Study Stopped
BeiGene and Celgene Corporation terminated the parties' global collaboration for the compound, pending the acquisition of Celgene by Bristol Myers Squibb
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
RATIONALE001
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
3 other identifiers
interventional
1
23 countries
164
Brief Summary
This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2019
Shorter than P25 for phase_3
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
May 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2019
CompletedResults Posted
Study results publicly available
July 15, 2020
CompletedJuly 15, 2020
June 1, 2020
1 month
November 9, 2018
June 26, 2020
June 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first. Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.
Up to approximately 5 years; date of randomization to the date of tumor progression or death; until study withdrawal date of 26 June 2019
Secondary Outcomes (10)
Overall Survival (OS)
Up to approximately 5 years; date of randomization to date of death from any cause.
Overall Survival at 24 Months
Up to approximately 24 months
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response
Up to approximately 5 years
Duration of Response
Up to approximately 5 years
Percentage of Participants Alive and Progression-Free at 12 Months (APF12)
Up to 12 months
- +5 more secondary outcomes
Study Arms (3)
Arm 1:Tislelizumab + cCRT followed by tislelizumab monotherapy
EXPERIMENTALTislelizumab 200 mg is administered by intravenous (IV) administration and given together upfront with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV adminstration monotherapy. The standard platinum-based chemotherapy options include carboplatin/ paclitaxel and cisplatin/etoposide
Arm 2: Placebo + cCRT followed by tislelizumab monotherapy
EXPERIMENTALPlacebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV administration monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide.
Arm 3: Placebo + cCRT followed by placebo monotherapy
PLACEBO COMPARATORPlacebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by placebo monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide.
Interventions
PD-1 inhibitor (monoclonal antibody against PD-1)
Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.
Placebo
Eligibility Criteria
You may qualify if:
- Newly diagnosed, histologically confirmed, locally advanced, stage III unresectable non small cell lung cancer (NSCLC).
- Staging will be confirmed at screening by positron emission tomography-computed tomography (PET/CT) and brain imaging by magnetic resonance imaging (MRI) or computed tomography (CT) with contrast.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene translocation status available prior to randomization.
- Provision of fresh or archival tumor tissue or discussion with Sponsor.
- Adequate hematologic and end-organ function.
You may not qualify if:
- Prior therapies including those targeting PD-1 or PD-L1 or chemotherapy, radiation, targeted therapy, biologic therapy, immunotherapy or investigational agent used to control non-small cell lung cancer (NSCLC).
- History of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen.
- History of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or clinically significant pericardial effusion.
- Any active malignancy less than or equal to 2 years before randomization, with the exception of non-small cell lung cancer (NSCLC) and any locally recurring cancer that has been treated curatively.
- Severe chronic or active infections including those requiring systemic antibacterial, antifungal or antiviral therapy; known human immunodeficiency virus (HIV) infection; untreated chronic hepatitis B or chronic hepatitis B virus carries or active hepatitis C; or active autoimmune disease.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Significant cardiovascular disease or other condition which places the patient at risk.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (164)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida, 32258-5472, United States
Bond Clinic, P.A.
Winter Haven, Florida, 33881, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46845, United States
Appalachian Regional Healthcare, Inc.
Hazard, Kentucky, 41701, United States
Norton Healthcare - Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Center For Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Dayton Physicians, LLC
Kettering, Ohio, 45409, United States
Mercy Health Youngstown Hospital, LLC
Youngstown, Ohio, 44504, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Millennium Oncology
Houston, Texas, 77090, United States
Medical Oncology Associates, P.S.
Spokane, Washington, 99208, United States
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021, China
Chinese PLA General Hospital / 307 Hospital
Beijing, 100071, China
Beijing Cancer Hospital - Beijing Institute for Cancer Research
Beijing, 100142, China
Bengbu Medical College - First Affiliated Hospital
Bengbu Shi, 233004, China
Jilin Province Cancer Hospital
Changchun, 130012, China
First Hospital of Jilin University
Changchun, 130021, China
Central South University - Xiangya School of Medicine - Hunan Cancer Hospital
Changsha, 410013, China
Central South University - Xiangya School of Medicine - Hunan Cancer Hospital
Changsha-shi, 410013, China
Sichuan Cancer Hospital & Institute
Chengdu, 610041, China
Sichuan University - West China Hospital
Chengdu, 610041, China
Foshan First People's Hospital
Foshan, 528000, China
Cancer Center of Guangzhou Medical University
Guangzhou, 510095, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
Zhejiang University School of Medicine - The Second Affiliated Hospital
Hangzhou, 310016, China
Zhejiang Medical University - Zhejiang Cancer Hospital
Hangzhou, 310022, China
The First Affiliated Hospital of Harbin Medical University
Harbin, 150081, China
Yunnan Cancer Hospital
Kunming, 650118, China
Guangxi Tumour Institute and Hospital
Nanning, 530021, China
Nantong Tumor Hospital
Nantong, 226361, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Shanghai Chest Hospital
Shanghai Shi, 200030, China
Chongqing Cancer Hospital
Shapingbaqu, 400030, China
Liaoning Cancer Hospital & Institute
Shenyang, 110042, China
The First Hospital of Xinjiang Medical University
Ürümqi, 830054, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022, China
Zhongnan Hospital of Wuhan University
Wuhan, 430023, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
First Hospital of Xiamen
Xiamen, 361003, China
Fujian Medical University - Fujian Provincial Cancer Hospital
Xidajie, 350014, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221002, China
Zhengzhou University (ZZU) - Henan Cancer Hospital
Zhengzhou, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
Tampereen yliopistollinen sairaala
Tampere, 33521, Finland
Turku University Hospital
Turku, 20521, Finland
Centre Francois Baclesse
Caen, 14076, France
Clinique Victor Hugo
Le Mans, 72015, France
Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain
Saint-Herblain, 44805, France
Medical Study Company NORD-WEST GmbH Oncology Aurich
Aurich, 26603, Germany
Helios Klinikum Emil Von Behring
Berlin, 14165, Germany
Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim
Cologne, 51109, Germany
Florence Nightingale KH der Kaiserwerther Diakonie
Düsseldorf, 40489, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730, Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82131, Germany
Oncological practice Goslar
Goslar, 38642, Germany
Evangelisches Krankenhaus Hamm
Hamm, 59063, Germany
Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV
Kassel, 34125, Germany
Klinik Loewenstein gGmbH
Löwenstein, 74245, Germany
LMU Klinikum der Universität
München, 81377, Germany
St. Antonius-Hospital
Schweiler, 52249, Germany
Medizinische Studiengesellschaft Nord-West
Westerstede, 26655, Germany
Sotiria Chest Hospital of Athens
Athens, 11527, Greece
IASO General
Athens, 15562, Greece
University General Hospital of Heraklion
Heraklion, 71110, Greece
Agioi Anargyroi Cancer Hospital
Kifissia, 14564, Greece
Metaxa Cancer Hospital of Piraeus
Piraeus, 18537, Greece
Interbalkan Medical Center of Thessaloniki
Pylaia, 570 01, Greece
University General Hospital of Patras
Rio Patras, 26500, Greece
Bioclinic Thessaloniki Galinos clinic
Thessaloniki, 54622, Greece
EUROMEDICA General Clinic of Thessaloniki
Thessaloniki, 54645, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56429, Greece
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Pulmonary Institute Torokbalint
Törökbálint, 2045, Hungary
Beacon Hospital
Dublin, D18 AK68, Ireland
St James Hospital
Dublin, Dublin 8, Ireland
MidWestern Regional Hospital
Limerick, Ireland
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico
Catania, 95123, Italy
IRCCS AziendaOspedaliera Universitaria San Martino
Genova, 16132, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola, 47014, Italy
Universita Campus Bio-Medico di Roma
Roma, 00128, Italy
Istituto Nazionale Tumori Regina Elena di Roma
Roma, 00144, Italy
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino-shi, 583-8588, Japan
Kansai Medical University Hospital
Hirakata-shi, 573-1191, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Kanazawa University Hospital
Kanazawa, Japan
Matsusaka Municipal Hospital
Matsusaka-shi, 515-8544, Japan
Toranomon Hospital
Minatoku, 105-8470, Japan
Iwate Medical University Hospital
Morioka, 020-8505, Japan
National Hospital Organization - Nagoya Medical Center
Nagoya, 460-0001, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Gunma Prefectural Cancer Center
Ōta-ku, 373-8550, Japan
Kitasato University Hospital
Sagamihara, 252-0375, Japan
Sendai Kousei Hospital
Sendai, 980-0873, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, 236-0051, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, 240-8555, Japan
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, 1081 HV, Netherlands
Gelre Hospitals
Zutphen, 7207 AE, Netherlands
Waikato Hospital
Hamilton, 3204, New Zealand
Tauranga Hospital
Tauranga, 3112, New Zealand
Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, 85796, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Gliwice, 44-101, Poland
Med Polonia Sp. z o.o. NSZOZ
Poznan, 60-693, Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Hospital Prof. Doutor Fernando Fonseca
Amadora, 2720-276, Portugal
Centro Hospitalar E Universitario de Coimbra EPE
Coimbra, 3000-075, Portugal
Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes
Guimarães, 4835-044, Portugal
CUF Descobertas Hospital
Lisbon, 1998-018, Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4099-001, Portugal
CUF Porto Hospital
Porto, 4100-180, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
Porto, 4200-072, Portugal
Oncology Institute Professor Doctor Alexandru Trestioreanu
Bucharest, 022328, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015, Romania
Medisprof SRL
Cluj-Napoca, 400058, Romania
Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
Constanța, 900591, Romania
Oncology Center Sfantul Nectarie
Craiova, Romania
Life Search SRL
Timișoara, 300167, Romania
Oncocenter Clinical Oncology
Timișoara, 300210, Romania
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, 105229, Russia
Omsk Regional Oncology Center
Omsk, 610013, Russia
Ryazan State Medical University n.a. I.P. Pavlov
Ryazan, 390026, Russia
Clinical Hospital of the Russian Academy of Sciences
Saint Petersburg, 194017, Russia
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg, 197758, Russia
Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov
Saint Petersburg, 197758, Russia
Mordovia State University
Saransk, 43002, Russia
National University Hospital
Singapore, 119074, Singapore
Raffles Hospital
Singapore, 188770, Singapore
Chungbuk National University Hospital
Cheongju-si, 138-736, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hospital Universitario a Coruna
A Coruña, 15006, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, 08916, Spain
Insular-Maternal and Child University Hospital Complex
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital General Carlos Haya
Málaga, 29010, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Buddhist Dalin Tzu Chi General Hospital
Dalin, 62247, Taiwan
E-DA Hospital
Kaohsiung City, 82445, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, San Ming Dist., 807, Taiwan
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital
Niao-Sung Hsiang Kaohsiung County, 83301, Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist., 100, Taiwan
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital
Colchester, CO4 5JL, United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London, NW1 2BU, United Kingdom
Guys Hospital
London, SE1 9RT, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre
Manchester, M23 9LT, United Kingdom
The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital
Northwood, HA6 2RN, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
Sheffield South Yorkshire, S10 2SS, United Kingdom
Royal Cornwall Hospitals Trust
Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne McClain
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
Marie Nguyen, MD
Celgene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2018
First Posted
November 19, 2018
Study Start
May 22, 2019
Primary Completion
June 26, 2019
Study Completion
June 26, 2019
Last Updated
July 15, 2020
Results First Posted
July 15, 2020
Record last verified: 2020-06