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    Summary
    EudraCT Number:2016-003301-34
    Sponsor's Protocol Code Number:CBT124/CT/002
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-10-05
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2016-003301-34
    A.3Full title of the trial
    A Randomized, Double-blind, Multicentric, Parallel-group Study Comparing Efficacy, Safety and Immunogenicity of CBT124, a Candidate Biosimilar Bevacizumab in Combination with Carboplatin and Paclitaxel with EU sourced Avastin® in Combination with Carboplatin and Paclitaxel in First line Treatment for Subjects with Stage IV (Unresectable Recurrent Disease or Metastatic) Non-squamous Non-Small Cell Lung Cancer (NSCLC)
    Randomizált, kettős-vak, multicentrikus, párhuzamos csoportos klinikai vizsgálat a carboplatinnal és paclitaxellel kombinált CBT124 nevű bevacizumab-biohasonló jelölt készítmény, valamint a carboplatinnal és paclitaxellel kombinált EU-eredetű Avastin® hatékonyságának, biztonságosságának és immunogenitásának összehasonlítására IV-es stádiumú (inoperábilis recidív vagy áttétes folyamat) nem laphámsejtes, nem kissejtes tüdőrák (NSCLC) betegek első vonalbeli kezelésében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to determine whether CBT124 and Avastin®
    are comparable in terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that of Avastin®
    (pharmacokinetics is nested in this study for Indian patients).
    A.3.2Name or abbreviated title of the trial where available
    Efficacy, Safety & Immunogenicity Study of CBT124 & EU-sourced Avastin®
    A.4.1Sponsor's protocol code numberCBT124/CT/002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02879097
    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 SponsorCipla BioTec Pvt. Ltd.
    B.1.3.4CountryIndia
    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 supportCipla BioTec Pvt. Ltd.
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCipla BioTec Pvt. Ltd.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressL-174/B, Verna Industrial Estate
    B.5.3.2Town/ citySalcette, Verna, Goa
    B.5.3.3Post code403722
    B.5.3.4CountryIndia
    B.5.4Telephone number918328698082266
    B.5.6E-mailrenuka.joshi@ciplabiotec.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAvastin
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.3Other descriptive nameAvastin
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    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.3.2Product code CBT124
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeCBT124
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-squamous Non-Small-Cell-Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms of efficacy, safety, immunogenicity.
    E.2.2Secondary objectives of the trial
    Whether the pharmacokinetics of CBT124 matches that of Avastin® (pharmacokinetics is tested in this study for Indian patients).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult subjects aged ≥ 18 to 75 years (≥ 18 to 65 years for India) with histologically or cytologically confirmed advanced non-squamous NSCLC.
    •Epidermal growth factor receptor (EGFR) negative or wild type
    mutations
    •Stage IV (Unresectable recurrent disease or metastatic) NSCLC
    •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
    •Evaluable disease status or measurable tumor
    •Adequate hepatic, renal, and bone marrow function
    •Subjects with pre-existing hypertension must be well controlled on a stable regimen of antihypertensive therapy. Have systolic blood pressure ≤ 140 and ≥ 90 mmHg, diastolic blood pressure ≤ 90 and ≥ 50 mmHg and heart rate ≥ 40 and ≤ 90 bpm at screening and admission.
    •Ability to understand risks of participation in the study and willingness provide informed consent.
    E.4Principal exclusion criteria
    Small cell lung cancer (SCLC) or combination of SCLC and NSCLC.
    Squamous-cell tumors and mixed adenosquamous carcinomas of
    predominantly squamous nature
    •Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including bevacizumab
    •Prior therapy with carboplatin or paclitaxel
    •Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or radiotherapy for locally-advanced NSCLC if completed <12 months prior to screening
    •Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that in the opinion of the Investigator is likely to bleed
    •Symptomatic brain metastasis
    •Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
    •Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
    •History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. Thrombotic or hemorrhagic event ≤ 6 months prior to screening
    •History of hemoptysis greater than ½ teaspoon of bright red (fresh) blood in the past 4 weeks
    •Subjects receiving long-term aspirin (> 325 mg/day), or other nonsteroidal anti-inflammatory agents, or other drugs known to inhibit platelet function, treatment with dipyridamole, ticlopidine, or clopidogrel
    •Subjects receiving anticoagulants
    •Subjects who plan to undergo surgery during the study period
    •Subjects who have undergone a major surgery, or have had a
    significant traumatic injury within 4 weeks prior to randomization
    •Subjects who have a significant non-healing wound, or bone fracture within 4 weeks prior to randomization
    •Subjects with history of gastrointestinal perforation or fistula formation
    •Subjects with known hypersensitivity to any of the ingredients of the investigational products, or mammalian cell-derived products
    •Female subjects who are pregnant, breast-feeding, planning to be pregnant during the study, or women of child-bearing potential (any woman who is not surgically sterile i.e., bilateral tubal ligation, total hysterectomy or < 2 years post menopause) not using a reliable method of double contraception (e.g. condom plus diaphragm, condom or diaphragm plus spermicidal gel/foam, tubal ligation, or stable dose of hormonal contraception) throughout the study period
    •Male subject with a partner of childbearing potential who does not consent to the use of a reliable method of double contraception
    •Subjects with uncontrolled hypertension
    •Subjects with active infection assessed to be clinically significant by Investigator
    •Known history of, or positive test result for human immunodeficiency virus (HIV), hepatitis C virus (test for hepatitis C virus antibody [HCVAb]) or hepatitis B virus (test for Hepatitis B surface Antigen [HBsAg])
    •History of alcohol or substance abuse
    •Prior treatment with any investigational drug within the 30 days prior to screening, or within 5 half-lives of the drug, whichever is longer
    •Inability to comply with study requirements
    •Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    19 weeks
    E.5.2Secondary end point(s)
    Progression-free survival (PFS) rate at 1 year [ Time Frame: 1 year ] [Designated as safety issue: Yes ]
    Duration of response.
    •Overall Survival (OS) rate at 1 year [ Time Frame: 1 year ] [Designated as safety issue: Yes ]
    Duration of response.
    •Pharmacokinetics: Cmax and Ctrough [ Time Frame: Cycle 6 ] [Designated as safety issue: No]
    Cycle 1: Cmax; Cycle 2-6: Ctrough
    •Proportion of subjects with selected adverse events (AE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Proportion of subjects with selected adverse events (AE) of
    gastrointestinal perforation, hypertension, proteinuria, and pulmonary haemorrhage
    •Proportion of subjects with other selected AEs [ Time Frame: 1 year ] [Designated as safety issue: Yes ] Proportion of subjects with other selected AEs of hemorrhages, wound
    healing complications, abscess, and fistula formation
    •Proportion of subjects with other selected AEs/ SAEs/ Vital signs/Lab abnormalities [ Time Frame: 1 year ] [ Designated as safety issue: Yes] proportion of subjects with other selected AEs of Anaphylactic/hypersensitivity/ infusion-related reactions, arterial and venous thromboembolic events, and febrile neutropenia Incidence of AEs (overall), serious adverse events (SAEs), including changes in vital signs and laboratory abnormalities
    •Incidence of anti-drug (bevacizumab) antibody formation [ Time
    Frame: 1 year ] [ Designated as safety issue: Yes ]
    Incidence of anti-drug (bevacizumab) antibody formation, including incidence of neutralizing antibodies; Analysis of anti-drug antibody (ADA) positive and negative sub-population for PK, safety and efficacy.
    •Analysis of anti-drug antibody (ADA) positive and negative subpopulation for PK, safety and efficacy [ Time Frame: 1 year ] [
    Designated as safety issue: Yes ]
    Analysis of anti-drug antibody (ADA) positive and negative subpopulation for PK, safety and efficacy
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    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 No
    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 No
    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 No
    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) Yes
    E.8.2.2Placebo No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Bulgaria
    Hungary
    India
    South Africa
    Ukraine
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 200
    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)
    None
    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 Decision2016-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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