A 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

PHASE3TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

May 22, 2019

Primary Completion Date

June 26, 2019

Study Completion Date

June 26, 2019

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Tislelizumab

PD-1 inhibitor (monoclonal antibody against PD-1)

DRUG

Concurrent chemoradiotherapy (cCRT)

Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.

OTHER

Placebo

Placebo

Trial Locations (164)

100

National Taiwan University Hospital, Taipei, Zhongzheng Dist.

807

Kaohsiung Medical University Hospital, Kaohsiung, San Ming Dist.

1090

Universitair Ziekenhuis Brussel, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

2045

Pulmonary Institute Torokbalint, Törökbálint

3112

Tauranga Hospital, Tauranga

3204

Waikato Hospital, Hamilton

5505

Asan Medical Center, Seoul

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

11527

Sotiria Chest Hospital of Athens, Athens

13620

Seoul National University Bundang Hospital, Seongnam-si

14076

Centre Francois Baclesse, Caen

14165

Helios Klinikum Emil Von Behring, Berlin

14564

Agioi Anargyroi Cancer Hospital, Kifissia

15006

Hospital Universitario a Coruna, A Coruña

15212

Allegheny General Hospital, Pittsburgh

15562

IASO General, Athens

16132

IRCCS AziendaOspedaliera Universitaria San Martino, Genova

16499

Ajou University Hospital, Suwon

18537

Metaxa Cancer Hospital of Piraeus, Piraeus

20521

Turku University Hospital, Turku

20817

Center For Cancer and Blood Disorders, Bethesda

26500

University General Hospital of Patras, Rio Patras

26603

Medical Study Company NORD-WEST GmbH Oncology Aurich, Aurich

26655

Medizinische Studiengesellschaft Nord-West, Westerstede

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28222

Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda, Madrid

29010

Hospital General Carlos Haya, Málaga

33011

Hospital Universitario Central de Asturias, Oviedo

33521

Tampereen yliopistollinen sairaala, Tampere

33881

Bond Clinic, P.A., Winter Haven

34125

Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV, Kassel

35016

Insular-Maternal and Child University Hospital Complex, Las Palmas de Gran Canaria

38642

Oncological practice Goslar, Goslar

39216

University of Mississippi Medical Center, Jackson

40202

Norton Healthcare - Norton Cancer Institute, Louisville

40489

Florence Nightingale KH der Kaiserwerther Diakonie, Düsseldorf

41701

Appalachian Regional Healthcare, Inc., Hazard

43002

Mordovia State University, Saransk

44504

Mercy Health Youngstown Hospital, LLC, Youngstown

44805

Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain, Saint-Herblain

45409

Dayton Physicians, LLC, Kettering

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

46845

Fort Wayne Medical Oncology and Hematology, Fort Wayne

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola

51109

Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim, Cologne

52249

St. Antonius-Hospital, Schweiler

54622

Bioclinic Thessaloniki Galinos clinic, Thessaloniki

54645

EUROMEDICA General Clinic of Thessaloniki, Thessaloniki

56429

Papageorgiou General Hospital of Thessaloniki, Thessaloniki

59063

Evangelisches Krankenhaus Hamm, Hamm

60637

University of Chicago Medical Center, Chicago

62247

Buddhist Dalin Tzu Chi General Hospital, Dalin

71110

University General Hospital of Heraklion, Heraklion

72015

Clinique Victor Hugo, Le Mans

73730

Klinikum Esslingen GmbH, Esslingen am Neckar

74245

Klinik Loewenstein gGmbH, Löwenstein

77090

Millennium Oncology, Houston

81377

LMU Klinikum der Universität, München

82131

Asklepios Fachkliniken Muenchen Gauting, Gauting

82445

E-DA Hospital, Kaohsiung City

83301

Chang Gung Medical Foundation, Kaohsiung Memorial Hospital, Niao-Sung Hsiang Kaohsiung County

85796

Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz

90033

USC Norris Comprehensive Cancer Center, Los Angeles

95123

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico, Catania

99208

Medical Oncology Associates, P.S., Spokane

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100071

Chinese PLA General Hospital / 307 Hospital, Beijing

100142

Beijing Cancer Hospital - Beijing Institute for Cancer Research, Beijing

105229

Principal Military Clinical Hospital n.a. N.N. Burdenko, Moscow

110042

Liaoning Cancer Hospital & Institute, Shenyang

119074

National University Hospital, Singapore

130012

Jilin Province Cancer Hospital, Changchun

130021

First Hospital of Jilin University, Changchun

150081

The First Affiliated Hospital of Harbin Medical University, Harbin

188770

Raffles Hospital, Singapore

194017

Clinical Hospital of the Russian Academy of Sciences, Saint Petersburg

197758

GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), Saint Petersburg

Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov, Saint Petersburg

200030

Shanghai Chest Hospital, Shanghai Shi

200032

Fudan University Shanghai Cancer Center, Shanghai

221002

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

226361

Nantong Tumor Hospital, Nantong

233004

Bengbu Medical College - First Affiliated Hospital, Bengbu Shi

300167

Life Search SRL, Timișoara

300210

Oncocenter Clinical Oncology, Timișoara

310016

Zhejiang University School of Medicine - The Second Affiliated Hospital, Hangzhou

310022

Zhejiang Medical University - Zhejiang Cancer Hospital, Hangzhou

350014

Fujian Medical University - Fujian Provincial Cancer Hospital, Xidajie

361003

First Hospital of Xiamen, Xiamen

390026

Ryazan State Medical University n.a. I.P. Pavlov, Ryazan

400015

Prof. Dr. I. Chiricuta Institute of Oncology, Cluj-Napoca

400030

Chongqing Cancer Hospital, Shapingbaqu

400058

Medisprof SRL, Cluj-Napoca

410013

Central South University - Xiangya School of Medicine - Hunan Cancer Hospital, Changsha

Central South University - Xiangya School of Medicine - Hunan Cancer Hospital, Changsha-shi

430022

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

430023

Zhongnan Hospital of Wuhan University, Wuhan

430030

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan

450008

Zhengzhou University (ZZU) - Henan Cancer Hospital, Zhengzhou

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

510095

Cancer Center of Guangzhou Medical University, Guangzhou

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

528000

Foshan First People's Hospital, Foshan

530021

Guangxi Tumour Institute and Hospital, Nanning

610013

Omsk Regional Oncology Center, Omsk

610041

Sichuan Cancer Hospital & Institute, Chengdu

Sichuan University - West China Hospital, Chengdu

650118

Yunnan Cancer Hospital, Kunming

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

830054

The First Hospital of Xinjiang Medical University, Ürümqi

900591

Sf. Apostol Andrei Constanta Emergency Clinical County Hospital, Constanța

32258-5472

Cancer Specialists of North Florida - Jacksonville, Jacksonville

H3T 1E2

Jewish General Hospital, Montreal

570 01

Interbalkan Medical Center of Thessaloniki, Pylaia

D18 AK68

Beacon Hospital, Dublin

Dublin 8

St James Hospital, Dublin

Unknown

MidWestern Regional Hospital, Limerick

Kanazawa University Hospital, Kanazawa

Oncology Center Sfantul Nectarie, Craiova

00128

Universita Campus Bio-Medico di Roma, Roma

00144

Istituto Nazionale Tumori Regina Elena di Roma, Roma

583-8588

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino-shi

573-1191

Kansai Medical University Hospital, Hirakata-shi

734-8551

Hiroshima University Hospital, Hiroshima

515-8544

Matsusaka Municipal Hospital, Matsusaka-shi

105-8470

Toranomon Hospital, Minatoku

020-8505

Iwate Medical University Hospital, Morioka

460-0001

National Hospital Organization - Nagoya Medical Center, Nagoya

466-8560

Nagoya University Hospital, Nagoya

951-8566

Niigata Cancer Center Hospital, Niigata

545-8586

Osaka City University Hospital, Osaka

373-8550

Gunma Prefectural Cancer Center, Ōta-ku

252-0375

Kitasato University Hospital, Sagamihara

980-0873

Sendai Kousei Hospital, Sendai

236-0051

Kanagawa Cardiovascular and Respiratory Center, Yokohama

240-8555

Yokohama Municipal Citizen's Hospital, Yokohama

1081 HV

Vrije Universiteit Medisch Centrum (VUMC), Amsterdam

7207 AE

Gelre Hospitals, Zutphen

44-101

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Gliwice

60-693

Med Polonia Sp. z o.o. NSZOZ, Poznan

02-781

Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie, Warsaw

2720-276

Hospital Prof. Doutor Fernando Fonseca, Amadora

3000-075

Centro Hospitalar E Universitario de Coimbra EPE, Coimbra

4835-044

Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes, Guimarães

1998-018

CUF Descobertas Hospital, Lisbon

4099-001

Centro Hospitalar do Porto - Hospital de Santo António, Porto

4100-180

CUF Porto Hospital, Porto

4200-072

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe, Porto

022328

Oncology Institute Professor Doctor Alexandru Trestioreanu, Bucharest

138-736

Chungbuk National University Hospital, Cheongju-si

03010

Hospital General Universitario de Alicante, Alicante

08916

Hospital Universitario Germans Trias i Pujol, Barcelona

B15 2TH

University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital, Birmingham

CO4 5JL

East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital, Colchester

NW1 2BU

University College London Hospitals NHS Foundation Trust - University College Hospital, London

SE1 9RT

Guys Hospital, London

SW3 6JJ

Royal Marsden Hospital, London

ME16 9QQ

Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital, Maidstone

M23 9LT

Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre, Manchester

HA6 2RN

The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital, Northwood

S10 2SS

Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital, Sheffield South Yorkshire

TR1 3LJ

Royal Cornwall Hospitals Trust, Truro

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

BeiGene

INDUSTRY

lead

Celgene

INDUSTRY