Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
NCT ID: NCT01966003
Last Updated: 2017-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
642 participants
INTERVENTIONAL
2013-11-11
2015-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Carboplatin
Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W
Paclitaxel
Administered 200 mg/m² IV Q3W
ABP 215
Administered 15 mg/kg Q3W by IV infusion
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.
Carboplatin
Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W
Paclitaxel
Administered 200 mg/m² IV Q3W
Bevacizumab
Administered 15 mg/kg Q3W by IV infusion
Interventions
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Carboplatin
Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W
Paclitaxel
Administered 200 mg/m² IV Q3W
ABP 215
Administered 15 mg/kg Q3W by IV infusion
Bevacizumab
Administered 15 mg/kg Q3W by IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
Exclusion Criteria
* Central nervous system (CNS) metastases
* Malignancy other than NSCLC
* Palliative radiotherapy for bone lesions inside the thorax
* Prior radiotherapy of bone marrow
* Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Life expectancy \< 6 months
* Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
* Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
* Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
18 Years
80 Years
ALL
No
Sponsors
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Actavis Inc.
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Bismarck, North Dakota, United States
Research Site
Fremantle, Western Australia, Australia
Research Site
Veliko Tarnovo, Veliko Tarnovo, Bulgaria
Research Site
Rousse, , Bulgaria
Countries
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References
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Thatcher N, Goldschmidt JH, Thomas M, Schenker M, Pan Z, Paz-Ares Rodriguez L, Breder V, Ostoros G, Hanes V. Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer (MAPLE): A Randomized, Double-blind, Phase III Study. Clin Cancer Res. 2019 Apr 1;25(7):2088-2095. doi: 10.1158/1078-0432.CCR-18-2702. Epub 2019 Jan 7.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-000738-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120265
Identifier Type: -
Identifier Source: org_study_id