Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01966003 |
Recruitment Status :
Completed
First Posted : October 21, 2013
Results First Posted : October 19, 2017
Last Update Posted : October 19, 2017
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Sponsor:
Amgen
Collaborator:
Actavis Inc.
Information provided by (Responsible Party):
Amgen
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Study Type | Interventional |
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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 |
Enrollment | 642 |
Participant Flow
Recruitment Details | 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 | 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. |
Arm/Group Title | ABP 215 | Bevacizumab |
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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. | 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. |
Period Title: Overall Study | ||
Started | 328 | 314 |
Received Study Drug | 324 | 309 |
Completed | 58 | 44 |
Not Completed | 270 | 270 |
Reason Not Completed | ||
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
Arm/Group Title | ABP 215 | Bevacizumab | Total | |
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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. | 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 of all reporting groups | |
Overall Number of Baseline Participants | 328 | 314 | 642 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 328 participants | 314 participants | 642 participants | |
61.6 (9.09) | 61.6 (8.88) | 61.6 (8.98) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 328 participants | 314 participants | 642 participants |
< 65 years | 199 | 191 | 390 | |
≥ 65 years | 129 | 123 | 252 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 328 participants | 314 participants | 642 participants | |
Female |
132 40.2%
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126 40.1%
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258 40.2%
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Male |
196 59.8%
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188 59.9%
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384 59.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 328 participants | 314 participants | 642 participants | |
Hispanic or Latino |
14 4.3%
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16 5.1%
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30 4.7%
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Not Hispanic or Latino |
314 95.7%
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298 94.9%
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612 95.3%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 328 participants | 314 participants | 642 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]
Measure Description: Participants were allowed to choose multiple races.
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Geographic Region
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 328 participants | 314 participants | 642 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] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 328 participants | 314 participants | 642 participants |
Grade 0 | 127 | 117 | 244 | |
Grade 1 | 201 | 197 | 398 | |
[1]
Measure Description: 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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Amgen Inc. |
Phone: | 866-572-6436 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01966003 |
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 |