Patients with advanced metastatic or recurrent non- small cell lung cancer (NSCLC).
Conditions
Interventions
Trade Name: AVASTIN
Product Name: AVASTIN
Product Code: RO 487- 6646
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bevacizumab
Other descriptive name: IgG1 monoclonal Antibody
Concen
Sponsors
Martha-Maria Krankenhaus Halle-Dölau gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Outcome results
None listed