The trial is designed to determine the efficacy and safety of ABP 215 compared with Bevacizumab in subjects with advanced non-small cell lung cancer

• Register: EUCTR
• Last refreshed on: 23 May 2016
• Main ID: EUCTR2013-000738-36-CZ
• Date of registration: 04/07/2013
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: The trial is designed to determine the efficacy and safety of ABP 215 compared with Bevacizumab in subjects 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 - Not Applicable
• Date of first enrolment: 26/09/2013
• Target sample size: 620
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000738-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, Czech Republic, Germany, Greece, Hong Kong, Hungary, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: IHQ Medical Info-Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info-Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Males and females = 18 and < 80 years of age

Histologically or cytologically confirmed non-squamous non-small cell lung cancer

Stage 4 or recurrent metastatic NSCLC with measurable disease according to modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1). For subjects with recurrent disease, at least 12 months must have elapsed since completing adjuvant chemotherapy. Subjects must have had a baseline scan (computed tomography [CT] or magnetic resonance imaging [MRI]) of the chest and abdomen to assess disease burden before enrolling in study and receiving first-line chemotherapy for NSCLC. If the scan was performed more than 28 days prior to randomization, an additional scan must be obtained

Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy

ECOG performance status score 0 or 1

Normal bone marrow function as defined by:
•absolute neutrophil count (ANC) = 1.5 x 109 g/dL (1,500/µL)
•platelets = 100 x 109 g/dL (100,000/µL)
•hemoglobin = 100 g/L (10.0 g/dL)

Adequate hepatic function as defined by:
•total bilirubin < 1.5 × the upper limit of normal (ULN)
•aspartate aminotransferase (AST) and alanine aminotransferase (ALT); < 3.0 × ULN;

Adequate renal function as defined by creatinine < 1.5 × ULN

Subjects must sign an IRB/EC-approved informed consent form before any study specific procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 435
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 185

Exclusion criteria:
Small cell lung cancer (SCLC) or mixed SCLC and NSCLC

Mixed adenosquamous carcinomas with a predominantly squamous component

Central nervous system (CNS) metastases

Tumor invading or compressing major blood vessels or tumor cavitation

Malignancy other than NSCLC

Palliative radiotherapy for bone lesions inside the thorax

Prior radiotherapy of bone marrow

Minor surgical procedure or core biopsy before randomization, or not yet recovered from prior minor surgery

Major surgery within 4 weeks before randomization or not yet recovered from prior surgery

Planned major surgical procedure during the treatment phase

Any of the following before randomization:
· clinically significant cardiovascular disease; peripheral vascular disease, cerebrovascular accident or transient ischemic attack
· history of hemoptysis
· history of thrombotic or hemorrhagic disorders

Proteinuria

Coagulation abnormalities or systemic anticoagulation or chronic aspirin therapy

Medically uncontrolled hypertension or systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg

Any unhealed wound or bone fracture

Clinically significant peripheral neuropathy

Significant weight loss

Any known co-morbid disease that would increase the risk of toxicity

Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

Recent infection requiring a course of systemic anti-infectives

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

Other investigational procedures while participating in this study

Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)

Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products

Subject has previously been randomized in this study

Subject likely to not be available to complete all protocol required study visits or procedures

History or evidence of any other clinically significant disorder, condition


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Advanced Non-small Cell Lung Cancer
MedDRA version: 17.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: ABP 215
Product Code: ABP 215
Pharmaceutical Form: Solution for infusion
Current Sponsor code: ABP 215
Other descriptive name: biosimilar product to bevacizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: Avastin
Product Name: Avastin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s): Risk ratio of the incidence of overall response rate (ORR)

Main Objective: To compare the efficacy of ABP 215 with bevacizumab.

Timepoint(s) of evaluation of this end point: ORR is assessed every 6 weeks. The actual endpoint is best response seen during the study.

Secondary Objective: To assess the safety and immunogenicity of ABP 215 compared with bevacizumab.

Secondary Outcome(s)

Secondary end point(s): Risk difference of the incidence of ORR
•Duration of response (DOR)
•Progression-free survival (PFS)
Safety Criteria:
•Treatment-emergent adverse events
•Treatment-emergent serious adverse events
•Incidence of anti-drug antibodies
•Overall survival (OS)

Timepoint(s) of evaluation of this end point: Assessed at the end of the study

Secondary ID(s)

20120265

2013-000738-36-HU

Source(s) of Monetary Support

Amgen Inc.