Clinical Trials Register

Summary
EudraCT Number:	2013-000738-36
Sponsor's Protocol Code Number:	20120265
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-07-04
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2013-000738-36

A.3

Full title of the trial

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

Randomizované, dvojitě zaslepené klinické hodnocení fáze 3 hodnotící účinnost a bezpečnost přípravku ABP 215 v porovnání s bevacizumabem u pacientů s pokročilým nemalobuněčným karcinomem plic

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.3.2

Name or abbreviated title of the trial where available

Not Applicable

A.4.1

Sponsor's protocol code number

20120265

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Amgen Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Amgen Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Amgen (EUROPE) GmbH
B.5.2	Functional name of contact point	IHQ Medical Info-Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	Dammstrasse 23, PO Box 1557
B.5.3.2	Town/ city	Zug
B.5.3.3	Post code	CH-6300
B.5.3.4	Country	Switzerland
B.5.6	E-mail	Medinfointernational@amgen.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ABP 215
D.3.2	Product code	ABP 215
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	ABP 215
D.3.9.3	Other descriptive name	biosimilar product to bevacizumab
D.3.9.4	EV Substance Code	SUB74961
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Humanized immunoglobulin G1 (IgG1) monoclonal antibody manufactured in Chinese hamster ovary (CHO) cells
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Avastin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Avastin
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BEVACIZUMAB
D.3.9.1	CAS number	216974-75-3
D.3.9.4	EV Substance Code	SUB16402MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Humanized immunoglobulin G1 (IgG1) monoclonal antibody manufactured in Chinese hamster ovary (CHO) cells

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced Non-small Cell Lung Cancer

E.1.1.1

Medical condition in easily understood language

Advanced Non-small Cell Lung Cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the efficacy of ABP 215 with bevacizumab.

E.2.2

Secondary objectives of the trial

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

E.2.3

Trial contains a sub-study

E.3

Principal 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

E.4

Principal 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

E.5 End points

E.5.1

Primary end point(s)

Risk ratio of the incidence of overall response rate (ORR)

E.5.1.1

Timepoint(s) of evaluation of this end point

ORR is assessed every 6 weeks. The actual endpoint is best response seen during the study.

E.5.2

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)

E.5.2.1

Timepoint(s) of evaluation of this end point

Assessed at the end of the study

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

ADA - anti-drug antibody testing is being performed

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Completion of all study-related activities for all subjects (ie, 21 days after the last subject receives the last dose of investigational product)

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

299

F.4.2.2

In the whole clinical trial

620

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Standard of Care

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-09-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-07-23

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