Clinical trial NCT01966003: Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer Metastatic
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Actavis Inc.
First posted: 2013-10-21
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Percentage of Participants With an Objective Response
timeFrame: 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 outcomes:
measure: Duration of Response
timeFrame: 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.
measure: Progression-free Survival
timeFrame: 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.
measure: Number of Participants With Adverse Events
timeFrame: up to 19 weeks
measure: Number of Participants Who Developed Anti-drug Antibodies
timeFrame: 44 weeks (6 months after end of treatment)
measure: Overall Survival
timeFrame: 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.
Other outcomes:
Locations:
city: Bismarck
country: United States
facility: Research Site
state: North Dakota
city: Fremantle
country: Australia
facility: Research Site
state: Western Australia
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
state: Veliko Turnovo
city: Ruse
country: Bulgaria
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.