Multi-center, open, randomized (parallel) and comparative phase III. Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression. Arm A: Bevacizumab + pemetrexed Arm B: Bevacizumab + pemetrexed + carboplatin
Primary: * Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(\> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival Secondary: * To assess the efficacy of bevacizumab as measured by overall response rate and overall survival. * To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin. * To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13 * To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment * To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
271
Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks
Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Krankenhaus Martha-Maria Halle-Doelau
Halle, Germany
Progression Free Survival
Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).
Time frame: 42 months
Overall Survival
Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).
Time frame: 42 months
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