A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04746924
Collaborator
(none)
605
224
3
46.8
2.7
0.1

Study Details

Study Description

Brief Summary

The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
605 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date :
Jun 8, 2021
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Tislelizumab plus Ociperlimab

Participants will receive ociperlimab 900 mg intravenously followed by tislelizumab 200 milligrams (mg) intravenously once every 3 weeks.

Drug: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Other Names:
  • BGB-A317
  • Drug: Ociperlimab
    Ociperlimab is a monoclonal antibody formulated for intravenous injection.
    Other Names:
  • BGB-A1217
  • Active Comparator: Arm B: Pembrolizumab plus Placebo

    Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

    Drug: Pembrolizumab
    Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
    Other Names:
  • KEYTRUDA
  • Drug: Placebo
    Placebo infusions will consist of a sterile, normal saline solution.

    Placebo Comparator: Arm C: Tislelizumab plus Placebo

    Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

    Drug: Tislelizumab
    Tislelizumab is a monoclonal antibody formulated for intravenous injection.
    Other Names:
  • BGB-A317
  • Drug: Placebo
    Placebo infusions will consist of a sterile, normal saline solution.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) As Assessed By Investigators [Up to approximately 40 months]

      PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first.

    2. Overall Survival (OS) As Assessed By Investigators [Up to approximately 40 months]

      OS will be defined as the time from the date of randomization to the date of death due to any cause.

    Secondary Outcome Measures

    1. PFS As Assessed By A Blinded Independent Review Committee [Up to approximately 40 months]

      PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first.

    2. Overall Response Rate (ORR) As Assessed By Investigators [Up to approximately 40 months]

      ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.

    3. Duration Of Response (DOR) As Assessed By Investigators [Up to approximately 40 months]

      DOR will be defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.

    4. Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) [Within 7 days after last dose]

      HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome

    5. HRQoL: EORTC Lung Cancer Module Quality Of Life Questionnaire Lung Cancer 13 (QLQ-LC13) [Within 7 days after last dose]

      HRQoL will be assessed via PRO using the EORTC QLQ-LC13. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.

    6. HRQoL: The 5 Level EuroQol 5 Dimension (EQ-5D-5L) Questionnaire [Within 7 days after last dose]

      HRQoL will be assessed via PRO using the EQ-5D-5L. EQ-5D-5L - Is the EuroQol 5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    7. Time To Deterioration (TDD) [Within 7 days after last dose]

      TDD will be analyzed using the global health status of QLQ-C30 and will be defined as worsening scores for 2 consecutive assessments or 1 assessment followed by death from any cause.

    8. Number Of Participants Experiencing Adverse Events (AEs) [90 days (±14) after last dose]

      The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.

    2. No prior systemic treatment for metastatic NSCLC.

    3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).

    4. Tumors with PD-L1 tumor cell ≥ 50% expression.

    5. At least 1 measurable lesion as defined per RECIST v1.1.

    6. ECOG Performance Status ≤ 1.

    Key Exclusion Criteria:
    1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.

    2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

    3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

    4. Active autoimmune diseases or history of autoimmune diseases that may relapse.

    Note: Other protocol defined Inclusion/Exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAB O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Alaska Oncology and Hematology, LLC Anchorage Alaska United States 99508
    3 Providence Medical Foundation Fullerton California United States 92835
    4 Ocala Oncology, Florida Cancer Affiliates Ocala Florida United States 34474
    5 Advent Health Oncology and Hematology Orlando Florida United States 32804
    6 Goshen Center for Cancer Care Goshen Indiana United States 46526
    7 Baptist Health Lexington Lexington Kentucky United States 40503
    8 West Jefferson Medical Center Cancer Center (University Medical Center New Orleans) Marrero Louisiana United States 70072
    9 Central Maine Medical Center Lewiston Maine United States 04240
    10 HealthPartners Institute - MMCORC (Metro Minnesota Community Oncology Research Consortium) Saint Paul Minnesota United States 55426
    11 XCancer / Central Care Cancer Center Bolivar Missouri United States 65613
    12 Penn State Health Cancer Institute Hershey Pennsylvania United States 17033
    13 West Penn Hospital (Allegheny Health Network) Pittsburgh Pennsylvania United States 15224
    14 Virginia Cancer Specialist, PC Fairfax Virginia United States 22031
    15 Concord Repatriation General Hospital Concord New South Wales Australia 2139
    16 Northern Cancer Institute, Genesis Care Saint Leonards New South Wales Australia 2065
    17 Calvary Mater Newcastle, Medical Oncology Trial Unit, Edith Street Waratah New South Wales Australia 2298
    18 Pindara Private Hospital Benowa Queensland Australia 4217
    19 The Prince Charles Hospital Chermside Queensland Australia 4032
    20 Mater Cancer Care Centre South Brisbane Queensland Australia 4101
    21 John Flynn Private Hospital Tugun Queensland Australia 4224
    22 Lyell McEwin Hospital Elizabeth Vale South Australia Australia 5112
    23 Ballarat Health Services Ballarat Victoria Australia 3350
    24 Monash Health Clayton Victoria Australia 3168
    25 Western Health - Sunshine Hospital St Albans Victoria Australia 3021
    26 St John of God, Murdoch Hospital Murdoch Western Australia Australia 6150
    27 Anhui Provincial Hospital Hefei Anhui China 230000
    28 Beijing Cancer Hospital Beijing Beijing China 100142
    29 Beijing Chest Hospital, Capital Medical University Beijing Beijing China 10149
    30 Southwest Hospital Chongqing Chongqing China 400038
    31 Chongqing Three Gorges Central Hospital Chongqing Chongqing China 404000
    32 Fujian Medical University Union Hospital Fuzhou Fujian China 350001
    33 Fujian Cancer Hospital Fuzhou Fujian China 350014
    34 The First Affiliated Hospital of Xiamen University Xiamen Fujian China 361003
    35 Cancer Center of Guangzhou Medical University Guangzhou Guangdong China 510030
    36 Cancer Hospital of Shantou University Medical College Shantou Guangdong China 515031
    37 Shenzhen People's Hospital Shenzhen Guangdong China 518020
    38 Cancer Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi China 530021
    39 The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi China 530021
    40 Affiliated Tumor Hospital of Harbin Medical University Harbin Heilongjiang China 150000
    41 The First Affiliated Hospital of Zhengfzhou University Zhengzhou Henan China 400052
    42 Henan Cancer Hospital Zhengzhou Henan China 450000
    43 Henan Provincial People's Hospital Zhengzhou Henan China 450003
    44 Hubei Cancer Hospital Wuhan Hubei China 400037
    45 Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430023
    46 Renmin Hospital of Wuhan University Wuhan Hubei China 430060
    47 The Second Xiangya Hospital of Central South University Changsha Hunan China 410011
    48 Nanjing First Hospital Nanjing Jiangsu China 210009
    49 Nanjing Chest Hospital Nanjing Jiangsu China 210029
    50 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006
    51 Liaoning Cancer Hospital & Institute Shenyang Liaoning China 110042
    52 The Affiliated Hospital of Qingdao University Qingdao Shandong China 266000
    53 Weifang People's Hospital Weifang Shandong China 261000
    54 Shanghai Chest Hospital Shanghai Shanghai China 200030
    55 Shanxi Bethune Hospital Taiyuan Shanxi China 030032
    56 Sichuan Cancer Hospital & Institute Chengdu Sichuan China 610041
    57 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    58 Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin China 300060
    59 Affiliated Cancer Hospital of Xinjiang Medical University Ürümqi Xinjiang China 830000
    60 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China 310016
    61 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    62 Ningbo First Hospital Ningbo Zhejiang China 315010
    63 Beijing Chao-Yang Hospital Beijing China 100020
    64 Peking Union Medical College Hospital Beijing China 100730
    65 Hunan Cancer Hospital Changsha China 410013
    66 Changzhou No.2 People's Hospital Changzhou China 213003
    67 West China Hospital, Sichuan University Chengdu China 610041
    68 Chongqing Cancer Hospital Chongqing China 400030
    69 Daping Hospital, Third Military Medical University Chongqing China 400042
    70 The First Affiliated Hospital of Guangzhou Medical University Guangzhou China 510120
    71 The Second Hospital of Anhui Medical University Hefei China 230601
    72 The First Affiliated Hospital of Nanchang University Nanchang China 330006
    73 Affiliated Hospital of North Sichuan Medical College Nanchong China 637000
    74 Affiliated Zhongshan Hospital of Fudan University Shanghai China 200032
    75 Shanghai Pulmonary Hospital Shanghai China 200433
    76 The Second Affiliated Hospital of Soochow University Suzhou China 215000
    77 Taizhou Hospital of Zhejiang Province Taizhou China 317000
    78 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China 710061
    79 Xuzhou Central Hospital Xuzhou China 221000
    80 Yantai Yuhuangding Hospital Yantai China 264000
    81 The Fourth Affiliated Hospital Zhejinaang University School of Medicine Yiwu China 322000
    82 Institut de Cancérologie de L'Ouest Angers France 49055
    83 Centre Hospitalier de la Cote Basque - Saint Léon - Service de Pneumologie Bayonne France 64109
    84 Hospices Civils de Lyon- Hopital Louis Pradel Bron France 69500
    85 CHI de Creteuil Créteil France 94000
    86 Hospices Civils de Lyon-Hôpital de la Croix Rousse Lyon France 69004
    87 Centre Leon Berard Lyon France 69373
    88 ICM Val Daurelle - Oncologie Médicale Montpellier France 34298
    89 Centre Hospitalier Emile Muller Ghrmsa Mulhouse France 68100
    90 Clinique Gentilly Nancy France 54100
    91 Hopital Cochin Paris France 75014
    92 Hospices Civils de Lyon- Centre Hospitalier Lyon Sud Pierre-Bénite France 69310
    93 HIA Begin Saint-Mandé France 94160
    94 Chu Tours - Hopital Bretonneau - Service Pneumologie 2 Tours France 37000
    95 High Technology Hospital Medcenter LTD Batumi Georgia 6000
    96 Acad. Fridon Todua medical Center LTD - Research Institute of Clinical Medicine LTD Tbilisi Georgia 0112
    97 Israel-Georgian Medical Research Clinic Helsicore LTD Tbilisi Georgia 0112
    98 Multiprofile Clinic Consilium Medula LTD Tbilisi Georgia 0186
    99 Oncology Research Center LTD Tbilisi Georgia 0186
    100 Timi - Tbilisi Institute of Medicine LTD Tbilisi Georgia 0186
    101 Universitaetsklinikum Aachen Aachen Germany 52074
    102 Helios Klinikum Bad Saarow Bad Saarow Germany 15526
    103 Charite Universitatsmedizin Berlin Berlin Germany 13353
    104 Asklepios Fachklinik Munchen-Gauting Gauting Germany 82131
    105 Lungenclinic Grosshansdorf GMBH Großhansdorf Germany 22927
    106 Ambulantes Krebszentrum Hamburg Hamburg Germany 20251
    107 Uniklinikum Giessen Marburg Heidelberg Germany 35392
    108 Universitatsklinikum Bonn Kiel Germany 53127
    109 Kliniken Der Stadt Koeln GGMBH Köln Germany 51109
    110 Onkologische Scwerpunktpraxis Leer - Emden Leer Germany 26789
    111 Klinikum Ludwigshafen, Medizinische Klinik A Ludwigshafen Germany 67063
    112 Klinikum Johannes-Gutenberg-Universitaet Mainz Mainz Germany 55131
    113 Klinikum Der Universitat muenchen - Campus Innenstadt Muenchen Germany 80336
    114 Muenchen Klinik Bogenhausen Muenchen Germany 80336
    115 Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige GMBH Rotenburg Germany 27356
    116 Universitaetsklinikum Ulm, Innere Medizin III Ulm Germany 89081
    117 Onkologische Schwerpunkt-Praxis-Worms Worms Germany 57547
    118 Cro Irccs Aviano Via Franco Gallini Aviano Italy 33081
    119 Istituto Romagnolo per Studio, dei Tumori "Dino Amadori" Meldola Italy 47017
    120 Azienda Ospedaliera Papardo Messina Italy 98158
    121 Ospedale San Raffaele Milano Italy 20132
    122 Aou San Luigi Gonzaga Orbassano Italy 10043
    123 Arcispedale S. Maria Nuova - Ausl Reggio Emilia - Oncologia Reggio Emilia Italy 42123
    124 Azienda Ospedaliera Universitaria Integrata Di Verona Verona Italy 37126
    125 Nagoya University Hospital Nagoya Aichi Japan 003-0804
    126 Kobe City Medical Center General Hospital Kobe Hyogo Japan 650-0047
    127 Okayama University Hospital Okayama-shi Okayama-ken Japan 700-8558
    128 Cancer Institute Hospital of JFCR Koto-ku Tokyo-To Japan 135-8550
    129 Kanagawa Cancer Center Kanagawa Japan 241-8515
    130 Nagaoka Red Cross Hospital Niigata Japan 940-2085
    131 The Catholic University of Korea, Bucheon St. Mary's Hospital Gyeonggi-do Bucheon-si Korea, Republic of 14647
    132 Kyungpook National University Chilgok Hospital Daegu Buk-gu Korea, Republic of 41404
    133 Chungbuk National University Hospital Cheongju-si Chungcheongbuk-do Korea, Republic of 28644
    134 Keimyung University Dongsan Hospital Daegu Dalseo-gu Korea, Republic of 42601
    135 The Catholic University of Korea Eunpyeong St. Mary's Hospital Seoul Eunpyeong-gu Korea, Republic of 03312
    136 Inje University Haeundae Paik Hospital Busan Haeundae-gu Korea, Republic of 48108
    137 Meander Medisch Centrum Amersfoort Netherlands 3813
    138 Stichting Het Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis Amsterdam Netherlands 1066
    139 Rijnstate Arnhem Netherlands 6815
    140 Ziekenhuis St Jansdal Harderwijk Netherlands 3844
    141 Stichting Zuyderland Medisch Centrum Heerlen Netherlands 6419
    142 Isala Klinieken Zwolle Zwolle Netherlands 8025
    143 Uniwersytecki Szpital Kliniczny w Białymstoku Białystok Poland 15-276
    144 Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością Gdynia Poland
    145 Przychodnia Med-Polonia Sp. z o.o. Poznan Poland 60-693
    146 Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi Łódź Poland
    147 Arkhangelsk Regional Clinical Oncological Dispensary Arkhangel'sk Russian Federation 163045
    148 State Budgetary Healthcare Institution-Chelyabinsk Regional Clinical Center of Oncology and Nuclear Chelyabinsk Russian Federation 454087
    149 Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical" Kursk Russian Federation 305035
    150 State Budgetary Healthcare Institution-Regional Oncology Dispensary Number 2 Magnitogorsk Russian Federation 455001
    151 "Vitamed" LLC Moscow Russian Federation 121309
    152 State Budgetary Healthcare Institution "City Clinical Hospital #1" Nalchik Russian Federation 360000
    153 State Budgetary Healthcare Institution - Nizhny Novgorod Regional Clinical Oncology Dispensary Nizhny Novgorod Russian Federation 603081
    154 BIH of OMSK Region "Clinical Oncology Dispensary" Omsk Russian Federation 644013
    155 Private Healthcare Institution - Clinical Hospital Russian Railways - Medicine of the City of St. Petersburg Saint Petersburg Russian Federation 195271
    156 Private Medical Institution "Evromedservis" Saint Petersburg Russian Federation 196603
    157 LLC AV-Medical Group Saint Petersburg Russian Federation 197082
    158 The Smorodintsev Research Institute of Influenze Saint Petersburg Russian Federation 197376
    159 FSBI "Clinical Research and Practical Center for Specialized Medical Care (Oncology)" Saint Petersburg Russian Federation 197758
    160 FSBI "National Medical Research Center for Oncology N.A.N.N. Petrov" of the MOH of the RF Saint Petersburg Russian Federation 197758
    161 State Budgetary Healthcare Institution - Samara Regional Clinical Oncology Dispensary Samara Russian Federation 443031
    162 Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Morodov" Saransk Russian Federation 430032
    163 State Autonomous Healthcare Institution - Republican Clinical Oncological Dispensary of the Republic Ufa Russian Federation 450054
    164 ICO-H.U.G. Trias I Pujol Badalona Spain 08916
    165 Hospital Del Mar Barcelona Spain 08003
    166 Hospital Universitari Quiron Dexeus Barcelona Spain 08028
    167 Hospital Universitario Vall D'Hebron Barcelona Spain 8035
    168 Hospital Universitario Donostia Donostia Spain 20014
    169 Hospital General Universitario de Elche Elche Spain 03203
    170 ICO Girona Girona Spain 17007
    171 Hospital Universitario Insularde Gran Canaria Las Palmas Spain 35016
    172 Hospital Universitario Lucus Augusti Lugo Spain 27003
    173 Hospital Clinico San Carlos Madrid Spain 28040
    174 Start Madrid-Fundacion Jimenez Diaz Madrid Spain 28040
    175 Hospital Universitario Doce de Octubre Madrid Spain 28041
    176 Hospital Universitario La Paz Madrid Spain 28046
    177 Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Spain 28220
    178 Hospital General Universitario Morales Meseguer Murcia Spain 30008
    179 Hospital Universitario Virgen de la Victoria Málaga Spain 29010
    180 Hospital Regional Universitario de Malaga Málaga Spain 29011
    181 Complexo Hospitalario Universitario de Ourense Orense Spain 32005
    182 Hospital Universitari son Espases Palma De Mallorca Spain 07120
    183 Hospital Universitario Nuestra Señora de Valme Sevilla Spain 41014
    184 Consorcio Hospital General Universitario de Valencia Valencia Spain 46014
    185 Hospital Arnau de Vilanova Valencia Spain 46015
    186 Hospital Universitari I Politecnic La Fe Valencia Spain 46026
    187 Changhua Christian Hospital Changhua Taiwan 50006
    188 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 83301
    189 Chung Shan Medical University Hospital Taichung Taiwan 40201
    190 China Medical University Hospital Taichung Taiwan 40447
    191 Taichung Veterans General Hospital Taichung Taiwan 40705
    192 Taipei Veterans General Hospital Taipei Taiwan 11217
    193 Taipei Tzu Chi Hospital Taipei Taiwan 231405
    194 Linkou Chang Gung Memorial Hospital Taoyuan Taiwan 33305
    195 National Taiwan University Hospital Yunlin Branch Yuanlin Taiwan 00640
    196 Chulabhorn Research Institute Bangkok Thailand 10210
    197 Siriraj Hospital Bangkok Thailand 10700
    198 Songklanagarind Hospital (Prince of Songkhla University) Hat Yai Thailand 90110
    199 Srinagarind Hospital (Khon Kaen University) Mueang Nonthaburi Thailand 40002
    200 Bangkok Hospital Chiang Mai Mueang Nonthaburi Thailand 50000
    201 Phramongkutklao Hospital Ratchathewi Thailand 10400
    202 Rajavithi Hospital Ratchathewi Thailand 10400
    203 Acibadem Adana Hospital Adana Turkey 01130
    204 Baskent University Practice and Research Hospital Adana - Medical Oncology Department Adana Turkey 01240
    205 İInönü Üniversitesi Tip Fakültesi Battalgazi Turkey 44280
    206 Trakya University Medical Faculty Edirne Turkey 22030
    207 Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Istanbul Turkey 34096
    208 Istanbul Medeniyet Uni Goztepe Training & Res Hosp Istanbul Turkey 34854
    209 Ege University Medical Faculty İzmir Turkey 35100
    210 Necmettin Erbakan University Selcuklu Faculty of Medicine Meram Turkey 42090
    211 Bukovynian Clinical Oncology Center Chernivtsi Ukraine 58013
    212 Komunalne Nekomertsiine Pidryiemstvo - Miska Klinichna Likarnia #4 Dnepropetrovsk Ukraine 49102
    213 Komunalne Nekomertsiine Pidryiemstvo Oblasnyi Tsentr Onkolohii Kharkiv Ukraine 61070
    214 Kryvyi RIH Oncological Dispensary Kryvyi Rih Ukraine 50048
    215 Medical Center "Verum" Limited Liability Company Kyiv Ukraine 03039
    216 Public Non-profit Institution "Kyiv City Clinical Oncology Center" Kyiv Ukraine 03115
    217 Volyn Regional Medical Center of Oncology Luts'k Ukraine 43018
    218 Lviv State Regional Oncology Treatment and Diagnostic Center Lviv Ukraine 79031
    219 Odessa Regional Oncological Dispensary Odesa Ukraine 65010
    220 Communal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar Sumy Ukraine 40003
    221 Zakarpatska Regional Clinical Oncological Center Uzhgorod Ukraine 88011
    222 Podolsk Regional Oncology Center Vinnytsia Ukraine 21029
    223 Zaporozhye Regional Antitumor Center Zaporizhia Ukraine 69061
    224 Medical Center of Llc Oncolife Zaporizhzhya Ukraine 69059

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Principal Investigator: Shun Lu, Shanghai Chest Hospital
    • Principal Investigator: Mark Socinski, Advent Health Orlando

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04746924
    Other Study ID Numbers:
    • AdvanTIG-302
    • BGB-A317-A1217-302
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by BeiGene
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 27, 2022