A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00130728
First received: August 12, 2005
Last updated: September 26, 2011
Last verified: September 2011
Results First Received: November 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: bevacizumab
Drug: erlotinib HCl
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Participant Flow:   Overall Study
    Erlotinib HCl + Bevacizumab     Erlotinib HCl + Placebo  
STARTED     319     317  
Received Study Drug (Safety Population)     313     313  
COMPLETED     108     104  
NOT COMPLETED     211     213  
Death                 207                 211  
Lost to Follow-up                 4                 0  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
Total Total of all reporting groups

Baseline Measures
    Erlotinib HCl + Bevacizumab     Erlotinib HCl + Placebo     Total  
Number of Participants  
[units: participants]
  319     317     636  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 10.4     65.0  ± 10.3     64.9  ± 10.4  
Age, Customized  
[units: participants]
     
Between 18 and 59 years     91     90     181  
Between 60 and 64 years     62     66     128  
Between 65 and 69 years     59     53     112  
>= 70 years     107     108     215  
Gender  
[units: participants]
     
Female     148     147     295  
Male     171     170     341  



  Outcome Measures
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1.  Primary:   Overall Survival (OS) Among All Randomized Patients   [ Time Frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years) ]

3.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: The median duration of Objective response was up to 9.7 months ]

4.  Secondary:   Duration of Objective Response   [ Time Frame: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months) ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Up to 3 years
Additional Description Safety Evaluable Population

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Other Adverse Events
    Erlotinib HCl + Bevacizumab     Erlotinib HCl + Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     310/313     306/313  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     19/313 (6.07%)     29/313 (9.27%)  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     203/313 (64.86%)     162/313 (51.76%)  
Nausea † 1    
# participants affected / at risk     121/313 (38.66%)     99/313 (31.63%)  
Vomiting † 1    
# participants affected / at risk     57/313 (18.21%)     49/313 (15.65%)  
Constipation † 1    
# participants affected / at risk     49/313 (15.65%)     45/313 (14.38%)  
Stomatitis † 1    
# participants affected / at risk     40/313 (12.78%)     27/313 (8.63%)  
Abdominal Pain † 1    
# participants affected / at risk     29/313 (9.27%)     25/313 (7.99%)  
Dyspepsia † 1    
# participants affected / at risk     21/313 (6.71%)     16/313 (5.11%)  
Dysphagia † 1    
# participants affected / at risk     19/313 (6.07%)     12/313 (3.83%)  
Gastrooesophageal Reflux Disease † 1    
# participants affected / at risk     18/313 (5.75%)     10/313 (3.19%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     146/313 (46.65%)     124/313 (39.62%)  
Pyrexia † 1    
# participants affected / at risk     33/313 (10.54%)     23/313 (7.35%)  
Asthenia † 1    
# participants affected / at risk     34/313 (10.86%)     20/313 (6.39%)  
Chest Pain † 1    
# participants affected / at risk     27/313 (8.63%)     24/313 (7.67%)  
Oedema Peripheral † 1    
# participants affected / at risk     18/313 (5.75%)     32/313 (10.22%)  
Mucosal Inflammation † 1    
# participants affected / at risk     35/313 (11.18%)     16/313 (5.11%)  
Pain † 1    
# participants affected / at risk     15/313 (4.79%)     18/313 (5.75%)  
Chills † 1    
# participants affected / at risk     23/313 (7.35%)     11/313 (3.51%)  
Infections and infestations      
Urinary Tract Infection † 1    
# participants affected / at risk     33/313 (10.54%)     26/313 (8.31%)  
Upper Respiratory Tract Infection † 1    
# participants affected / at risk     30/313 (9.58%)     30/313 (9.58%)  
Pneumonia † 1    
# participants affected / at risk     9/313 (2.88%)     16/313 (5.11%)  
Bronchitis † 1    
# participants affected / at risk     10/313 (3.19%)     18/313 (5.75%)  
Sinusitis † 1    
# participants affected / at risk     16/313 (5.11%)     8/313 (2.56%)  
Investigations      
Weight Decreased † 1    
# participants affected / at risk     65/313 (20.77%)     41/313 (13.10%)  
Metabolism and nutrition disorders      
Anorexia † 1    
# participants affected / at risk     104/313 (33.23%)     75/313 (23.96%)  
Dehydration † 1    
# participants affected / at risk     35/313 (11.18%)     24/313 (7.67%)  
Decreased Appetite † 1    
# participants affected / at risk     36/313 (11.50%)     21/313 (6.71%)  
Hypokalaemia † 1    
# participants affected / at risk     17/313 (5.43%)     21/313 (6.71%)  
Musculoskeletal and connective tissue disorders      
Back Pain † 1    
# participants affected / at risk     46/313 (14.70%)     41/313 (13.10%)  
Arthralgia † 1    
# participants affected / at risk     37/313 (11.82%)     27/313 (8.63%)  
Musculoskeletal Pain † 1    
# participants affected / at risk     34/313 (10.86%)     23/313 (7.35%)  
Pain in Extremity † 1    
# participants affected / at risk     24/313 (7.67%)     20/313 (6.39%)  
Musculoskeletal Chest Pain † 1    
# participants affected / at risk     19/313 (6.07%)     15/313 (4.79%)  
Muscle Spasms † 1    
# participants affected / at risk     16/313 (5.11%)     17/313 (5.43%)  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     53/313 (16.93%)     28/313 (8.95%)  
Dizziness † 1    
# participants affected / at risk     41/313 (13.10%)     31/313 (9.90%)  
Dysgeusia † 1    
# participants affected / at risk     29/313 (9.27%)     19/313 (6.07%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     38/313 (12.14%)     25/313 (7.99%)  
Anxiety † 1    
# participants affected / at risk     26/313 (8.31%)     30/313 (9.58%)  
Depression † 1    
# participants affected / at risk     31/313 (9.90%)     19/313 (6.07%)  
Renal and urinary disorders      
Proteinuria † 1    
# participants affected / at risk     18/313 (5.75%)     8/313 (2.56%)  
Dysuria † 1    
# participants affected / at risk     16/313 (5.11%)     6/313 (1.92%)  
Respiratory, thoracic and mediastinal disorders      
Cough † 1    
# participants affected / at risk     73/313 (23.32%)     76/313 (24.28%)  
Dyspnoea † 1    
# participants affected / at risk     61/313 (19.49%)     64/313 (20.45%)  
Epistaxis † 1    
# participants affected / at risk     63/313 (20.13%)     30/313 (9.58%)  
Pharyngolaryngeal Pain † 1    
# participants affected / at risk     27/313 (8.63%)     14/313 (4.47%)  
Dysphonia † 1    
# participants affected / at risk     33/313 (10.54%)     6/313 (1.92%)  
Haemoptysis † 1    
# participants affected / at risk     22/313 (7.03%)     14/313 (4.47%)  
Wheezing † 1    
# participants affected / at risk     17/313 (5.43%)     9/313 (2.88%)  
Dyspnoea Exertional † 1    
# participants affected / at risk     6/313 (1.92%)     17/313 (5.43%)  
Rhinorrhoea † 1    
# participants affected / at risk     16/313 (5.11%)     6/313 (1.92%)  
Skin and subcutaneous tissue disorders      
Rash † 1    
# participants affected / at risk     193/313 (61.66%)     184/313 (58.79%)  
Dry Skin † 1    
# participants affected / at risk     63/313 (20.13%)     58/313 (18.53%)  
Dermatitis Acneiform † 1    
# participants affected / at risk     58/313 (18.53%)     42/313 (13.42%)  
Pruritus † 1    
# participants affected / at risk     47/313 (15.02%)     40/313 (12.78%)  
Alopecia † 1    
# participants affected / at risk     18/313 (5.75%)     16/313 (5.11%)  
Erythema † 1    
# participants affected / at risk     16/313 (5.11%)     11/313 (3.51%)  
Skin Exfoliation † 1    
# participants affected / at risk     8/313 (2.56%)     16/313 (5.11%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     77/313 (24.60%)     26/313 (8.31%)  
Events were collected by systematic assessment
1 Term from vocabulary, MeDRA



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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