A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
|ClinicalTrials.gov Identifier: NCT00451906|
Recruitment Status : Completed
First Posted : March 26, 2007
Results First Posted : April 25, 2016
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Squamous Non-Small Cell Lung Cancer||Drug: Platinum-based chemotherapy Drug: Bevacizumab [Avastin]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2252 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Bevacizumab + Chemotherapy
Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
Drug: Platinum-based chemotherapy
As prescribedDrug: Bevacizumab [Avastin]
15 mg/kg IV on Day 1 of each 3 week cycle
- Number of Participants With Adverse Events of Special Interest [ Time Frame: Up to 3 years ]Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.
- Number of Participants With Serious Adverse Events Related to Bevacizumab [ Time Frame: Up to 3 years ]Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.
- Duration of Overall Survival [ Time Frame: Up to 3 years ]Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.
- Time to Disease Progression [ Time Frame: Up to 3 years ]Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
- Number of Participants With Central Nervous System Bleeding [ Time Frame: Up to 3 years ]The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451906
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|Study Director:||Clinical Trials||Hoffmann-La Roche|