<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03296163</url>
  </required_header>
  <id_info>
    <org_study_id>MB02-C-02-17</org_study_id>
    <nct_id>NCT03296163</nct_id>
  </id_info>
  <brief_title>A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)</brief_title>
  <acronym>STELLA</acronym>
  <official_title>A Randomized, Multicenter, Multinational, Double-Blind Study to Assess the Efficacy and Safety of MB02 (Bevacizumab Biosimilar Drug) Versus Avastin® in Combination With Carboplatin and Paclitaxel for the Treatment of Subjects With Stage IIIB/IV Non-squamous Non-Small Cell Lung Cancer (NSCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>mAbxience Research S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>mAbxience Research S.L.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group,&#xD;
      equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy&#xD;
      (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel)&#xD;
      in subjects with Stage IIIB/IV non-squamous NSCLC&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Efficacy parameters, safety profiles and immunogenicity will be compared between MB02&#xD;
      (Bevacizumab Biosimilar Drug) and European (EU)-approved Avastin®&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2018</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">July 3, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR) at Week 18</measure>
    <time_frame>18 weeks from randomisation</time_frame>
    <description>Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC).&#xD;
Overall Response (OR) = CR + PR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>At Week 52 from randomisation</time_frame>
    <description>Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>At Week 52 from randomisation</time_frame>
    <description>Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>Week 1 to week 52</time_frame>
    <description>Comparison of Safety profile. Safety was monitored by incidence of adverse events (AEs). AEs were coded as per MedDRA (version 20.1) and severity was graded according to NCI-CTCAE (version 4.03);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb])</measure>
    <time_frame>At Weeks 1, 4, 10, 19, 34 and 52 from randomization and, at the End of Treatment Visit if, an ADA sample has not been collected within the previous 3 weeks</time_frame>
    <description>Incidence of anti-drug antibodies (ADA) and neutralizing ADAs (NAb). Analyses of ADA incidence rate, antibody titer, and neutralizing antibodies (NAb) (following the recommended 3-tier approach) were performed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">627</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>MB02 (Bevacizumab Biosimilar Drug)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EU-approved Avastin®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EU-approved Avastin® + Carboplatin/Paclitaxel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MB02 (Bevacizumab Biosimilar Drug)</intervention_name>
    <description>15 mg/kg IV every 3 weeks on Day 1</description>
    <arm_group_label>MB02 (Bevacizumab Biosimilar Drug)</arm_group_label>
    <other_name>Bevacizumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EU-approved Avastin®</intervention_name>
    <description>15 mg/kg IV every 3 weeks on Day 1</description>
    <arm_group_label>EU-approved Avastin®</arm_group_label>
    <other_name>Bevacizumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles</description>
    <arm_group_label>EU-approved Avastin®</arm_group_label>
    <arm_group_label>MB02 (Bevacizumab Biosimilar Drug)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
    <arm_group_label>EU-approved Avastin®</arm_group_label>
    <arm_group_label>MB02 (Bevacizumab Biosimilar Drug)</arm_group_label>
    <other_name>Taxol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and female subjects aged ≤ 18 years to ≤ 80 years.&#xD;
&#xD;
          2. Signed informed consent must be obtained before initiation of any study-specific&#xD;
             procedures or treatment as confirmation of the subject's awareness and willingness to&#xD;
             comply with the study requirements.&#xD;
&#xD;
          3. Subjects should have newly diagnosed or recurrent Stage IIIB/IV (defined by seventh&#xD;
             edition of the Tumor, Node and Metastasis (TNM) classification for Lung Cancer, 2010)&#xD;
             non-squamous NSCLC not amenable to curative intent surgery, and not have received any&#xD;
             systemic therapy for advanced disease (exclusion criteria 3 and 4). For subjects with&#xD;
             recurrent disease, at least 6 months must have elapsed before randomization from&#xD;
             previous adjuvant treatment.&#xD;
&#xD;
          4. Previous radiation therapy if completed &gt;4 weeks before randomization. Palliative&#xD;
             radiotherapy to bone lesions is allowed if completed &gt;2 weeks of randomization.&#xD;
&#xD;
          5. Subjects must have at least 1 unidimensional measurable lesion per RECIST version 1.1&#xD;
             (assessed locally).&#xD;
&#xD;
          6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤1&#xD;
             at Screening.&#xD;
&#xD;
          7. Subjects must have adequate hepatic, renal and hematologic function defined as:&#xD;
&#xD;
               -  Hepatic function: bilirubin level &lt;1.5 the upper limit of normal (ULN), alanine&#xD;
                  aminotransferase (ALT) and aspartate aminotransferase (AST) levels&lt;2.5×ULN.&#xD;
&#xD;
               -  Renal function: serum creatinine level &lt;1.5×ULN, calculated creatinine clearance&#xD;
                  (CrCl) &gt;50 mL/min (Cockcroft-Gault formula), urine protein to creatinine ratio&#xD;
                  &lt;1. Subjects with urine protein-to-creatinine ratio &gt;1 may be enrolled if they&#xD;
                  have &lt;1 g of protein in 24-hour urine collection.&#xD;
&#xD;
               -  Hematological function: Absolute neutrophil count &gt;1.5×109 /L; platelets &gt;100×109&#xD;
                  /L, hemoglobin (Hb) &gt;9 g/dL.&#xD;
&#xD;
               -  Adequate coagulation parameters such as: INR ≤ 2.0 and aPTT ≤ 1.5 x ULN within 7&#xD;
                  days prior to randomization for patients not receiving anticoagulation therapy.&#xD;
&#xD;
          8. Eligible subjects must have a systolic blood pressure of ≤ 140 mm Hg and a diastolic&#xD;
             blood pressure of ≤90 mm Hg at screening.&#xD;
&#xD;
          9. Women of childbearing potential, and their partners, must agree to adhere to pregnancy&#xD;
             prevention methods throughout the duration of the study (including the Follow-up&#xD;
             visits, where applicable). Women of childbearing potential are defined as those who&#xD;
             are not surgically sterile (did not underwent bilateral tubal ligation, bilateral&#xD;
             oophorectomy, or hysterectomy) and not postmenopausal.&#xD;
&#xD;
        Subjects and their partners must agree to use a highly effective method of contraception,&#xD;
        to avoid women becoming pregnant throughout the course of the study. Medically acceptable&#xD;
        forms of birth control can include the following, with approval of the treating physician:&#xD;
&#xD;
          -  Combined (estrogen and progestogen containing) hormonal contraception associated with&#xD;
             inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only&#xD;
             hormonal contraception associated with inhibition of ovulation (oral, injectable,&#xD;
             implantable), intrauterine device, intrauterine hormone-releasing system, bilateral&#xD;
             tubal occlusion, vasectomized partner, sexual abstinence.&#xD;
&#xD;
             10. Non fertile women can be included, that is, those who are physiologically&#xD;
             incapable of becoming pregnant, because of:&#xD;
&#xD;
          -  Hysterectomy.&#xD;
&#xD;
          -  Bilateral oophorectomy (ovariectomy).&#xD;
&#xD;
          -  Bilateral tubal ligation or,&#xD;
&#xD;
          -  Postmenopausal women defined as:&#xD;
&#xD;
        Subjects not using hormone replacement therapy (HRT) and have experienced total cessation&#xD;
        of menses for ≥ 1 year and be greater than 45 years of age, OR, in questionable cases, have&#xD;
        a follicle stimulating hormone &gt;40 mIU/mL and an estradiol value &lt;40 pg/mL (&lt;140 pmol/L).&#xD;
&#xD;
        Subjects must discontinue HRT before study enrolment because of the potential for&#xD;
        inhibition of cytochrome enzymes that metabolize estrogens and progestins. For most forms&#xD;
        of HRT, at least 2 to 4 weeks must elapse between the cessation of HRT and determination of&#xD;
        menopausal status; the length of this interval depends on the type and dosage of HRT.&#xD;
&#xD;
        If a female subject is determined not to be postmenopausal, that subject must use adequate&#xD;
        contraception, as defined immediately above (inclusion 8).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to comply with protocol procedures.&#xD;
&#xD;
          2. Participation in another clinical trial or treatment with another investigational&#xD;
             agent within 4 weeks or 5 half-lives of investigational agent before randomization,&#xD;
             whichever is longer.&#xD;
&#xD;
          3. Subjects previously treated with monoclonal antibodies or small molecule inhibitors&#xD;
             against Vascular Endothelial Growth Factor (VEGF) or VEGF receptors, including&#xD;
             Avastin®.&#xD;
&#xD;
          4. Subjects who have received previous chemotherapy, immunotherapy, targeted therapy, or&#xD;
             biological therapy for their lung cancer. Note: Adjuvant and neo- adjuvant therapy are&#xD;
             permitted (see: inclusion criterion 3).&#xD;
&#xD;
          5. Subjects who have known central nervous system disease, with the exception of subjects&#xD;
             with treated brain metastases who have completed treatment (radiation, surgery or&#xD;
             stereotactic surgery) and have not received steroids for at least 4 weeks before&#xD;
             randomization. Subjects with central nervous system metastases treated by&#xD;
             neurosurgical resection or brain biopsy performed within 8 weeks before randomization&#xD;
             will be excluded. Subjects with known or history of brain metastases must undergo&#xD;
             brain imaging during screening.&#xD;
&#xD;
          6. Current or recent (within 10 days of the first dose of study treatment) use of aspirin&#xD;
             (at least 325 mg/day) or other nonsteroidal anti-inflammatory drugs with antiplatelet&#xD;
             activity or treatment with dipyridamole (Persantine®), ticlopidine (Ticlid®),&#xD;
             clopidogrel (Plavix®), or cilostazol (Pletal®).&#xD;
&#xD;
          7. Current or recent (within 5 days) use of therapeutic anticoagulation or use of&#xD;
             thrombolytic agent. Prophylactic use of low molecular weight heparin is allowed.&#xD;
&#xD;
          8. Subjects with an INR &gt;2, unless receiving active anticoagulation treatment, will be&#xD;
             excluded.&#xD;
&#xD;
          9. Subjects who have a diagnosis of small cell carcinoma of the lung or squamous cell&#xD;
             carcinoma of the lung. Mixed tumors should be categorized according to the predominant&#xD;
             histology. If small cell elements are present, the subject will be excluded.&#xD;
&#xD;
         10. Subjects with known tumors that harbor activating epidermal growth factor receptor and&#xD;
             anaplastic lymphoma receptor tyrosine kinase (assessed locally).&#xD;
&#xD;
         11. Subjects who have a history of hypersensitivity to the active substance (bevacizumab,&#xD;
             carboplatin, and/or paclitaxel) or any of the excipients (such as trehalose dehydrate,&#xD;
             sodium phosphate, or polysorbate 20).&#xD;
&#xD;
         12. Subjects with known active viral infection, including but not limited to: hepatitis B,&#xD;
             hepatitis C, or HIV.&#xD;
&#xD;
         13. Subjects who are pregnant or breastfeeding. Women of child-bearing potential must have&#xD;
             a negative pregnancy test at Screening.&#xD;
&#xD;
         14. Subjects with previous major surgery, open biopsy, open pleurodesis, or significant&#xD;
             traumatic injury within 4 weeks before randomization or those anticipated to require&#xD;
             major surgery during the study.&#xD;
&#xD;
         15. Subjects who have had a core biopsy taken or have had another minor surgical&#xD;
             procedure, excluding placement of vascular access device, closed pleurodesis,&#xD;
             thoracentesis, and mediastinoscopy, within 1 week of randomization.&#xD;
&#xD;
         16. Subjects with a history of abdominal fistula, GI perforation, intra-abdominal abscess&#xD;
             within 6 months of randomization.&#xD;
&#xD;
         17. Subjects with a nonhealing wound, active ulcer, or untreated bone fracture.&#xD;
&#xD;
         18. Subjects with previous history of hypertensive crisis or hypertensive encephalopathy.&#xD;
&#xD;
         19. Subjects with New York Heart Association Grade II or greater congestive heart failure,&#xD;
             or angina, myocardial infarction within 6 months before randomization; symptomatic&#xD;
             arrhythmia or serious cardiac arrhythmia requiring medication; abnormal left&#xD;
             ventricular ejection fraction &lt; 50% assessed by ultrasound or multigated acquisition&#xD;
             scan.&#xD;
&#xD;
         20. Subjects with a previous malignancy within 3 years of randomization (other than&#xD;
             superficial basal cell and superficial squamous (skin) cell carcinoma, or carcinoma in&#xD;
             situ of the uterine cervix, bladder, or prostate).&#xD;
&#xD;
         21. Subjects with history of a significant vascular event within 6 months before&#xD;
             randomization (including, but not limited to myocardial infarction and stroke or&#xD;
             transient ischemic attack).&#xD;
&#xD;
         22. Subjects with known bleeding diathesis or significant coagulopathy defined as a&#xD;
             bleeding event grade ≥ 2 within 3 months before randomization.&#xD;
&#xD;
         23. Subjects with history of grade ≥2 hemoptysis within 6 months before randomization&#xD;
             (≥0.5 teaspoons of bright red blood per event).&#xD;
&#xD;
         24. Subjects with a tumor(s) invading or compressing major blood vessels.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>MedRadius</name>
      <address>
        <city>Maceió</city>
        <state>AL</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Câncer do Ceará - ICC</name>
      <address>
        <city>Fortaleza</city>
        <state>CE</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Brasileiro de Radioterapia Oncologia e Mastologia</name>
      <address>
        <city>Goiânia</city>
        <state>GO</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Erasto Gaertner - Paranaense de Combate ao Câncer</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cancer- INCA</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisa e Educação da Serra Gaúcha (CEPESG)</name>
      <address>
        <city>Caxias do Sul</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPCEM Universidade de Caxias Do Sul</name>
      <address>
        <city>Caxias do Sul</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Caridade de Ijuí</name>
      <address>
        <city>Ijuí</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Câncer - Hospital São Vicente de Paulo</name>
      <address>
        <city>Passo Fundo</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Lucas da PUCRS</name>
      <address>
        <city>Pôrto Alegre</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Câncer de Barretos</name>
      <address>
        <city>Barretos</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Base de São José do Rio Preto</name>
      <address>
        <city>São José do Rio Prêto</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisa do Instituto Brasileiro de Controle do Câncer - IBCC</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Ensino e Pesquisa São Lucas</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Marcelina</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Hospital Plovdiv</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acıbadem City Clinic Cancer Center UMHAT</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Hospital for Active Treatment of Oncology Diseases Sofia District EOOD</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Arturo López Pérez - Instituto Oncológico FALP</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health &amp; Care Spa</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Clinico Oncologico del Sur ICOS</name>
      <address>
        <city>Temuco</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncocentro APYS</name>
      <address>
        <city>Viña del Mar</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Adjara Autonomous Republic</name>
      <address>
        <city>Batumi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acad. F . Todua medical center-research institute of clinical medicine</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consilium Medulla</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Clinical Oncology</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD Aversi Clinic</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD Cancer Research Centre</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tbilisi State Medical Universitys First university Clinic</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Ippokratio&quot;</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sotiria General Hospital for Chest Diseases</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Larissa</name>
      <address>
        <city>Lárisa</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agioi Anargyroi General Oncological Hospital of Kifissia</name>
      <address>
        <city>Néa Kifisiá</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Thessaloniki &quot;George Papanikolaou&quot;</name>
      <address>
        <city>Thessaloníki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Koranyi Institute of TB and Pulmonology</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Országos Korányi Pulmonológiai Intézet (OKPI)</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza</name>
      <address>
        <city>Deszk</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veszprém Megyei Tüdőgyógyinzézet</name>
      <address>
        <city>Farkasgyepű</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház</name>
      <address>
        <city>Miskolc</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zydus Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Action Cancer Hospital</name>
      <address>
        <city>Delhi</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aadhar Health Institute</name>
      <address>
        <city>Hisar</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIMS - Nizam's Institute of Medical Sciences</name>
      <address>
        <city>Hyderabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganadhipati Purushottam Shekhawati Hospital Research Centre</name>
      <address>
        <city>Jaipur</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PVS Hospital Pvt Ltd</name>
      <address>
        <city>Kerola</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apollo Gleneagles Hospital</name>
      <address>
        <city>Kolkata</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Netaji Subhas Chandra Bose Cancer Research Institute</name>
      <address>
        <city>Kolkata</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shatabdi Super Speciality Hospital</name>
      <address>
        <city>Nashik</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deenanath Mangeshkar Hospital &amp; Research Center</name>
      <address>
        <city>Pune</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nirmal Hospital Pvt. Ltd.</name>
      <address>
        <city>Surat</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kiran Super Multispeciality Hospital</name>
      <address>
        <city>Sūrat</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shree Himalaya Cancer Hospital Research Institute</name>
      <address>
        <city>Vadodara</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's NRI Hospital Gurudwara Lane</name>
      <address>
        <city>Visakhapatnam</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Notre Dame de Secours</name>
      <address>
        <city>Jbaïl</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pulau Pinang</name>
      <address>
        <city>George Town</city>
        <state>Pulau Pinang</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Perubatan dan Pergigian Termaju Universiti Sains Malaysia</name>
      <address>
        <city>Kepala Batas</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Kuala Lumpur</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusat Perubatan Universiti Kebangsaan Malaysia</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Umum Sarawak</name>
      <address>
        <city>Kuching</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Putrajaya</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cancerologia</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Jose Eleuterio González</name>
      <address>
        <city>Monterrey</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sultan Qaboos University Hospital</name>
      <address>
        <city>Muscat</city>
        <country>Oman</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baguio General Hospital &amp; Medical Center</name>
      <address>
        <city>Baguio</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cebu Doctors University Hospital - CDUH</name>
      <address>
        <city>Cebu</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perpetual Succour Hospital - PSH</name>
      <address>
        <city>Cebu</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>De La Salle University Medical Center - DLSUMC</name>
      <address>
        <city>Dasmariñas</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Davao Doctors Hospital - DDH</name>
      <address>
        <city>Davao</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Makati Medical Center</name>
      <address>
        <city>Makati City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philippine General Hospital - PGH</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical City</name>
      <address>
        <city>Pasig</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center - Global City</name>
      <address>
        <city>Taguig</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary</name>
      <address>
        <city>Arkhangel'sk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional state budgetary Healthcare Institution &quot;Belgorod oncology dispensary&quot;</name>
      <address>
        <city>Belgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary</name>
      <address>
        <city>Ivanovo</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaluga Regional Clinical Oncology center</name>
      <address>
        <city>Kaluga</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republic Clinical Oncology Dispensary</name>
      <address>
        <city>Kazan'</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kursk Republican Clinical Oncology Dispensary</name>
      <address>
        <city>Kursk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;VitaMed&quot; LLC</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow City Oncology Hospital No 62</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N. N. Blokhin Russian Cancer Research Center</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Headache Clinic LLC</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal budget Healthcare Institution &quot;Volga District Medical Centre&quot; under Federal Medical and Biological Agency</name>
      <address>
        <city>Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GBUZ of SK Pyatigorsk Oncology Dispensary</name>
      <address>
        <city>Pyatigorsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Ryazan'</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Oncology Dispensary</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GUZ &quot;Leningrad Regional Clinical Hospital&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary healthcare Institution &quot;Samara regional clinical oncology dispensary&quot;</name>
      <address>
        <city>Samara</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHC Bezanijska Kosa</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Oncology and Radiology of Serbia (IORS)</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Kragujevac</name>
      <address>
        <city>Kragujevac</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical center Nis (Clinic for pulmonary diseases)</name>
      <address>
        <city>Niš</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Pulmonary Diseases of Vojvodina</name>
      <address>
        <city>Sremska Kamenica</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro Majadahonda</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bangkok International Hospital And Wattanosod Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiang Mai University (CMU) - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital</name>
      <address>
        <city>Chiang Mai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiang Rai Prachanukroh Hospital</name>
      <address>
        <city>Chiang Rai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Songklanagarind Hospital</name>
      <address>
        <city>Hat Yai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buddhachinaraj Hospital</name>
      <address>
        <city>Phitsanulok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Medeniyet University Medical Faculty</name>
      <address>
        <city>İstanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suat Seren Chest Diseases Hospital</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council</name>
      <address>
        <city>Cherkasy</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public Higher Education Insititution of Ukraine &quot;Bukovinian State Medical University&quot;</name>
      <address>
        <city>Chernivtsi</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multifield Clinical Hospital No.4</name>
      <address>
        <city>Dnepropetrovsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Oncology Dispensary</name>
      <address>
        <city>Dnipro</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution &quot;Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine&quot;</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution &quot;V.T. Zaycev Institute of general and urgent surgery of National academy medical sciences of Ukraine&quot;</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical and Diagnostic Centre Private Enterprise of Private Manufacturing Company &quot;ACINUS&quot;</name>
      <address>
        <city>Kropyvnytskyi</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution &quot;Kryviy Rih Oncology Dispensary&quot; of Dnipropetrovsk Regional Council</name>
      <address>
        <city>Kryvyi Rih</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Cancer</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv State Oncology Regional Treatment and Diagnostic Center</name>
      <address>
        <city>L'viv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare facility &quot;Volyn regional Oncological Dispensary&quot;</name>
      <address>
        <city>Luts'k</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odessa Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Odessa</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uzhgorod National University</name>
      <address>
        <city>Uzhgorod</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnytsia Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Vinnytsya</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution &quot;Zaporizhzhya Regional Clinical Oncological Dispensary&quot; of Zaporizhzhya regional council</name>
      <address>
        <city>Zaporizhzhya</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Chile</country>
    <country>Georgia</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Lebanon</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Oman</country>
    <country>Philippines</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Ukraine</country>
  </location_countries>
  <removed_countries>
    <country>Jordan</country>
    <country>Peru</country>
    <country>South Africa</country>
  </removed_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <results_first_submitted>February 22, 2021</results_first_submitted>
  <results_first_submitted_qc>March 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 26, 2021</results_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03296163/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03296163/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 627 subjects were randomized and assigned to one of the study arms. Two subjects in the MB02 arm failed screening but were randomized in error. These subjects did not receive treatment. Another two subjects did not receive MB02 treatment due to death (one subject) and unacceptable toxicity (one subject).&#xD;
Two subjects in the European (EU)-approved bevacizumab did not receive study treatment due to investigator decision (one subject) and unacceptable toxicity (one subject).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MB02 (Bevacizumab Biosimilar Drug)</title>
          <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel&#xD;
MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
        </group>
        <group group_id="P2">
          <title>EU-approved Avastin®</title>
          <description>EU-approved Avastin® + Carboplatin/Paclitaxel&#xD;
EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Combination Therapy</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="315"/>
                <participants group_id="P2" count="312"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="207"/>
                <participants group_id="P2" count="220"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Monotherapy</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="207"/>
                <participants group_id="P2" count="220"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
                <participants group_id="P2" count="146"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MB02 (Bevacizumab Biosimilar Drug)</title>
          <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel&#xD;
MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
        </group>
        <group group_id="B2">
          <title>EU-approved Avastin®</title>
          <description>EU-approved Avastin® + Carboplatin/Paclitaxel&#xD;
EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="315"/>
            <count group_id="B2" value="312"/>
            <count group_id="B3" value="627"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.0" lower_limit="54.0" upper_limit="67.0"/>
                    <measurement group_id="B2" value="61.0" lower_limit="56.0" upper_limit="67.5"/>
                    <measurement group_id="B3" value="61.0" lower_limit="55.0" upper_limit="67.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="244"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="193"/>
                    <measurement group_id="B2" value="190"/>
                    <measurement group_id="B3" value="383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="243"/>
                    <measurement group_id="B2" value="256"/>
                    <measurement group_id="B3" value="499"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body surface area (BSA)</title>
          <units>m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.780" lower_limit="1.600" upper_limit="1.940"/>
                    <measurement group_id="B2" value="1.790" lower_limit="1.595" upper_limit="1.940"/>
                    <measurement group_id="B3" value="1.780" lower_limit="1.600" upper_limit="1.940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR) at Week 18</title>
        <description>Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC).&#xD;
Overall Response (OR) = CR + PR.</description>
        <time_frame>18 weeks from randomisation</time_frame>
        <population>Primary efficacy analysis was done in the intention-to-treat (ITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>MB02 (Bevacizumab Biosimilar Drug)</title>
            <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel&#xD;
MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
          <group group_id="O2">
            <title>EU-approved Avastin®</title>
            <description>EU-approved Avastin® + Carboplatin/Paclitaxel&#xD;
EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) at Week 18</title>
          <description>Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC).&#xD;
Overall Response (OR) = CR + PR.</description>
          <population>Primary efficacy analysis was done in the intention-to-treat (ITT) population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" lower_limit="34.9" upper_limit="46.0"/>
                    <measurement group_id="O2" value="44.6" lower_limit="39.0" upper_limit="50.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence analysis was based on the risk ratio (RR) (MB02/EU-approved Avastin) with an equivalence margin predefined [0.73, 1.36].&#xD;
The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the RR and corresponding 2-sided 90% confidence interval (CI).</non_inferiority_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.910</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.780</ci_lower_limit>
            <ci_upper_limit>1.060</ci_upper_limit>
            <estimate_desc>Direction of comparison is: For RR: MB02/EU-approved Avastin. 95% CI was also calculated: (0.758, 1.092)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the risk difference (RD) (MB02-EU-approved Avastin) with an equivalence margin predefined [-12%, 12%] and corresponding 2-sided 95% CI.</non_inferiority_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-4.02</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.51</ci_lower_limit>
            <ci_upper_limit>2.47</ci_upper_limit>
            <estimate_desc>Direction of comparison is: For RD: MB02 - EU-approved Avastin. 95% CI was also calculated: (-11.76, 3.71)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS)</title>
        <description>Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event.</description>
        <time_frame>At Week 52 from randomisation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MB02 (Bevacizumab Biosimilar Drug)</title>
            <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel&#xD;
MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
          <group group_id="O2">
            <title>EU-approved Avastin®</title>
            <description>EU-approved Avastin® + Carboplatin/Paclitaxel&#xD;
EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS)</title>
          <description>Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event.</description>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0" lower_limit="33.0" upper_limit="36.43"/>
                    <measurement group_id="O2" value="37.3" lower_limit="36.14" upper_limit="45.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Hazard ratio of MB02 versus EU-approved Avastin; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; &gt;1 indicated an increase in PD/death in MB02; &lt;1 indicated an increase in PD/death in EU-approved Avastin.</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.187</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.</description>
        <time_frame>At Week 52 from randomisation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MB02 (Bevacizumab Biosimilar Drug)</title>
            <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel&#xD;
MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
          <group group_id="O2">
            <title>EU-approved Avastin®</title>
            <description>EU-approved Avastin® + Carboplatin/Paclitaxel&#xD;
EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.</description>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA: insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA: insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.108</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.827</ci_lower_limit>
            <ci_upper_limit>1.485</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Treatment-emergent Adverse Events (TEAEs)</title>
        <description>Comparison of Safety profile. Safety was monitored by incidence of adverse events (AEs). AEs were coded as per MedDRA (version 20.1) and severity was graded according to NCI-CTCAE (version 4.03);</description>
        <time_frame>Week 1 to week 52</time_frame>
        <population>Safety analyses were performed in the Safety population, which consisted of all subjects who received at least 1 administration of investigational medicinal product.</population>
        <group_list>
          <group group_id="O1">
            <title>MB02 (Bevacizumab Biosimilar Drug)</title>
            <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel&#xD;
MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
          <group group_id="O2">
            <title>EU-approved Avastin®</title>
            <description>EU-approved Avastin® + Carboplatin/Paclitaxel&#xD;
EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment-emergent Adverse Events (TEAEs)</title>
          <description>Comparison of Safety profile. Safety was monitored by incidence of adverse events (AEs). AEs were coded as per MedDRA (version 20.1) and severity was graded according to NCI-CTCAE (version 4.03);</description>
          <population>Safety analyses were performed in the Safety population, which consisted of all subjects who received at least 1 administration of investigational medicinal product.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>with ≥1 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="288"/>
                    <measurement group_id="O2" value="288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>with ≥1 Grade 3 or 4 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>with ≥1 treatment-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="264"/>
                    <measurement group_id="O2" value="270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>with ≥1 Grade 3 or 4 treatment-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>with at least one Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>with ≥1 TEAE leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>with ≥1 treatment-related TEAE leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb])</title>
        <description>Incidence of anti-drug antibodies (ADA) and neutralizing ADAs (NAb). Analyses of ADA incidence rate, antibody titer, and neutralizing antibodies (NAb) (following the recommended 3-tier approach) were performed.</description>
        <time_frame>At Weeks 1, 4, 10, 19, 34 and 52 from randomization and, at the End of Treatment Visit if, an ADA sample has not been collected within the previous 3 weeks</time_frame>
        <population>Immunogenicity was assessed in the Safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>MB02 (Bevacizumab Biosimilar Drug)</title>
            <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel&#xD;
MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
          <group group_id="O2">
            <title>EU-approved Avastin®</title>
            <description>EU-approved Avastin® + Carboplatin/Paclitaxel&#xD;
EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb])</title>
          <description>Incidence of anti-drug antibodies (ADA) and neutralizing ADAs (NAb). Analyses of ADA incidence rate, antibody titer, and neutralizing antibodies (NAb) (following the recommended 3-tier approach) were performed.</description>
          <population>Immunogenicity was assessed in the Safety population.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="311"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NAb positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NO seroconversion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239"/>
                    <measurement group_id="O2" value="247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the study completion. An average of two years (from the beginning of the study at 06-February-2018 till last patient last visit in 27-February-2020).</time_frame>
      <desc>Coded according to Medical Dictionary for Regulatory Activities (version 20.1), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 4.03). Table for &quot;Other Adverse events&quot; includes serious and non-serious events.&#xD;
Six (MB02: 4; EU-approved Avastin: 2) out of the 627 subjects randomized did not received treatment. Therefore, the &quot;total number of participants at risk&quot; comprised 621 subjects (MB02: 311 subjects; EU-approved Avastin:310).</desc>
      <group_list>
        <group group_id="E1">
          <title>MB02 (Bevacizumab Biosimilar Drug)</title>
          <description>MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel&#xD;
MB02 (Bevacizumab Biosimilar Drug): 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
        </group>
        <group group_id="E2">
          <title>EU-approved Avastin®</title>
          <description>EU-approved Avastin® + Carboplatin/Paclitaxel&#xD;
EU-approved Avastin®: 15 mg/kg IV every 3 weeks on Day 1&#xD;
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 6 cycles&#xD;
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Gastric ulcer perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hyperchlorhydria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Brain abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Ischemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cerebral ischemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Dysmetria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pulmonary hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="288" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="288" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="101" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="94" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="155" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="163" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="311"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Susana Millan</name_or_title>
      <organization>mAbxience Research SL</organization>
      <phone>+34917711500</phone>
      <email>susana.millan@mabxience.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296163
org study id: MB02-C-02-17
nct id: NCT03296163
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group,
      equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy
      (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel)
      in subjects with Stage IIIB/IV non-squamous NSCLC
Efficacy parameters, safety profiles and immunogenicity will be compared between MB02
      (Bevacizumab Biosimilar Drug) and European (EU)-approved Avastin®
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Objective Response Rate (ORR) at Week 18
time frame: 18 weeks from randomisation
description: Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC).
Overall Response (OR) = CR + PR.
measure: Progression-free Survival (PFS)
time frame: At Week 52 from randomisation
description: Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event.
measure: Overall Survival (OS)
time frame: At Week 52 from randomisation
description: Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.
measure: Incidence of Treatment-emergent Adverse Events (TEAEs)
time frame: Week 1 to week 52
description: Comparison of Safety profile. Safety was monitored by incidence of adverse events (AEs). AEs were coded as per MedDRA (version 20.1) and severity was graded according to NCI-CTCAE (version 4.03);
measure: Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb])
time frame: At Weeks 1, 4, 10, 19, 34 and 52 from randomization and, at the End of Treatment Visit if, an ADA sample has not been collected within the previous 3 weeks
description: Incidence of anti-drug antibodies (ADA) and neutralizing ADAs (NAb). Analyses of ADA incidence rate, antibody titer, and neutralizing antibodies (NAb) (following the recommended 3-tier approach) were performed.
arm group label: MB02 (Bevacizumab Biosimilar Drug)
arm group type: Experimental
description: MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel
arm group label: EU-approved Avastin®
arm group type: Active Comparator
description: EU-approved Avastin® + Carboplatin/Paclitaxel
intervention type: Drug
intervention name: MB02 (Bevacizumab Biosimilar Drug)
description: 15 mg/kg IV every 3 weeks on Day 1
arm group label: MB02 (Bevacizumab Biosimilar Drug)
other name: Bevacizumab
intervention type: Drug
intervention name: EU-approved Avastin®
description: 15 mg/kg IV every 3 weeks on Day 1
arm group label: EU-approved Avastin®
other name: Bevacizumab
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles
arm group label: EU-approved Avastin®
arm group label: MB02 (Bevacizumab Biosimilar Drug)
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles
arm group label: EU-approved Avastin®
arm group label: MB02 (Bevacizumab Biosimilar Drug)
other name: Taxol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
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country: Brazil
country: Bulgaria
country: Chile
country: Georgia
country: Greece
country: Hungary
country: India
country: Lebanon
country: Malaysia
country: Mexico
country: Oman
country: Philippines
country: Russian Federation
country: Serbia
country: Spain
country: Thailand
country: Turkey
country: Ukraine
country: Jordan
country: Peru
country: South Africa
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Bevacizumab
mesh term: Carboplatin
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