <1500 neutrophils /mm3
•* Platelets <100,000 platelets/mm
•* Haemoglobin <9.0 g/dL
•* Significant weight loss (> 10 %) within the past 6 weeks prior to trea

研究者

发起方

Boehringer Ingelheim

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