Conditions: Non-squamous Non-small Cell Lung Cancer
Keywords: lung cancer NSCLC elderly non-squamous Elderly patients at least 65 years old first line therapy non-squamous non-small cell lung cancer stage IIIb or IV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 271
Healthy volunteers: no

Brief summary:
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

Detailed description:
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

Arms:
arm 1: Bevacizumab + Pemetrexed arm 2: Bevacizumab + Pemetrexed + Carboplatin

Interventions: intervention 1: Bevacizumab + Pemetrexed intervention 2: Bevacizumab + Pemetrexed + Carboplatin
Intervention descriptions: intervention 1: 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 intervention 2: 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

Protocol document: