Non-squamous Non-small Cell Lung Cancer Clinical Trial
Official title:
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
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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