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    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2018-004791-36
    A.3Full 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.3.1Title 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.3.2Name or abbreviated title of the trial where available
    DOMAJOR
    A.4.1Sponsor's protocol code numberBCD-100-3/DOMAJOR
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJSC BIOCAD
    B.1.3.4CountryRussian Federation
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJSC BIOCAD
    B.4.2CountryRussian Federation
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJSC BIOCAD
    B.5.2Functional name of contact pointClinical Trials Department
    B.5.3 Address:
    B.5.3.1Street AddressSvyazi str., 34-A, Strelna
    B.5.3.2Town/ citySaint Petersburg
    B.5.3.3Post code198515
    B.5.3.4CountryRussian Federation
    B.5.4Telephone number007812380 49 33
    B.5.5Fax number007812380 49 34
    B.5.6E-mailbiocad@biocad.ru
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBCD-100
    D.3.2Product code BCD-100
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROLGOLIMAB
    D.3.9.1CAS number 2093956-19-3
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB198018
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)
    Rozvinutá neskvamózna nemalobunková rakovina pľúc (NSCLC)
    E.1.1.1Medical condition in easily understood language
    lung cancer on late stages
    rakovina pľúc v pokročilom štádiu
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079440
    E.1.2Term Non-squamous non-small cell lung cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(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.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Imunogenicita
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If 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.8.7Trial 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.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 918
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In 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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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