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    Summary
    EudraCT Number:2018-001132-22
    Sponsor's Protocol Code Number:BGB-A317-NSCL-001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-07
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-001132-22
    A.3Full title of the trial
    A Phase 3, Randomized, Blinded, Placebo-controlled Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects with Locally Advanced, Unresectable Non-Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the safety and efficacy of tislelizumab treatment on its own after a period of combined tislelizumab plus chemoradiotherapy treatment in patients with non-small cell lung cancer that cannot be removed surgically
    A.4.1Sponsor's protocol code numberBGB-A317-NSCL-001
    A.5.4Other Identifiers
    Name:INDNumber:138358
    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 SponsorCelgene Corporation
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinical Trial Disclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park
    B.5.3.3Post codeKS 66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18882601599
    B.5.5Fax number+19132660394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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.3.9.4EV 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 typehumanized monoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-small cell lung cancer (NSCLC)
    E.1.1.1Medical condition in easily understood language
    Cancer of the lung which is not of the small cell carcinoma type
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025052
    E.1.2Term Lung cancer non-small cell stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025053
    E.1.2Term Lung cancer non-small cell stage IIIA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025061
    E.1.2Term Lung cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080083
    E.1.2Term Advanced 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
    The primary objective is to compare the progression free survival (PFS) of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy (Arm 1) versus cCRT alone (Arm 3); in addition, tislelizumab given sequentially after cCRT (Arm 2) will be compared with cCRT alone (Arm 3) in newly diagnosed stage III subjects with locally advanced unresectable non-small cell lung cancer (NSCLC).
    E.2.2Secondary objectives of the trial
    • Compare overall survival (OS)
    • Compare OS at 24 months
    • Compare centrally assessed objective response rate (ORR)
    • Compare centrally assessed duration of response (DOR)
    • Compare proportion of subjects alive and progression-free at 12 and 18 months (APF12, APF18)
    • Compare time to death or distant metastasis (TTDM)
    • Compare safety and tolerability of tislelizumab in combination cCRT followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone
    • Compare impact on patient-reported lung cancer symptoms (appetite loss, cough, chest pain, dyspnea, and fatigue) assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and its lung cancer module (EORTC QLQ-LC13)
    • Compare the proportion of subjects who received at least one dose of tislelizumab or placebo in the monotherapy phase before progression in Arm 1 versus Arm 2 and 3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
    2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
    3. Subject has newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCLC.
    4. Subject must have EGFR mutation and ALK gene translocation status available (testing using tumor tissue only) prior to randomization.
    5. Subjects must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin embedded [FFPE] blocks or at least 15 to 20 freshly cut unstained FFPE slides) with an associated pathological report (squamous or nonsquamous). In the absence of archival tumor tissues, a fresh biopsy (a minimum of 2 to 3 cores) of a tumor lesion at baseline is mandatory. Subjects may be permitted to be enrolled on a case-by-case basis after discussion with the Sponsor medical monitor if fewer than 15 unstained slides can be provided.
    6. Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
    7. Subject has adequate hematologic and end-organ function, as defined by the following laboratory results (obtained ≤ 2 weeks prior to randomization):
    a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    b. Platelet count ≥ 100 x 10^9/L
    c. Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (≥ 28 days after growth factor support or transfusion)
    d. Calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula) for subjects receiving cisplatin/etoposide, and ≥ 45 mL/min (Cockcroft-Gault formula) for subjects receiving carboplatin/paclitaxel.
    e. Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3 x ULN, if Gilbert’s syndrome or if indirect bilirubin concentrations are suggestive of extrahepatic source of the elevation)
    f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
    8. A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must:
    a. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy.
    b. Agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study treatment; 2) while taking study treatment; 3) during dose interruptions; and 4) for at least 120 days after the subject’s last dose of tislelizumab or placebo and 180 days after the subject’s last dose of chemotherapy. The 2 methods of reliable contraception must include one highly effective method and one additional effective (barrier) method.
    9. Male subjects must:
    a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 120 days after the subject’s last dose of tislelizumab or placebo and 180 days after the subject’s last dose of chemotherapy, or longer if required by local regulations, even if he has undergone a successful vasectomy.
    b. Agree to not donate sperm
    10. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
    E.4Principal exclusion criteria
    1. Subject has received prior therapies targeting PD-1 or PD-L1.
    2. Subject has received chemotherapy, radiation, targeted therapy, biologic therapy, immunotherapy or investigational agent used to control NSCLC.
    3. Subject has a history of severe hypersensitivity reactions to other monoclonal antibodies.
    4. Subject has a history of interstitial lung disease or documented ongoing interstitial lung disease or history of pneumonitis that has required oral or intravenous steroids.
    5. Subject’s radiation treatment plans are likely to encompass a volume of whole lung receiving ≥ 20 Gy in total (V20) of more than 38% of lung volume.
    6. Subject has clinically significant pericardial effusion.
    7. Subject has clinically uncontrolled pleural effusion or ascites that requires pleurocentesis or paracentesis for drainage within 2 weeks prior to randomization.
    8. Subject has had a major surgical procedure, open biopsy, or significant traumatic injury ≤14 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study.
    9. Subject has any active malignancy ≤ 2 years before randomization, with the exception of NSCLC and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
    10. Subject has severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection.
    11. Subject has known Human Immunodeficiency Virus (HIV) infection.
    12. Subject has untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV deoxyribonucleic acid (DNA) > 500 IU/mL (2500 copies/mL), or active hepatitis C.
    13. Subject has active autoimmune diseases or history of autoimmune diseases that may relapse. Subjects with the following diseases are allowed to be enrolled after further screening: type I diabetes, hypothyroidism managed with hormone replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia), or diseases not expected to recur in the absence of external triggering factors.
    14. Subject has medical conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of randomization.
    15. Subject has any of the following cardiovascular criteria:
    a. Evidence of acute or ongoing cardiac ischemia
    b. Current symptomatic pulmonary embolism
    c. Acute myocardial infarction ≤ 6 months prior to randomization
    d. Heart failure of New York Heart Association Classification III or IV ≤ 6 months prior to randomization
    e. Grade ≥ 2 ventricular arrhythmia ≤ 6 months prior to randomization
    f. Cerebral vascular accident or transient ischemic attack ≤ 6 months prior to randomization
    16. Subject has had prior allogeneic stem cell transplantation or organ transplantation.
    17. Subject has used any live vaccines against infectious diseases (eg, varicella, zoster, etc.) within 4 weeks (28 days) of randomization. Seasonal influenza vaccines that do not contain live virus are permitted.
    18. Subject has used any herbal or patent medicines to control cancer or boost immunity within 14 days of the first study treatment administration.
    19. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
    20. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
    21. Subject has any condition that confounds the ability to interpret data from the study.
    22. Subject has a contraindication to the planned chemotherapy regimen to be administered on the study.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by blinded independent central review per RECIST v1.1 or death from any cause, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 weeks post C1D1 for the first 36 weeks and then every 9 weeks until disease progression, new disease therapy, death or withdrawal of consent.
    E.5.2Secondary end point(s)
    1. Overall survival (OS) defined as the time from the date of randomization to the date of death due to any cause.
    2. OS at 24 months defined as the proportion of subjects alive at 24 months after randomization.
    3. Objective response rate (ORR) defined as the proportion of subjects in the ITT population who had complete response (CR) or partial response (PR) as assessed by blinded independent central review per RECIST v1.1.
    4. Duration of response (DoR) defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by blinded independent central review per RECIST v1.1, or death from any cause, whichever comes first.
    5. Proportion of subjects alive and progression-free at 12 months (APF12) defined as the Kaplan-Meier estimate of progression-free survival (PFS) at 12 months.
    6. Proportion of subjects alive and progression-free at 18 months (APF18) defined as the Kaplan-Meier estimate of progression-free survival (PFS) at 18 months.
    7. Time to distant metastasis (TTDM) defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy.
    8. Safety and tolerability will be assessed from adverse events (using NCI CTCAE v5.0), laboratory tests, vital signs, ECOG performance status, physical
    exams, concomitant medications, and dose modifications.
    9. Impact on the selected patientreported lung cancer symptoms (appetite loss, cough, chest pain, dyspnea, and fatigue) assessed by the corresponding domains in EORTC QLQ-C30 and its lung cancer module (EORTC QLQLC13).
    10. Proportion of subjects who continue to monotherapy phase defined as proportion of subjects who receive at least one dose of tislelizumab or placebo in the monotherapy phase before progression as determined by blinded independent central review per RECIST v1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Overall survival (OS): Randomization to death.
    2. OS at 24 months: Randomization to 24 months.
    3-7. ORR; DoR; APF12; APF18; TTDM will be assessed every 6 weeks post C1D1 for the first 36 weeks and then every 9 weeks until disease progression, new disease therapy, death or withdrawal of consent.
    8. Safety and tolerability will be assessed from signature of informed consent through 90 days after the last dose of study treatment.
    9. Impact on the selected patientreported lung cancer symptoms will be assessed based on tislelizumab/placebo 21-day cycle and at discontinuation of the study treatment and 30 days after the last dose of tislelizumab/placebo.
    10. Proportion of subjects who continue to monotherapy phase: Randomization to the first dose in the monotherapy phase.
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA108
    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
    Australia
    Belgium
    Canada
    Chile
    China
    Finland
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Romania
    Russian Federation
    Singapore
    Spain
    Switzerland
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The End of Trial is defined as either the date of the last visit of the last subject to complete the posttreatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as prespecified in the protocol, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 462
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 378
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 405
    F.4.2.2In the whole clinical trial 840
    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)
    Best standard of care at investigatior's discretion.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-26
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