Open-label study of Bevacizumab (AVASTIN®) in combination with Pemetrexed or Pemetrexed and Carboplatin as first-line treatment of patients with advanced or recurrent non-squamous non-small cell lung cancer

Martha-Maria Krankenhaus Halle-Dölau gGmbH0 个研究点开始时间: 2008年10月7日最近更新: 2014年11月24日

适应症

试验速览

暂无简介。

•- Histologically or cytologically documented inoperable, locally advanced (stage IIIb
•with supraclavicular lymph node metastases or malignant pleural or pericardial
•effusion), metastatic (Stage IV) or recurrent NSCLC other than squamous cell
•(tumours of mixed histology should be categorized by the predominant cell type)
•- At least one measurable lesion according to RECIST criteria
•- Age = 65 years
•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

•- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas
•with a predominant squamous component
•- Patients who have had any prior platinum-based or other chemotherapy regimen
•for advanced disease. Prior chemotherapy given as neoadjuvant or adjuvant
•therapy for early stage disease, completed at least 6 months prior to diagnosis of
•advanced stage disease, will not be counted as a prior regimen.
•- History of haemoptysis, defined as bright red blood of at least half a teaspoon in
•the 3 months prior to enrolment
•- Evidence of tumour invading major blood vessels on imaging. The investigator or
•the local radiologist must exclude evidence of tumour that is fully contiguous with,
•surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary
•artery or superior vena cava)
•- Evidence of CNS metastases, even if previously treated. If suspected, the patient
•should be scanned within 28 days prior to enrolment to rule out CNS metastases
•- Radiotherapy within 28 days prior to enrolment

发起方

Martha-Maria Krankenhaus Halle-Dölau gGmbH