Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer (65plus)
|ClinicalTrials.gov Identifier: NCT00976456|
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Non-squamous Non-small Cell Lung Cancer||Drug: Bevacizumab + Pemetrexed Drug: Bevacizumab + Pemetrexed + Carboplatin||Phase 3|
- 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
- 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 (Clinical Trial)|
|Actual Enrollment :||271 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Active Comparator: Bevacizumab + Pemetrexed
Bevacizumab + Pemetrexed
Drug: 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
Active Comparator: Bevacizumab + Pemetrexed + Carboplatin
Bevacizumab + Pemetrexed + Carboplatin
Drug: 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
- Progression Free Survival [ Time Frame: 42 months ]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 [ Time Frame: 42 months ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976456
|Krankenhaus Martha-Maria Halle-Doelau|
|Halle, Germany, 06120|
|Study Chair:||Wolfgang Schuette, PhD MD.||Krankenhaus Martha-Maria Halle-Doelau|