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    Summary
    EudraCT Number:2017-005175-78
    Sponsor's Protocol Code Number:SAMSON-II
    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:2019-05-21
    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 number2017-005175-78
    A.3Full title of the trial
    A Randomized, Double-blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in patients with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
    Randomizované, dvojito zaslepené, ekvivalenčné, multicentrické skúšanie III. fázy v paralelných skupinách na porovnanie účinnosti, bezpečnosti, farmakokinetiky a imunogenity HD204 oproti lieku Avastin® u pacientov s metastatickým alebo recidivujúcim neskvamocelulárnym nemalobunkovým karcinómom pľúc
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN EQUIVALENCE TRIAL TO COMPARE THE EFFICACY, SAFETY, PHARMACOKINETICS AND IMMUNOGENICITY OF HD204 TO AVASTIN® IN PATIENTS WITH LUNG CANCER.
    A.3.2Name or abbreviated title of the trial where available
    SAMSON-II
    A.4.1Sponsor's protocol code numberSAMSON-II
    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 SponsorPrestige BioPharma Limited
    B.1.3.4CountrySingapore
    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 supportPrestige BioPharma Limited
    B.4.2CountrySingapore
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrestige BioPharma Limited
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address2 Science Park Drive #04-13/14
    B.5.3.2Town/ citySingapore
    B.5.3.3Post code118222Singapore
    B.5.3.4CountrySingapore
    B.5.4Telephone number+6569246535
    B.5.5Fax number+6569242053
    B.5.6E-mailclinical.hd204@pbpsg.com
    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 namebevacizumab biosimilar
    D.3.2Product code HD204
    D.3.4Pharmaceutical form 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 Biosimilar
    D.3.9.2Current sponsor codeHD204
    D.3.9.3Other descriptive nameBEVACIZUMAB BIOSIMILAR
    D.3.9.4EV Substance CodeSUB179936
    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 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 25 mg/ml concentrate for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 nameEU-Avastin
    D.3.4Pharmaceutical form 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.3.9.4EV 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 (nsNSCLC)
    E.1.1.1Medical condition in easily understood language
    Non-squamous Non-small Cell Lung Cancer (nsNSCLC)
    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 demonstrate clinical equivalence of the bevacizumab biosimilar (HD204) to reference bevacizumab (EU-Avastin®) given with chemotherapy by comparing the best overall response rate (ORR) at Week 12 in Patients with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer.
    E.2.2Secondary objectives of the trial
    1. To compare ORR at Week 6 and Week 18 between the bevacizumab biosimilar (HD204) and reference bevacizumab (EU-Avastin®).
    2. To compare ORR at Week 12 adjusted on dose intensity.
    3. To compare the efficacy of bevacizumab biosimilar (HD204) to reference bevacizumab (EU-Avastin®) in terms of duration of response (DoR), progression-free survival (PFS) and overall survival (OS).
    4.To compare the safety and immunogenicity of bevacizumab biosimilar (HD204) and reference bevacizumab (EU-Avastin®).
    5. To compare bevacizumab PK parameters after administration of bevacizumab biosimilar (HD204) and reference bevacizumab (EU-Avastin®).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to give written informed consent.
    2. Aged ≥ 18 years of age.
    3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 and life expectancy >3 months based on Investigator’s judgement.
    4. Histologically confirmed metastatic Stage IV or recurrent non squamous non-small cell lung cancer (NSCLC) that is no longer amendable to curative surgery or local therapy.
    5. At least one measurable lesion according to RECIST v.1.1. as confirmed by CIR; bone-only and brain-only metastases are not allowed. Lesions previously treated with radiotherapy are non-target lesions unless clear progression was documented. Previous results are acceptable if performed within 4 weeks prior to screening.
    6. No first line treatment for metastatic or recurrent disease. Prior systemic therapy and/or radiotherapy for locally advanced disease is permitted if completed ≥ 6 months prior to the diagnosis of relapsing disease.
    7. Tumors without EGFR mutation or ALK receptor alteration. Patients with unknown mutation status or known EGFR mutation or ALK receptor alteration may be included provided the corresponding targeted agent is not available and chemotherapy is the standard of care of the study center.
    8. Adequate hematological function, defined as:
    a. Platelet count: ≥100,000/μL without the need for transfusion in the 2 weeks prior to Screening.
    b. Prothrombin time (PT), International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 x the upper limit of normal (ULN).
    c. Absolute neutrophil count: ≥1,500/μL without any medical interventionaltreatment (ie, granulocyte-colony stimulating factors [G-CSFs] and/or herbal remedies).
    d. Hemoglobin: ≥9 g/dL, without the need for transfusion in the 2 weeks prior to Screening.
    9. Adequate hepatic function as evidenced by meeting all of the following requirements:
    a. Total bilirubin: ≤ 1.5 x ULN.
    b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP): ≤ 3 x ULN.
    c. If liver metastases are present, ALT and AST ≤ 5 x ULN; if liver and/or bone metastases are present ALP ≤ 5 x ULN.
    10. Adequate renal function, as evidenced by meeting all of the following requirements:
    a. Serum creatinine ≤ 1.5 x ULN and creatinine clearance > 50 mL/minute or estimated glomerular filtration rate (GFR) >50 mL/minute.
    b. Urine dipstick for proteinuria of less than 2+ (other ways of urinalysis are also acceptable); if urine dip stick is ≥ 2+, proteinuria must be <2 g in 24 hours or an equivalent protein/creatinine ratio of <2000 mg/g creatinine (or < 226.0 mg/mmoL creatinine).
    11. Female patients with childbearing potential (excluding women who have undergone surgical sterilization or menopause. Menopause is defined as the status where no menstrual periods continue for 1 year or more without any other medical reasons), are eligible if they have negative serum pregnancy testing within 7 days
    prior to first dosing and are willing to use an effective method of birth
    control/contraception to prevent pregnancy until 6 months after the end of study. Male patients must consent using effective method of contraception until 6 months after the end of study.
    E.4Principal exclusion criteria
    1. Diagnosis of small cell carcinoma of the lung or mixed tumors
    including small cell
    carcinoma.
    2. Known ROS-1 positive tumor, except in scenarios where the
    corresponding target agent is not available, and chemotherapy is the
    standard of care at the study center. Patients with ROS-1 status not
    known at all can be considered as eligible for the study.
    3. Tumor cavitation, tumor invading into large blood vessels or close to
    large vessels with high risk of bleeding, according to Investigator's judgment.
    4. Prior therapy with monoclonal antibodies or small molecule inhibitors
    against VEGF
    or VEGFR.
    5. Prior systemic anticancer therapy, or radiotherapy for locally
    advanced nsNSCLC if
    completed < 6 months prior to the diagnosis of relapsing disease.
    6. Previous malignancy other than NSCLC in the last 5 years except for
    basal cell carcinoma
    of the skin or pre-invasive cancer of the cervix.
    7. Known brain metastasis or other CNS metastasis that is either
    symptomatic or
    untreated. Metastases that have been treated by complete resection
    and/or
    radiotherapy demonstrating stability or improvement are not an
    exclusion criterion
    provided they are stable as shown by computed tomography (CT) or
    magnetic
    resonance imaging (MRI) scan for at least 4 weeks before Screening
    without evidence
    of cerebral edema. Patients on stable dose of corticosteroids or
    anticonvulsants are
    permitted.
    8. Any unresolved toxicity > Grade I (except alopecia) from previous
    anticancer therapy
    (including radiotherapy).
    9. History of hemoptysis (> 1/2 teaspoon per event over the past 6
    months) or evidence
    of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
    Clinically
    non-significant minor bleeding is acceptable.
    10. A significant thrombotic or hemorrhagic event ≤ 6 months prior to
    Screening (includes
    hemoptysis [> 2.5 mL of red blood], gastrointestinal bleeding,
    hematemesis, CNS
    hemorrhage, severe epistaxis or vaginal bleeding, cerebral infarction,
    transient
    ischemic attacks, myocardial infarction, unstable angina, and
    uncontrolled coronary artery
    disease).
    11. Clinically serious non-healing wounds, or incompletely healed bone
    fracture at
    screening.
    12. Known hypersensitivity to any of the study drugs or their excipients,
    or history of
    clinically significant atopic allergy (eg, asthma including childhood
    asthma, urticarial).
    13. Live/attenuated vaccine within 12 weeks prior to the Screening Visit.
    14. History of myocardial infarction (≤ 6 months prior to Screening),
    unstable angina, New
    York Heart Association Grade II or greater, congestive heart failure, or
    serious cardiac
    arrhythmia requiring medication.
    15. History of poorly controlled hypertension or resting blood pressure
    >150/100 mmHg
    in the presence of a stable regimen of antihypertensive therapy.
    16. Any major surgical procedure (risk of bleeding or wound healing
    complications) within
    28 days prior to the screening.
    17. History of active gastroduodenal ulcer, abdominal fistula as well as
    nongastrointestinal
    fistula, gastrointestinal perforation or intra-abdominal abscess within
    6 months prior to Screening. However, patient with history of ulcer
    which had been treated could be considered as eligible for the study.
    18. Clinically significant active infection requiring systemic therapy.
    19. Known active Hepatitis B infection (according to local site standards)
    or active Hepatitis C infection (Hepatitis C virus [HCV] antibody
    positive); the patient could be included in the study if he/she is HCV RNA
    negative. Patient with unknown Hep B/C status, could be considered as
    eligible for the study.
    20. Known human immunodeficiency virus (HIV) infection (positive
    results from patient history are accepted), syphilis, or active
    tuberculosis infection. In cases where HIV/Syphilis/Tuberculosis status
    is not known at all, patient could be considered as eligible for the study.
    21. Patient considered unsuitable for inclusion by the Investigator (eg,
    inability to
    understand and/or comply with study requirements or presence of any
    condition,
    which, in the opinion of the Investigator, would not allow safe
    participation in the
    study).
    22. Pregnant or lactating women.
    23. Any planned dental surgical intervention during the study.
    24. Patients who require permanent oral anticoagulation (eg, warfarin,
    rivaroxaban, dabigatran, acenocumarol, etc.) treatment. However,
    administration of low molecular anticoagulants is permitted for
    prophylaxis purpose.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR12) at Week 12. The response is evaluated according to RECIST
    version 1.1, as assessed by the central, independent, blinded radiologist.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Efficacy:
    -ORR at Week 6 and Week 18 of the bevacizumab biosimilar (HD204)
    and reference
    bevacizumab (EU-Avastin®).
    - ORR at Week 12 adjusted on dose intensity.
    - Progression free Survival rate (PFS) at 12 months.
    - Progression free Survival time (time from randomization to date of
    documented clinical or
    radiological progression or death due to any cause).
    - Overall survival rate at 12 months.
    - Overall survival time.
    - Duration of Response (DOR) (from first documentation of a response
    (CP or PR) and first
    documentation of progression according to RECIST 1.1).
    Safety:
    Safety assessments will include monitoring for vital sign abnormalities,
    clinical laboratory
    abnormalities, physical examination, electrocardiogram parameters,
    adverse events (AEs; graded
    as mild, moderate, or severe), serious AEs, and treatment-emergent AEs
    (TEAEs).
    Immunogenicity:
    ADA and NADA correlated with Bevacizumab. Sampling: Baseline,end of cycle 4, end of Cycle 7 and at EoT
    Pharmacokinetics:
    Bevacizumab though following treatments of HD204 or EU-Avastin®.
    Sampling:
    -Baseline,
    -Cycle 2 (pre- and 1 hour post- infusion and 5-hour post-infusion);
    -Cycle 4 (pre- and 1 hour post- infusion and 5-hour post-infusion);
    -Cycle 6 (pre- and 1 hour post- infusion and 5-hour post-infusion);
    -EoT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: Week 6, 12 and 18. Month 12
    Immunogenicity: Baseline, end of cycle 4, end of Cycle 7, EoT
    Pharmacokinetics: Baseline, cycle 2, 4, 6 and EoT
    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 Yes
    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
    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 Yes
    E.8.1.7.1Other trial design description
    Equivalence
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Avastin
    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 concerned170
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Belarus
    Bulgaria
    Chile
    Croatia
    Georgia
    Greece
    Hungary
    India
    Latvia
    Malaysia
    Philippines
    Poland
    Russian Federation
    Serbia
    Slovakia
    Thailand
    Turkey
    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
    The study will be closed when all randomised and treated patients have
    completed their EoT visit, died, are lost to follow-up, have withdrawn
    consent, or 12 months have passed since randomization for patients
    who prematurely discontinued treatment, whichever occurs first for
    each individual patient.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 474
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 118
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 592
    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 completion of the study, i.e. after end of treatment (EoT),
    patients will be treated at the discretion of the investigator according
    to medical routine.
    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 Decision2019-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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