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

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. .

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Other: Placebo; Drug: Tislelizumab; Drug: Concurrent chemoradiotherapy (cCRT)

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1:Tislelizumab + cCRT followed by tislelizumab monotherapy; 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	Drug: Tislelizumab; PD-1 inhibitor (monoclonal antibody against PD-1); Other Names: BGB-A317; Drug: Concurrent chemoradiotherapy (cCRT); Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.
EXPERIMENTAL: Arm 2: Placebo + cCRT followed by tislelizumab monotherapy; 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.	Other: Placebo; Placebo; Drug: Tislelizumab; PD-1 inhibitor (monoclonal antibody against PD-1); Other Names: BGB-A317; Drug: Concurrent chemoradiotherapy (cCRT); Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.
PLACEBO_COMPARATOR: Arm 3: Placebo + cCRT followed by placebo monotherapy; 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.	Other: Placebo; Placebo; Drug: Concurrent chemoradiotherapy (cCRT); Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival was defined as the time between randomization of treatment and death from any cause.	Up to approximately 5 years; date of randomization to date of 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.	Up to approximately 24 months
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).	Up to approximately 5 years
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.	Up to approximately 5 years
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	Up to 12 months
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	Up to approximately 18 months
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.	Up to approximately 5 years
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."	From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days.
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.	Up to approximately 5 years
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.	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Celgene
• Collaborators: BeiGene
• Investigators: Study Director: Marie Nguyen, MD, Celgene

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2019
• Primary Completion (ACTUAL): June 26, 2019
• Study Completion (ACTUAL): June 26, 2019

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (ACTUAL): November 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; Randomized; PD-1; Tislelizumab; BGB-A317; Locally Advanced, Unresectable Non-Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BGB-A317-NSCL-001; U1111-1216-4294 (OTHER: WHO); 2018-001132-22 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No