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

Study Description

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

Keywords

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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