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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2013-000738-36
Secondary ID [2] 0 0
20120265
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer Metastatic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an Objective Response
Timepoint [1] 0 0
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.
Secondary outcome [1] 0 0
Duration of Response
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Progression-free Survival
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Number of Participants With Adverse Events
Timepoint [3] 0 0
up to 19 weeks
Secondary outcome [4] 0 0
Number of Participants Who Developed Anti-drug Antibodies
Timepoint [4] 0 0
44 weeks (6 months after end of treatment)
Secondary outcome [5] 0 0
Overall Survival
Timepoint [5] 0 0
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.

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/07/2015
Sample size
Target
Accrual to date
Final
642
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Research Site - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Dakota
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Veliko Turnovo
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Ruse

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Actavis Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01966003
Trial related presentations / publications
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. Erratum In: Clin Cancer Res. 2019 May 15;25(10):3193. doi: 10.1158/1078-0432.CCR-19-1098.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01966003