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

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.
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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

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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. ]

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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. ]

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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. ]

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4. Secondary:

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

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5. Secondary:

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

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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. ]

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  Serious Adverse Events

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  Other Adverse Events

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  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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  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: 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. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: 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

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