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Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01966003
First Posted: October 21, 2013
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Actavis Inc.
Information provided by (Responsible Party):
Amgen
Results First Submitted: September 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer Metastatic
Interventions: Drug: Carboplatin
Drug: Paclitaxel
Drug: ABP 215
Drug: Bevacizumab

  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
This study was conducted at 101 sites (14 sites in the US, 11 in Russia, 10 in Australia, 9 in Germany, 8 in Poland, 7 in Hungary, 7 in Romania, 6 in Italy, 6 in Spain, 5 in Bulgaria, 5 in Greece, 3 in the Czech Republic, 3 in Mexico, 3 in Taiwan, 2 in the Netherlands, 1 in Canada, and 1 in Hong Kong).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants were randomized in a 1:1 ratio to receive ABP 215 or bevacizumab. Participants were stratified by geographic region (Eastern Europe vs Western Europe vs Asia Pacific/Other vs North America), Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1), and sex.

Reporting Groups
  Description
ABP 215 Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Bevacizumab Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.

Participant Flow:   Overall Study
    ABP 215   Bevacizumab
STARTED   328   314 
Received Study Drug   324   309 
COMPLETED   58   44 
NOT COMPLETED   270   270 
Death                43                36 
Protocol Violation                6                4 
Lost to Follow-up                4                3 
Physician Decision                12                13 
Withdrawal by Subject                29                19 
Plan to Receive Other Anticancer Therapy                131                127 
Plan to Receive Commercial Bevacizumab                44                67 
Other                1                1 



  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.
No text entered.

Reporting Groups
  Description
ABP 215 Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Bevacizumab Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Total Total of all reporting groups

Baseline Measures
   ABP 215   Bevacizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 328   314   642 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (9.09)   61.6  (8.88)   61.6  (8.98) 
Age, Customized 
[Units: Participants]
     
< 65 years   199   191   390 
≥ 65 years   129   123   252 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      132  40.2%      126  40.1%      258  40.2% 
Male      196  59.8%      188  59.9%      384  59.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      14   4.3%      16   5.1%      30   4.7% 
Not Hispanic or Latino      314  95.7%      298  94.9%      612  95.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
White   315   300   615 
Black or African American   2   5   7 
Asian   6   7   13 
American Indian or Alaska Native   2   0   2 
Native Hawaiian or other Pacific Islander   1   0   1 
Other   4   2   6 
[1] Participants were allowed to choose multiple races.
Geographic Region 
[Units: Participants]
     
Eastern Europe   189   186   375 
Western Europe   78   76   154 
North America   31   26   57 
Asia Pacific/Other   30   26   56 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
     
Grade 0   127   117   244 
Grade 1   201   197   398 
[1] A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With an Objective Response   [ Time Frame: Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]

2.  Secondary:   Duration of Response   [ Time Frame: Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]

3.  Secondary:   Progression-free Survival   [ Time Frame: From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]

4.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: up to 19 weeks ]

5.  Secondary:   Number of Participants Who Developed Anti-drug Antibodies   [ Time Frame: 44 weeks (6 months after end of treatment) ]

6.  Secondary:   Overall Survival   [ Time Frame: From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively. ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436



Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01966003     History of Changes
Other Study ID Numbers: 20120265
2013-000738-36 ( EudraCT Number )
First Submitted: October 4, 2013
First Posted: October 21, 2013
Results First Submitted: September 21, 2017
Results First Posted: October 19, 2017
Last Update Posted: October 19, 2017