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
- Conditions
- Patients with advanced metastatic or recurrent non- small cell lung cancer (NSCLC).
- Registration Number
- EUCTR2008-002035-33-DE
- Lead Sponsor
- Martha-Maria Krankenhaus Halle-Dölau gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab by progression free survival;Secondary Objective: overall response rate and overall survival, safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin, quality of life, activity of daily life, comorbidity ;Primary end point(s): Objective Response ( tumour response according to RECIST)
- Secondary Outcome Measures
Name Time Method