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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 + Pemetrexed

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

Bevacizumab + Pemetrexed + Carboplatin

Wolfgang Schuette, PhD MD.

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

Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer

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

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).

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).

Roche Pharma AG

Eli Lilly and Company

PD Dr. med. Wolfgang Schuette

PhD MD

Bevacizumab + Pemetrexed

Bevacizumab + Pemetrexed: 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 + Pemetrexed + Carboplatin

Bevacizumab + Pemetrexed + Carboplatin: 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

Total

Age, Continuous

Sex: Female, Male

271 patients were enrolled and randomized, due to Screening failure and subject withdrawn consent the intent-to-treat (ITT) population comprised 253 evaluable patients (BP n=119; BPC n=134).

Prof. Dr. Wolfgang Schuette

Progression Free Survival

Overall Survival

Overall Study

Spots Global Cancer Trial Database for elderly patients at least 65 years old