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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01966003
Registration number
NCT01966003
Ethics application status
Date submitted
4/10/2013
Date registered
21/10/2013
Date last updated
19/10/2017
Titles & IDs
Public title
Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
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Scientific title
A Randomized, Double-blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 215 Compared With Bevacizumab in Subjects With Advanced Non-Small Cell Lung Cancer
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Secondary ID [1]
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2013-000738-36
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Secondary ID [2]
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20120265
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer Metastatic
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - ABP 215
Treatment: Drugs - Bevacizumab
Experimental: 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.
Active Comparator: 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.
Treatment: Drugs: Carboplatin
Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W
Treatment: Drugs: Paclitaxel
Administered 200 mg/m² IV Q3W
Treatment: Drugs: ABP 215
Administered 15 mg/kg Q3W by IV infusion
Treatment: Drugs: Bevacizumab
Administered 15 mg/kg Q3W by IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With an Objective Response
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Assessment method [1]
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Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders.
CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to < 10 mm.
PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions.
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Timepoint [1]
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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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Secondary outcome [1]
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Duration of Response
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Assessment method [1]
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Duration of response (DOR) was calculated as the time from the first objective response (PR or CR) to disease progression per RECIST v1.1 based on the central, independent, blinded radiologists' review.
DOR was only calculated for participants with an objective response. For responders not meeting the criterion for progression by the end of the study, DOR was censored at the date of the last evaluable tumor assessment.
Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions.
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Timepoint [1]
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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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Secondary outcome [2]
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Progression-free Survival
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Assessment method [2]
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Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression using RECIST v1.1 based on the central, independent, blinded radiologists' review, or death. Participants who were alive and did not meet the criteria for progression by the end of the study were censored at their last evaluable disease assessment date. Participants with no evaluable tumor assessments after randomization who did not die by the end of the study were censored on the randomization date.
Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions.
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Timepoint [2]
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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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Secondary outcome [3]
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Number of Participants With Adverse Events
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Assessment method [3]
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Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4, and according to the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death due to AE.
A serious adverse event (SAE) is defined as an AE that meets at least 1 of the following serious criteria:
fatal
life-threatening
required inpatient hospitalization or prolongation of existing hospitalization
resulted in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event
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Timepoint [3]
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up to 19 weeks
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Secondary outcome [4]
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Number of Participants Who Developed Anti-drug Antibodies
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Assessment method [4]
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Two validated assays were used to detect the presence of anti-ABP 215 antibodies. Samples were first tested in an electrochemiluminescence (ECL)- based bridging immunoassay to detect antibodies capable of binding to ABP 215 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based target binding assay to determine neutralizing activity against ABP 215 (Neutralizing Antibody Assay). If a post-dose sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
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Timepoint [4]
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44 weeks (6 months after end of treatment)
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Secondary outcome [5]
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Overall Survival
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Assessment method [5]
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Overall survival (OS) was defined as the time from the randomization date to date of death. Participants alive at the end of study were censored at the last date known to be alive, derived from dates collected within the study that implied a participant was alive.
Participants were followed for survival status during the treatment phase and thereafter every 9 weeks until the end of the clinical study, consent was withdrawn, they were lost to follow-up, died, or had proscribed therapy (eg, commercial bevacizumab, non-study anti-cancer treatment).
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Timepoint [5]
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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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Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer
(NSCLC)
- 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Small cell lung cancer (SCLC) or mixed SCLC and NSCLC
- 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
- Other inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/07/2015
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Sample size
Target
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Accrual to date
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Final
642
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Research Site - Fremantle
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Recruitment postcode(s) [1]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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North Dakota
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Country [2]
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Bulgaria
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State/province [2]
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Veliko Turnovo
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Country [3]
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Bulgaria
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State/province [3]
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Ruse
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Actavis Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this research study is to compare the effectiveness and safety of ABP 215
against bevacizumab in men and women with advanced non-small cell lung cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01966003
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01966003
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