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    Summary
    EudraCT Number:2018-000245-39
    Sponsor's Protocol Code Number:BGB-A317-303
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2018-000245-39
    A.3Full title of the trial
    A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti−PD1 Antibody) Compared with Docetaxel in Patients with Non−Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 study to investigate Efficacy and Safety of BGB-A317 in patients with Non−Small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberBGB-A317-303
    A.5.4Other Identifiers
    Name:INDNumber:135200
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBeiGene Ltd., c/o BeiGene USA Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBeiGene Ltd., c/o BeiGene USA Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene Ltd., c/o BeiGene USA Inc.
    B.5.2Functional name of contact pointBeiGene Clinical support
    B.5.3 Address:
    B.5.3.1Street Address1900 Powell Street, Suite 500
    B.5.3.2Town/ cityEmeryville
    B.5.3.3Post code94608
    B.5.3.4CountryUnited States
    B.5.6E-mailBeiGeneClinicalSupportUS@beigene.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTislelizumab
    D.3.2Product code BGB-A317
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTislelizumab
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.3Other descriptive nameBGN1; JHL2108
    D.3.9.4EV Substance CodeSUB189550
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Docetaxel AqVida 20 mg/ml konzentrat zur Herstellung einer Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderAqVida GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDocetaxel AqVida 20 mg/ml konzentrat zur Herstellung einer Infusionslösung
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOCETAXEL
    D.3.9.3Other descriptive nameDocetaxel trihydrate
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typesemi-synthetic, second-generation taxane derived from a compound found in the European yew tree, Taxus baccata.
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Previously treated Non−Small Cell Lung Cancer in the second or third line setting.
    E.1.1.1Medical condition in easily understood language
    Previously treated Non−Small Cell Lung Cancer in the second or third line setting.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy, as measured by overall survival (OS), of tislelizumab with docetaxel in the second- or third-line setting in patients with non-small cell lung cancer (NSCLC) who have progressed on a prior platinum-containing regimen. A comparison of the treatment arms will be performed in:
    o The intent-to-treat (ITT) analysis set
    o The program cell death protein ligand-1 (PD-L1) positive analysis set, where PD-L1 positive is defined as ≥25% of tumor cells (TCs) with PD-L1 membrane staining via the Ventana SP263 assay
    E.2.2Secondary objectives of the trial
    1. To compare the efficacy of tislelizumab and docetaxel as measured by objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in:
    o The ITT analysis set
    o The PD-L1 positive analysis set
    2. To compare health-related quality of life (HRQoL) between tislelizumab and docetaxel
    3. To evaluate the safety and tolerability of tislelizumab versus docetaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent and can understand and
    comply with the requirements of the study and the schedule of assessments.
    2. Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
    3. Histologically confirmed disease which is currently locally advanced or
    metastatic NSCLC of either squamous or non-squamous histology.
    4. With disease progression during or following treatment with at least
    one platinum-containing regimen.
    • Patients who received prior neo-adjuvant or adjuvant chemotherapy
    but progressed within 6 months after last dose are eligible provided the
    target lesion(s) have not been previously treated with local therapy
    (radiation) or the target lesion(s) within the field of local therapy have
    subsequently progressed as defined per RECIST v1.1
    • Anti-EGFR treatment with disease progression as the treatment
    outcome is counted as a line of therapy.
    • Anticancer agents used for pleurodesis are not counted as a line of
    therapy.
    5. Patients must be able to provide archival/fresh tumor tissues (FFPE
    blocks or approximately 11 [at least 5] freshly cut unstained FFPE
    slides) for biomarker analysis to assess PD-L1 expression and, provided
    sufficient tissue, including tumor mutational burden (TMB), and gene
    expression profiling (GEP). Documentation of wild type status of EGFR
    by tissue-based test must be provided for patients with non-squamous
    NSCLC prior to enrollment. For undocumented cases, archival/fresh
    tumor tissues (FFPE blocks or 6 freshly cut unstained FFPE slides) are
    required for central assessment of EGFR mutation. In the absence of
    archival tumor tissues, a fresh biopsy of a tumor lesion at baseline
    (within 42 days before Cycle 1 Day 1) is mandatory (written informed
    consent is required prior to fresh tumor biopsies)..
    6. ECOG PS ≤1.
    7. Adequate hematologic and end-organ function, as defined by the
    following laboratory results (obtained ≤28 days prior to randomization):
    • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 ×
    109/L, and hemoglobin ≥ 90 g/L. Note: Patients must not have required
    a blood transfusion or growth factor support within the 14 days before
    sample collection
    • Estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73m2 by
    Chronic Kidney Disease Epidemiology Collaboration equation (Appendix
    6)
    • Total serum bilirubin ≤1.5 × upper limit of normal (ULN)
    - ≤3 × ULN, if Gilbert's syndrome or if indirect bilirubin concentrations
    are suggestive of extrahepatic source of the elevation
    • Aspartate and alanine aminotransferase (AST and ALT) ≤3 × ULN
    - ≤5 × ULN, if liver metastases
    8.Females of childbearing potential must be willing to practice highly effective method of birth control (Appendix 4) for the duration of the study, and, for patients in Arm A, for at least 120 days after the last dose of tislelizumab, and have a negative urine or serum pregnancy test within 7 days of randomization.
    9. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and, for patients in Arm A, for at least 120 days after the last dose of tislelizumab.
    10. Expected life span > 12 weeks.
    E.4Principal exclusion criteria
    1. Received prior docetaxel treatment for metastatic disease or prior
    immune checkpoint inhibitor therapies targeting PD-1, PD-L1 or CTLA-4.
    2. Diagnosed with NSCLC that harbors EGFR sensitizing or driver
    mutation or ALK gene translocation.
    3. Patients with toxicities (as a result of prior anticancer therapy including radiation) which
    have not recovered to baseline or stabilized except for AEs not
    constituting a likely safety risk including but not limited to alopecia,
    rash, pigmentation, specific laboratory abnormalities etc.
    4.Received chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin), or investigational agent, used to control cancer ≤ 28 days (or
    ≤ 5 half lives, whichever is shorter) prior to randomization.
    5. Received any herbal medicine used to control cancer within 14 days prior to randomization.
    6. History of severe hypersensitivity reactions to other mAbs.
    7. History of interstitial lung disease, non-infectious pneumonitis or
    uncontrolled systemic diseases, including diabetes, hypertension,
    pulmonary fibrosis, acute lung diseases, etc.
    8. Patients with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
    9. Clinically significant pericardial effusion.
    10. Clinically uncontrolled pleural effusion or ascites that requires
    pleurocentesis or abdominal tapping for drainage within 2 weeks prior to
    randomization.
    11. Active Leptomeningeal disease or uncontrolled, untreated brain
    metastasis as per protocol
    12. Major surgical procedure requiring general anesthesia, or significant traumatic injury ≤ 28 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study.
    •Placement of vascular access device is not considered major surgery.
    13. Malignancy other than NSCLC
    14. Severe chronic or active infections (including tuberculosis infection) requiring systemic antibacterial, antifungal, antiviral therapy, or systemic oral/IV antibiotics within 14 days prior to randomization.
    • Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
    15. A known history of human immunodeficiency virus (HIV) infection.
    16. Patients with active/symptomatic carrier or chronic hepatitis B virus (HBV) whose HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) should be excluded.
    17. Active autoimmune diseases or history of autoimmune diseases that
    may relapse should be excluded.
    18. Requiring systemic treatment with either corticosteroids (>10 mg
    daily prednisone or equivalent) or other immunosuppressive medications
    within 14 days of randomization.
    19. With uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before randomization.
    20. Any of the following cardiovascular criteria:
    • Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before randomization.
    • Symptomatic pulmonary embolism ≤ 28 days before randomization.
    • Acute myocardial infarction ≤6 months prior to randomization
    • Heart failure of New York Heart Association Classification III or IV
    (see Appendix 5) ≤6 months prior to randomization
    • Grade ≥2 ventricular arrhythmia ≤6 months prior to randomization
    • Cerebral vascular accident or transient ischemic attack ≤ 6 months prior to randomization.
    • Uncontrolled hypertension: systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg despite anti-hypertension medications ≤ 28 days before randomization.
    • Any episode of syncope or seizure ≤ 28 days before randomization.
    21. Prior allogeneic stem cell transplantation or organ transplantation.
    22. Was administered a live vaccine ≤ 4 weeks before randomization. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines, and are not allowed ≤ 4 weeks before randomization.
    23. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or impaired compliance with study conduct.
    24. Concurrent participation in another therapeutic clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    OS - defined as the time from the date of randomization to the date of death due to any cause in the ITT and PD-L1 positive analysis set.
    E.5.1.1Timepoint(s) of evaluation of this end point
    as per protocol
    E.5.2Secondary end point(s)
    • ORR – defined as the proportion of patients in the ITT and PD-L1 positive analysis set who had a CR or PR as assessed by the investigator per RECIST v1.1
    • DoR – defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the investigator per RECIST v1.1, or death from any cause, whichever comes first, in the ITT and PD-L1 positive analysis set.
    • PFS – defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first, in the ITT and PD-L1 positive analysis set.
    • HRQoL – measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) and Core 30 (EORTC QLQ-C30), and European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) scale
    • Incidence and severity of TEAEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Bulgaria
    China
    Lithuania
    Mexico
    New Zealand
    Poland
    Russian Federation
    Slovakia
    Turkey
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 615
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 185
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 800
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
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