Clinical Trials Register

Summary
EudraCT Number:	2018-004791-36
Sponsor's Protocol Code Number:	BCD-100-3/DOMAJOR
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-07-24
Trial 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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2018-004791-36

A.3

Full title of the trial

International Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial Evaluating Efficacy and Safety Of BCD-100 in combination with Pemetrexed+Cisplatin/Carboplatin Compared to Placebo in combination with Pemetrexed+Cisplatin/Carboplatin as First-Line Treatment of Subjects with Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

Medzinárodné, multicentrické, randomizované dvojito zaslepené placebom kontrolované klinické skúšanie na posúdenie účinnosti a bezpečnosti lieku BCD-100 v kombinácii s pemetrexed+cisplatina/karboplatina oproti placebu v kombinácii s pemetrexed+cisplatina/karboplatina ako prvej línie liečby u pacientov s pokročilým štádiom neskvamóznej nemalobunkovej rakoviny pľúc (NSCLC).

A.3.1

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

Hospitals from several countries,patients are allocated to two groups of treatment:one– investigational product+standard treatment,the other one – the medicine,which looks like the investigational product,but doesn’t contain the active substance+standard treatment.The allocation is done by chance, neither Investigator nor patient know to which group the patient has been allocated.The efficacy and safety of the investigational product will be evaluated.Participants' diagnose-Advanced Lung Cancer.

Nemocnice v rôznych krajinách, pacienti sú rozdelení do dvoch liečebných skupín: jedna- skúšaný liek + štandardná liečba, ďalšia- liek, ktorý vyzerá ako skúšaný liek, ale neobsahuje aktívnu zložku + štandardná liečba. Rozdelenie je náhodné, ani skúšajúci lekár ani pacient nevedeia, do ktorej skupiny bol pacient zaradený. Bude hodnotená účinnosť a bezpečnosť skúšaného lieku. Diagnóza účastníkov- pokročilá rakovina pľúc.

A.3.2

Name or abbreviated title of the trial where available

DOMAJOR

A.4.1

Sponsor's protocol code number

BCD-100-3/DOMAJOR

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	JSC BIOCAD
B.1.3.4	Country	Russian Federation
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	JSC BIOCAD
B.4.2	Country	Russian Federation
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	JSC BIOCAD
B.5.2	Functional name of contact point	Clinical Trials Department
B.5.3	Address:
B.5.3.1	Street Address	Svyazi str., 34-A, Strelna
B.5.3.2	Town/ city	Saint Petersburg
B.5.3.3	Post code	198515
B.5.3.4	Country	Russian Federation
B.5.4	Telephone number	007812380 49 33
B.5.5	Fax number	007812380 49 34
B.5.6	E-mail	biocad@biocad.ru

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	BCD-100
D.3.2	Product code	BCD-100
D.3.4	Pharmaceutical form	Concentrate for 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.3.8	INN - Proposed INN	PROLGOLIMAB
D.3.9.1	CAS number	2093956-19-3
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	N/A
D.3.9.4	EV Substance Code	SUB198018
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	20
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	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

Rozvinutá neskvamózna nemalobunková rakovina pľúc (NSCLC)

E.1.1.1

Medical condition in easily understood language

lung cancer on late stages

rakovina pľúc v pokročilom štádiu

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10079440
E.1.2	Term	Non-squamous non-small cell lung cancer
E.1.2	System Organ Class	100000004864

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 evaluate and compare efficacy of BCD-100 in combination with pemetrexed+cisplatin/carboplatin and Placebo in combination with pemetrexed+cisplatin/carboplatin as first-line treatment in subjects with metastatic NSCLC using OS

Zhodnotiť a porovnať účinnosť BCD-100 v kombinácii s pemetrexed+cisplatina/karboplatina a Placeba v kombinácii s pemetrexed+cisplatina/karboplatina ako prvej línie liečby u pacientov s metastatickou NSCLC s použitím OS

E.2.2

Secondary objectives of the trial

• To evaluate and compare efficacy of BCD-100 in combination with pemetrexed+cisplatin/carboplatin and Placebo in combination with pemetrexed+cisplatin/carboplatin as first-line treatment in subjects with metastatic NSCLC using ORR and PFS per RECIST 1.1 as assesses by BICR;
• To evaluate efficacy of BCD-100 in combination with pemetrexed+cisplatin/carboplatin versus Placebo in combination with pemetrexed+cisplatin/carboplatin according to PD-L1 expression status using OS, PFS, ORR, DCR
• To evaluate and compare the safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin and Placebo in combination with pemetrexed+cisplatin/carboplatin as first-line treatment in subjects with metastatic NSCLC

• Zhodnotiť a porovnať účinnosť BCD-100 v kombinácii s pemetrexed + cisplatina/karboplatina a Placeba v kombinácii s pemetrexed + cisplatina/karboplatina ako prvej línie liečby u pacientov s metastatickou NSCLC s použitím ORR a PFS na základe RECIST 1.1 podľa hodnotenia BICR;
• Zhodnotiť účinnosť BCD-100 v kombinácii s pemetrexed + cisplatina/karboplatina versus Placebo v kombinácii s pemetrexed + cisplatina/karboplatina podľa stavu expresie PD-L1 s použitím OS, PFS, ORR, DCR;
• Zhodnotiť a porovnať bezpečnosť BCD-100 v kombinácii s pemetrexed+ cisplatina/karboplatina a Placeba v kombinácii s pemetrexed+cisplatina/ karboplatina ako prvej línie liečby u pacientov s metastatickou NSCLC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

3. Previously untreated subjects with histologically-confirmed stage IV (M1a/M1b/M1c- AJCC 8th edition) non-squamous NSCLC;
5. The time from the completion of previous adjuvant/neoadjuvant treatment to metastatic disease development is no less than 12 months
6. Has a life expectancy of at least 12 weeks;
7. Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
9. Agreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (if obtaining of new sample is contraindicated or puts subject at unacceptable risks, then fresh archival tumor tissue sample must be available)
10. Measurable disease according to CT/MRI scan (RECIST 1.1 criteria), confirmed by the local assessment

3. Predtým neliečení pacienti s histologicky potvrdenou neskvamóznou NSCLC, štádium IV (M1a/M1b/M1c- AJCC 8. vydanie)
5. Čas od ukončenia predchádzajúcej adjuvantnej/neoadjuvantnej liečby do rozvoja metastatického ochorenia nie je kratší ako 12 mesiacov;
6. Predpokladaná dĺžka života aspoň 12 týždňov;
7. Má ECOG (Eastern Cooperative Oncology Group) Performance status 0 alebo 1;
9. Súhlas s novo získanou jadrovou alebo excíznou biopsiou nádorovej lézie, ktorá nebola predtým ožiarená na stanovenie statusu PD-L1 pred randomizáciou (ak je získanie novej vzorky kontraindikované alebo vystavuje subjekt neprijateľným rizikám, musí byť k dispozícii archívna vzorka nádorového tkaniva)
10. Merateľné ochorenie podľa CT skenovania (kritériá RECIST 1.1) potvrdené lokálnym posúdením;

E.4

Principal exclusion criteria

1. Has predominantly squamous cell histology NSCLC; Mixed tumours will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.
2. Presence of EGFR mutation or ALK rearrangement;
3. Has received prior systemic cytotoxic chemotherapy/chemoradiotherapy for metastatic disease;
4. Has received antineoplastic therapy with targeted or immunotherapeutic drugs (including but not limited to EGFR inhibitors [e.g., erlotinib, gefitinib, cetuximab], ALK inhibitors, PD-1/PD-L1/PD-L2/CTLA4, VEGF/VEGFR inhibitors) or it is expected to require any other form of antineoplastic therapy while on study;
11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
12. Active or known or suspected autoimmune disease (subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll).

1. Prevažne skvamózna bunková histológia NSCLC. Zmiešané nádory budú kategorizované prevládajúcim bunkovým typom; ak sú prítomné malé bunkové prvky, subjekt je nevhodný.
2. Prítomnosť EGFR mutácie alebo ALK translokácie;
3. Predchádzajúca systémová cytotoxická chemoterapia/chemoradiačná terapia pre metastatické ochorenie;
4. Predchádzajúca antineoplastická liečba s cielenými alebo imunoterapeutickými liekmi (vrátane, ale nie iba EGFR inhibítormi [napr. erlotinib, gefitinib, cetuximab], ALK inhibítormi, PD-1/PD-L1/PD-L2/CTLA4, VEGF/VEGFR inhibítory) alebo sa očakáva, že počas skúšania bude potrebná akákoľvek iná forma protinádorovej terapie;
11. Známe aktívne metastázy centrálneho nervového systému (CNS) a/alebo karcinomatóznu meningitídu;
12. Subjekty s aktívnym alebo známym alebo domnelým autoimunitným ochorením (diabetes mellitus typu 1, hypotyreózou vyžadujúcou iba hormonálnu náhradu, alebo s kožnými ochoreniami ( vitiligo, psoriáza alebo alopécia) nevyžadujúcimi systémovú liečbu), sa môžu zaradiť do skúšania.

E.5 End points

E.5.1

Primary end point(s)

overall survival (OS) - the time from the date of randomization until death due to any cause

Celkové prežitie (OS) - od začiatku randomizácie až po smrť v dôsledku akejkoľvek príčiny

E.5.1.1

Timepoint(s) of evaluation of this end point

OS will be assessed according to the data obtained at regular visits and during the follow-up by phone up to 3 years from the start of the therapy or until the end of the study

OS sa bude hodnotiť podľa údajov získaných pri pravidelných návštevách a počas sledovania telefonickými hovormi až do 3 rokov od začiatku liečby alebo do konca klinického skúšania.

E.5.2

Secondary end point(s)

• progression-free survival (PFS) per RECIST 1.1 criteria assessed by BICR - the time from the date of randomization until progression of disease according to RECIST 1.1 criteria or death,
• overall response rate (ORR) per RECIST 1.1 criteria assessed by BICR,
• disease control rate (DCR) per RECIST 1.1 criteria assessed by BICR,
• time to response (TTR),
• duration of response (DOR)

• Prežitie bez progresie (PFS) – podľa kritéria RECIST 1.1 stanoveného BICR - trvanie od randomizácie až po progresiu ochorenia alebo smrť,
• Celková miera odpovede (ORR) - podľa kritéria RECIST 1.1 stanoveného BICR,
• Miera kontroly ochorenia (DCR) - podľa kritéria RECIST 1.1 stanoveného BICR,
• Čas na odpoveď (TTR),
• Dĺžka trvania odpovede (DOR).

E.5.2.1

Timepoint(s) of evaluation of this end point

PFS, ORR, DCR, TTR, DOR will be assessed based on results of CT/MRI according to RECIST 1.1 criteria by blinded independent central review (BICR). Additional assessment of PFS and ORR will be performed according to iRECIST criteria. Contrast-enhanced CT/MRI will be performed on weeks 7, 13, 19, 25, 31, 40, 49, 61, 73, 97, 121, 145, additional CT/MRI scans can be performed within unscheduled visits.

PFS, ORR, DCR, TTR, DOR budú hodnotené na základe výsledkov CT/MRI podľa RECIST 1.1 kritérií zaslepeným, centrálnym, nezávislým hodnotením (BICR). Dodatočné hodnotenie PFS a ORR bude vykonané podľa kritéria iRECIST. CT/MRI s kontrastnou látkou bude vykonané v týždňoch 7, 13, 19, 25, 31, 40, 49, 61, 73, 97, 121, 145, dodatočné CT/MRI môžu byť vykonané v rámci neplánovaných návštev

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

Immunogenicity

Imunogenicita

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)

E.8.2.2

Placebo

Yes

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

China

Czechia

Hungary

Romania

Russian Federation

Slovakia

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

LVLS

PVPS

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 years

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:

190

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

918

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

106

F.4.2.2

In the whole clinical trial

292

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)

After the discontinuation of IMP, the participants will have access to other appropriate treatment, according to standard procedures.

Po ukončení liečby skúšaným liekom bude účastníkom zabezpečená vhodná liečba v súlade so štandardnými procedúrami.

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

2019-09-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-31

P. End of Trial
P.	End of Trial Status	Ongoing

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