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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)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
Concurrent chemoradiotherapy (cCRT)
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Locally Advanced, Unresectable Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Randomized, BGB-A317, Tislelizumab, PD-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.

  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  3. Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene translocation status available prior to randomization.
  4. Provision of fresh or archival tumor tissue or discussion with Sponsor.
  5. Adequate hematologic and end-organ function.

Exclusion Criteria:

  1. 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).
  2. History of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen.
  3. History of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or clinically significant pericardial effusion.
  4. 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.
  5. 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.
  6. Prior allogeneic stem cell transplantation or organ transplantation.
  7. Significant cardiovascular disease or other condition which places the patient at risk.

Sites / Locations

  • USC Norris Comprehensive Cancer Center
  • Cancer Specialists of North Florida - Jacksonville
  • Bond Clinic, P.A.
  • University of Chicago Medical Center
  • Fort Wayne Medical Oncology and Hematology
  • Appalachian Regional Healthcare, Inc.
  • Norton Healthcare - Norton Cancer Institute
  • Center For Cancer and Blood Disorders
  • University of Mississippi Medical Center
  • Dayton Physicians, LLC
  • Mercy Health Youngstown Hospital, LLC
  • Allegheny General Hospital
  • Millennium Oncology
  • Medical Oncology Associates, P.S.
  • Universitair Ziekenhuis Brussel
  • Cliniques Universitaires Saint-Luc
  • Jewish General Hospital
  • Cancer Hospital Chinese Academy of Medical Sciences
  • Chinese PLA General Hospital / 307 Hospital
  • Beijing Cancer Hospital - Beijing Institute for Cancer Research
  • Bengbu Medical College - First Affiliated Hospital
  • Jilin Province Cancer Hospital
  • First Hospital of Jilin University
  • Central South University - Xiangya School of Medicine - Hunan Cancer Hospital
  • Central South University - Xiangya School of Medicine - Hunan Cancer Hospital
  • Sichuan Cancer Hospital & Institute
  • Sichuan University - West China Hospital
  • Foshan First People's Hospital
  • Fujian Medical University - Fujian Provincial Cancer Hospital
  • Cancer Center of Guangzhou Medical University
  • The First Affiliated Hospital of Guangzhou Medical University
  • Zhejiang University School of Medicine - The Second Affiliated Hospital
  • Zhejiang Medical University - Zhejiang Cancer Hospital
  • The First Affiliated Hospital of Harbin Medical University
  • Yunnan Cancer Hospital
  • Guangxi Tumour Institute and Hospital
  • Nantong Tumor Hospital
  • Shanghai Chest Hospital
  • Fudan University Shanghai Cancer Center
  • Chongqing Cancer Hospital
  • Liaoning Cancer Hospital & Institute
  • The First Hospital of Xinjiang Medical University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Zhongnan Hospital of Wuhan University
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • First Hospital of Xiamen
  • The Affiliated Hospital of Xuzhou Medical University
  • Zhengzhou University (ZZU) - Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Tampereen yliopistollinen sairaala
  • Turku University Hospital
  • Centre Francois Baclesse
  • Clinique Victor Hugo
  • Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain
  • Medical Study Company NORD-WEST GmbH Oncology Aurich
  • Helios Klinikum Emil Von Behring
  • Florence Nightingale KH der Kaiserwerther Diakonie
  • Klinikum Esslingen GmbH
  • Asklepios Fachkliniken Muenchen Gauting
  • Oncological practice Goslar
  • Evangelisches Krankenhaus Hamm
  • Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV
  • Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim
  • Klinik Loewenstein gGmbH
  • LMU Klinikum der Universität
  • St. Antonius-Hospital
  • Medizinische Studiengesellschaft Nord-West
  • Sotiria Chest Hospital of Athens
  • IASO General
  • University General Hospital of Heraklion
  • Agioi Anargyroi Cancer Hospital
  • Metaxa Cancer Hospital of Piraeus
  • Interbalkan Medical Center of Thessaloniki
  • University General Hospital of Patras
  • Bioclinic Thessaloniki Galinos clinic
  • EUROMEDICA General Clinic of Thessaloniki
  • Papageorgiou General Hospital of Thessaloniki
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Pulmonary Institute Torokbalint
  • Beacon Hospital
  • St James Hospital
  • MidWestern Regional Hospital
  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico
  • IRCCS AziendaOspedaliera Universitaria San Martino
  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
  • Universita Campus Bio-Medico di Roma
  • Istituto Nazionale Tumori Regina Elena di Roma
  • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
  • Kansai Medical University Hospital
  • Hiroshima University Hospital
  • Kanazawa University Hospital
  • Matsusaka Municipal Hospital
  • Toranomon Hospital
  • Iwate Medical University Hospital
  • National Hospital Organization - Nagoya Medical Center
  • Nagoya University Hospital
  • Niigata Cancer Center Hospital
  • Osaka City University Hospital
  • Gunma Prefectural Cancer Center
  • Kitasato University Hospital
  • Sendai Kousei Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Yokohama Municipal Citizen's Hospital
  • Chungbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Ajou University Hospital
  • Vrije Universiteit Medisch Centrum (VUMC)
  • Gelre Hospitals
  • Waikato Hospital
  • Tauranga Hospital
  • Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
  • Med Polonia Sp. z o.o. NSZOZ
  • Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
  • Hospital Prof. Doutor Fernando Fonseca
  • Centro Hospitalar E Universitario de Coimbra EPE
  • Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes
  • CUF Descobertas Hospital
  • Centro Hospitalar do Porto - Hospital de Santo António
  • CUF Porto Hospital
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
  • Oncology Institute Professor Doctor Alexandru Trestioreanu
  • Prof. Dr. I. Chiricuta Institute of Oncology
  • Medisprof SRL
  • Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
  • Oncology Center Sfantul Nectarie
  • Life Search SRL
  • Oncocenter Clinical Oncology
  • Principal Military Clinical Hospital n.a. N.N. Burdenko
  • Omsk Regional Oncology Center
  • Ryazan State Medical University n.a. I.P. Pavlov
  • Mordovia State University
  • Clinical Hospital of the Russian Academy of Sciences
  • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
  • Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov
  • National University Hospital
  • Raffles Hospital
  • Hospital Universitario a Coruna
  • Hospital General Universitario de Alicante
  • Hospital Universitario Germans Trias i Pujol
  • Insular-Maternal and Child University Hospital Complex
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Puerta de Hierro-Majadahonda
  • Hospital General Carlos Haya
  • Hospital Universitario Central de Asturias
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Buddhist Dalin Tzu Chi General Hospital
  • Kaohsiung Medical University Hospital
  • E-DA Hospital
  • Chang Gung Medical Foundation, Kaohsiung Memorial Hospital
  • National Taiwan University Hospital
  • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
  • East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital
  • University College London Hospitals NHS Foundation Trust - University College Hospital
  • Guys Hospital
  • Royal Marsden Hospital
  • Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital
  • Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre
  • The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital
  • Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
  • Royal Cornwall Hospitals Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1:Tislelizumab + cCRT followed by tislelizumab monotherapy

Arm 2: Placebo + cCRT followed by tislelizumab monotherapy

Arm 3: Placebo + cCRT followed by placebo monotherapy

Arm Description

Tislelizumab 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

Placebo 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.

Placebo 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
Overall survival was defined as the time between randomization of treatment and death from any cause.
Overall Survival at 24 Months
Overall survival was defined as the time between randomization of treatment and death from any cause.
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response
Overall Response was defined as percentage of participants who had a radiologic confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines, between Day 1 of treatment and subsequent anti-cancer therapy, death or study discontinuation. Complete response was defined as the disappearance of all target lesions; partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD).
Duration of Response
Duration of Response is 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.
Percentage of Participants Alive and Progression-Free at 12 Months (APF12)
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
Percentage of Participants Alive and Progression-free at 18 Months (APF18)
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
Time to Distant Metastasis (TTDM)
TTDM was 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 was defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs include any adverse events (AEs) that had an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurred first. TEAEs also included all immune-related AEs recorded up to 90 days after the last dose of tislelizumab or placebo, regardless of whether or not the particpant started a new anticancer therapy. In addition, any serious AE with an onset date more than 30 days after the last dose of study drug that is assessed by the investigator as related to study drug were considered a TEAE."
Number of Participants With Lung Cancer Symptoms Assessed by the Corresponding Domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and Lung-Cancer Specific QLQ-LC13
The EORTC QLQ-C30 is a 30-item, questionnaire assessing quality of life (QoL), psychosocial burden and physical symptoms. It is classified into 15 domains: 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); each item is measured on a 4 point response scale; (not at all, a little, quite a bit, very much), with the exception of the 2 items measuring global health and QoL, (measured on a 7-point response scale). Scores are linearly transformed to 0 to 100 scores. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions; higher scores = better QoL, better functioning, or more severe symptoms, respectively. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss.
Percentage of Participants Who Would Have Continued on to Monotherapy Phase
Included the percentage of participants who would have received at least one dose of tislelizumab or placebo in the monotherapy phase before progression.

Full Information

First Posted
November 9, 2018
Last Updated
June 26, 2020
Sponsor
Celgene
Collaborators
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03745222
Brief Title
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
Acronym
RATIONALE001
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
BeiGene and Celgene Corporation terminated the parties' global collaboration for the compound, pending the acquisition of Celgene by Bristol Myers Squibb
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
Collaborators
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Locally Advanced, Unresectable Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Randomized, BGB-A317, Tislelizumab, PD-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1:Tislelizumab + cCRT followed by tislelizumab monotherapy
Arm Type
Experimental
Arm Description
Tislelizumab 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 Title
Arm 2: Placebo + cCRT followed by tislelizumab monotherapy
Arm Type
Experimental
Arm Description
Placebo 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 Title
Arm 3: Placebo + cCRT followed by placebo monotherapy
Arm Type
Placebo Comparator
Arm Description
Placebo 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.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
PD-1 inhibitor (monoclonal antibody against PD-1)
Intervention Type
Drug
Intervention Name(s)
Concurrent chemoradiotherapy (cCRT)
Intervention Description
Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival was defined as the time between randomization of treatment and death from any cause.
Time Frame
Up to approximately 5 years; date of randomization to date of death from any cause.
Title
Overall Survival at 24 Months
Description
Overall survival was defined as the time between randomization of treatment and death from any cause.
Time Frame
Up to approximately 24 months
Title
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response
Description
Overall Response was defined as percentage of participants who had a radiologic confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines, between Day 1 of treatment and subsequent anti-cancer therapy, death or study discontinuation. Complete response was defined as the disappearance of all target lesions; partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD).
Time Frame
Up to approximately 5 years
Title
Duration of Response
Description
Duration of Response is 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.
Time Frame
Up to approximately 5 years
Title
Percentage of Participants Alive and Progression-Free at 12 Months (APF12)
Description
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
Time Frame
Up to 12 months
Title
Percentage of Participants Alive and Progression-free at 18 Months (APF18)
Description
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
Time Frame
Up to approximately 18 months
Title
Time to Distant Metastasis (TTDM)
Description
TTDM was 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 was defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy.
Time Frame
Up to approximately 5 years
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
TEAEs include any adverse events (AEs) that had an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurred first. TEAEs also included all immune-related AEs recorded up to 90 days after the last dose of tislelizumab or placebo, regardless of whether or not the particpant started a new anticancer therapy. In addition, any serious AE with an onset date more than 30 days after the last dose of study drug that is assessed by the investigator as related to study drug were considered a TEAE."
Time Frame
From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days.
Title
Number of Participants With Lung Cancer Symptoms Assessed by the Corresponding Domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and Lung-Cancer Specific QLQ-LC13
Description
The EORTC QLQ-C30 is a 30-item, questionnaire assessing quality of life (QoL), psychosocial burden and physical symptoms. It is classified into 15 domains: 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); each item is measured on a 4 point response scale; (not at all, a little, quite a bit, very much), with the exception of the 2 items measuring global health and QoL, (measured on a 7-point response scale). Scores are linearly transformed to 0 to 100 scores. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions; higher scores = better QoL, better functioning, or more severe symptoms, respectively. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss.
Time Frame
Up to approximately 5 years
Title
Percentage of Participants Who Would Have Continued on to Monotherapy Phase
Description
Included the percentage of participants who would have received at least one dose of tislelizumab or placebo in the monotherapy phase before progression.
Time Frame
Up to approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Nguyen, MD
Organizational Affiliation
Celgene
Official's Role
Study Director
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cancer Specialists of North Florida - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258-5472
Country
United States
Facility Name
Bond Clinic, P.A.
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33881
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Appalachian Regional Healthcare, Inc.
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Norton Healthcare - Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Center For Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Dayton Physicians, LLC
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Mercy Health Youngstown Hospital, LLC
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44504
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Millennium Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Medical Oncology Associates, P.S.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Chinese PLA General Hospital / 307 Hospital
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Beijing Cancer Hospital - Beijing Institute for Cancer Research
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Bengbu Medical College - First Affiliated Hospital
City
Bengbu Shi
ZIP/Postal Code
233004
Country
China
Facility Name
Jilin Province Cancer Hospital
City
Changchun Shi
ZIP/Postal Code
130012
Country
China
Facility Name
First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Central South University - Xiangya School of Medicine - Hunan Cancer Hospital
City
Changsha-shi
ZIP/Postal Code
410013
Country
China
Facility Name
Central South University - Xiangya School of Medicine - Hunan Cancer Hospital
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Sichuan Cancer Hospital & Institute
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan University - West China Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Foshan First People's Hospital
City
Foshan
ZIP/Postal Code
528000
Country
China
Facility Name
Fujian Medical University - Fujian Provincial Cancer Hospital
City
Fuzhou Shi
ZIP/Postal Code
350014
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510095
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Zhejiang University School of Medicine - The Second Affiliated Hospital
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Medical University - Zhejiang Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming Shi
ZIP/Postal Code
650118
Country
China
Facility Name
Guangxi Tumour Institute and Hospital
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
ZIP/Postal Code
226361
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai Shi
ZIP/Postal Code
200030
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Chongqing Cancer Hospital
City
Shapingbaqu
ZIP/Postal Code
400030
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang Shi
ZIP/Postal Code
110042
Country
China
Facility Name
The First Hospital of Xinjiang Medical University
City
Urumqi
ZIP/Postal Code
830054
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430023
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an City
ZIP/Postal Code
710061
Country
China
Facility Name
First Hospital of Xiamen
City
Xiamen
ZIP/Postal Code
361003
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
ZIP/Postal Code
221002
Country
China
Facility Name
Zhengzhou University (ZZU) - Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
Tampereen yliopistollinen sairaala
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Centre Francois Baclesse
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Medical Study Company NORD-WEST GmbH Oncology Aurich
City
Aurich
ZIP/Postal Code
26603
Country
Germany
Facility Name
Helios Klinikum Emil Von Behring
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Florence Nightingale KH der Kaiserwerther Diakonie
City
Dusseldorf
ZIP/Postal Code
40489
Country
Germany
Facility Name
Klinikum Esslingen GmbH
City
Esslingen Am Neckar
ZIP/Postal Code
73730
Country
Germany
Facility Name
Asklepios Fachkliniken Muenchen Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Oncological practice Goslar
City
Goslar
ZIP/Postal Code
38642
Country
Germany
Facility Name
Evangelisches Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
59063
Country
Germany
Facility Name
Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim
City
Koln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Klinik Loewenstein gGmbH
City
Loewenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
LMU Klinikum der Universität
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
St. Antonius-Hospital
City
Schweiler
ZIP/Postal Code
52249
Country
Germany
Facility Name
Medizinische Studiengesellschaft Nord-West
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Sotiria Chest Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
IASO General
City
Athens
ZIP/Postal Code
15562
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Agioi Anargyroi Cancer Hospital
City
Kifissia
ZIP/Postal Code
14564
Country
Greece
Facility Name
Metaxa Cancer Hospital of Piraeus
City
Piraeus
ZIP/Postal Code
18537
Country
Greece
Facility Name
Interbalkan Medical Center of Thessaloniki
City
Pylaia
ZIP/Postal Code
570 01
Country
Greece
Facility Name
University General Hospital of Patras
City
Rio Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Bioclinic Thessaloniki Galinos clinic
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
EUROMEDICA General Clinic of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Papageorgiou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Pulmonary Institute Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Beacon Hospital
City
Dublin
ZIP/Postal Code
D18 AK68
Country
Ireland
Facility Name
St James Hospital
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Facility Name
MidWestern Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
IRCCS AziendaOspedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Universita Campus Bio-Medico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena di Roma
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
City
Habikino-shi
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Kansai Medical University Hospital
City
Hirakata-shi
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa-shi
Country
Japan
Facility Name
Matsusaka Municipal Hospital
City
Matsusaka-shi
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
National Hospital Organization - Nagoya Medical Center
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota-ku
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Sendai-shi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama-shi
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Yokohama Municipal Citizen's Hospital
City
Yokohama-shi
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Vrije Universiteit Medisch Centrum (VUMC)
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Gelre Hospitals
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85796
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Med Polonia Sp. z o.o. NSZOZ
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Prof. Doutor Fernando Fonseca
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Centro Hospitalar E Universitario de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
CUF Descobertas Hospital
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
CUF Porto Hospital
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Oncology Institute Professor Doctor Alexandru Trestioreanu
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Prof. Dr. I. Chiricuta Institute of Oncology
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Oncology Center Sfantul Nectarie
City
Craiova
Country
Romania
Facility Name
Life Search SRL
City
Timisoara
ZIP/Postal Code
300167
Country
Romania
Facility Name
Oncocenter Clinical Oncology
City
Timisoara
ZIP/Postal Code
300210
Country
Romania
Facility Name
Principal Military Clinical Hospital n.a. N.N. Burdenko
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Omsk Regional Oncology Center
City
Omsk
ZIP/Postal Code
610013
Country
Russian Federation
Facility Name
Ryazan State Medical University n.a. I.P. Pavlov
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Mordovia State University
City
Saransk
ZIP/Postal Code
43002
Country
Russian Federation
Facility Name
Clinical Hospital of the Russian Academy of Sciences
City
St. Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Raffles Hospital
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Facility Name
Hospital Universitario a Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Insular-Maternal and Child University Hospital Complex
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro-Majadahonda
City
Majadahonda, Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Buddhist Dalin Tzu Chi General Hospital
City
Dalin
ZIP/Postal Code
62247
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung, San Ming Dist.
ZIP/Postal Code
807
Country
Taiwan
Facility Name
E-DA Hospital
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital
City
Niao-Sung Hsiang Kaohsiung County
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei, Zhongzheng Dist.
ZIP/Postal Code
100
Country
Taiwan
Facility Name
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust - University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
City
Sheffield South Yorkshire
ZIP/Postal Code
S10 2SS
Country
United Kingdom
Facility Name
Royal Cornwall Hospitals Trust
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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