Study Stopped
This decision was conducted by the sponsor based on lack of efficacy and not driven by safety concerns.
A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
5 other identifiers
interventional
669
19 countries
218
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with high levels of programmed cell death ligand-1 (PD-L1), locally advanced/recurrent or untreated metastatic non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started May 2021
218 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
February 5, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2026
CompletedResults Posted
Study results publicly available
May 12, 2026
CompletedMay 12, 2026
April 1, 2026
4 years
February 5, 2021
March 25, 2026
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall Survival (OS) in Arms A and B
OS is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. OS was a pre-specified primary endpoint for Arms A and B only.
From randomization until the end of the study. Maximum time on study was 45.0 months
Safety Run-In Substudy: Number of Participants Experiencing Adverse Events (AEs)
The severity of AEs was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0). AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being the least severe and Grade 5 being the most severe. An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, was considered a significant medical AE by the investigator based on medical judgement.
From first dose of study drug to 30 days after last dose. Maximum treatment duration was 12.45 months.
Safety Run-In Substudy: Serum Concentration of Ociperlimab
Cycle 1 Day 1 (C1D1) Postdose (30 minutes after end of infusion), 24 and 72 Hours Postdose; C1D8; C1D15; C2D1 Predose and Postdose; C5D1 Predose; C5D1 Postdose; C5D8; C5D15; C6D1 Predose and Postdose; C9D1 Predose; C13D1 Predose; End of Treatment.
Secondary Outcomes (13)
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Up to 45.0 months
Progression-free Survival (PFS) for Safety Run-In Substudy As Assessed By the Investigator
Up to 38.9 months
Overall Response Rate (ORR) for Arm A Versus Arm B As Assessed By the Investigator
Response was assessed every 9 weeks from randomization for the first 52 weeks and then every 12 weeks thereafter, up to 45.0 months
Overall Response Rate (ORR) for Safety Run-In Substudy As Assessed By the Investigator
Response was assessed every 9 weeks from randomization for the first 52 weeks and then every 12 weeks thereafter, up to 38.9 months
Duration Of Response (DOR) for Arm A Versus Arm B As Assessed By the Investigator
Up to 45.0 months
- +8 more secondary outcomes
Study Arms (4)
Arm A: Ociperlimab plus Tislelizumab
EXPERIMENTALParticipants received ociperlimab 900 mg and tislelizumab 200 mg intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
Arm B: Pembrolizumab plus Placebo
ACTIVE COMPARATORParticipants received pembrolizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
Arm C: Tislelizumab plus Placebo
PLACEBO COMPARATORParticipants received tislelizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
Safety Run-In Substudy
EXPERIMENTALJapanese participants received ociperlimab 900 mg and tislelizumab 200 mg every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
Interventions
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
Placebo infusions will consist of a sterile, normal saline solution.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.
- No prior systemic treatment for metastatic NSCLC.
- Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
- Tumors with PD-L1 expressed in ≥ 50% tumor cells.
- At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
You may not qualify if:
- Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
- Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (218)
Providence Medical Foundation St Jude Heritage Healthcare
Fullerton, California, 92835, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
Ocala, Florida, 34474, United States
Advent Health Cancer Institute
Orlando, Florida, 32804, United States
Goshen Center For Cancer Care
Goshen, Indiana, 46526, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University Medical Center New Orleans West Jefferson Medical Center
New Orleans, Louisiana, 70112, United States
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota, 55101, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Centro Medical Austral
Buenos Aires, 1409, Argentina
Centro Para La Atencion Del Paciente Oncologico (Caipo)
San Miguel de Tucumán, 4000, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Northern Cancer Institute
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Pindara Private Hospital
Benowa, Queensland, 4217, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Mater Cancer Care Centre
South Brisbane, Queensland, 4101, Australia
John Flynn Private Hospital
Tugun, Queensland, 4224, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Ballarat Health Services
Ballarat, Victoria, 3350, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Western Health Sunshine Hospital
St Albans, Victoria, 3021, Australia
St John of God, Murdoch
Murdoch, Western Australia, 6150, Australia
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, 70390140, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, 29308-020, Brazil
Centro de Pesquisas Oncologicas Cepon
Florianópolis, 88034-000, Brazil
Cancer Institute of Ceara
Fortaleza, 60430-235, Brazil
Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, 09060-650, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
The First Affiliated Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, 400038, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Chongqing University Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
Shenzhen Peoples Hospital
Shenzhen, Guangdong, 518020, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
Changzhou, Jiangsu, 213003, China
Nanjing First Hospital
Nanjing, Jiangsu, 210009, China
Nanjing Chest Hospital
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou, Jiangsu, 215006, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
The Affiliated Hospital of Qingdao University Branch Laoshan
Qingdao, Shandong, 266000, China
Weifang Peoples Hospital
Weifang, Shandong, 261000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, 610041, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, 317000, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000, China
Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
Bayonne, 64100, France
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076, France
Hopital de La Croix Rousse
Lyon, 69317, France
Hopital Louis Pradel
Lyon, 69500, France
Icm Val Daurelle Oncologie Medicale
Montpellier, 24298, France
Polyclinique de Gentilly
Nancy, 54100, France
Hopital Cochin
Paris, 75014, France
Chu Hopital Lyon Sud
PierreBenite, 69495, France
Hia Begin
Saint-Mandé, 94160, France
Chu de La Reunion
Saint-Pierre, 97448, France
Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
SaintHerblain, 44805, France
Chu Nantes Hopital Nord Laennec
SaintHerblain, 44805, France
Chu Tours Hopital Bretonneau Service Pneumologie
Tours, 37000, France
High Technology Hospital Medcenter Ltd
Batumi, 6000, Georgia
Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
Tbilisi, 0112, Georgia
Israel Georgian Medical Research Clinic Helsicore Ltd
Tbilisi, 0112, Georgia
Jsc German Hospital
Tbilisi, 0119, Georgia
Institute of Clinical Oncology Ltd
Tbilisi, 0159, Georgia
Jsc Evex Hospitals Tbilisi
Tbilisi, 0159, Georgia
Tim Tbilisi Institute of Medicine Ltd
Tbilisi, 0160, Georgia
Caucasus Medical Centre Ltd
Tbilisi, 0186, Georgia
Multiprofile Clinic Consilium Medulla Ltd
Tbilisi, 0186, Georgia
Oncology Research Center Ltd
Tbilisi, 0186, Georgia
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Universitatsklinikum Bonn
Bonn, 53127, Germany
Kliniken Der Stadt Koeln Ggmbh
Cologne, 51109, Germany
Uniklinikum Giessen Marburg
Giessen, 35392, Germany
Lungenclinic Grosshansdorf Gmbh
Grohansdorf, 22927, Germany
Ambulantes Krebszentrum Hamburg
Hamburg, 20251, Germany
Munchen Klinik Bogenhausen
Munich, 81925, Germany
Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
Rotenburg (Wümme), 27356, Germany
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Papardo
Messina, 98158, Italy
Aou San Luigi Gonzaga
Orbassano, 10043, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University Hospital
Hirosaki, Aomori, 036-8563, Japan
Nho Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa, Gunma, 337-0280, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Hyogo Medical University Hospital
Nishinomiyashi, Hyōgo, 663-8501, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Miyagi Cancer Center
Natorishi, Miyagi, 981-1293, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
National Hospital Organization Kinki Chuo Chest Medical Center
Sakai, Osaka, 591-8555, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Osaka Toneyama Medical Center
Toyonaka, Osaka, 560-8552, Japan
Jichi Medical University Hospital
Shimonotsuke, Tochigi, 329-0498, Japan
Dokkyo Medical University Hospital
Shimotsugagun, Tochigi, 321-0293, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
Nippon Medical School Hospital
Bunkyoku, Tokyo, 113-8603, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
Rijnstate
Arnhem, 6815 AD, Netherlands
Ziekenhuis St Jansdal
Harderwijk, 3844 DG, Netherlands
Stichting Zuyderland Medisch Centrum
Heerlen, 6419 PC, Netherlands
Isala Klinieken Zwolle
Zwolle, 8025 AB, Netherlands
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, 15-276, Poland
Centrum Terapii Wspoczesnej
Lodz, 90-338, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-510, Poland
Wielkopolskie Centrum Pulmonologii I Torakochirurgii
Poznan, 60-569, Poland
Przychodnia Med Polonia Sp Z Oo
Poznan, 60-693, Poland
Etg Zamosc
Zamość, 22-400, Poland
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045, Russia
State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic
Ufa, Bashkortostan Republic, 450054, Russia
State Budgetary Healthcare Institution Regional Oncology Dispensary Number
Magnitogorsk, Chelyabinsk Oblast, 455001, Russia
Vitamed Llc
Moscow, Moscow, 121309, Russia
State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia
Bih of Omsk Region Clinical Oncology Dispensary
Omsk, Omsk Oblast, 644013, Russia
State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
Samara, Samaraskaya Oblast', 443031, Russia
Llc Av Medical Group
Saint Petersburg, Sankt-Peterburg, 197082, Russia
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, 28644, South Korea
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'yeogsi, 42601, South Korea
The Catholic University of Korea Bucheon St Marys Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Cha Bundang Medical Center, Cha University
Gyeonggido, Gyeonggi-do, 13496, South Korea
The Catholic University of Korea, St Vincents Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Kyungpook National University Chilgok Hospital
Daegu, Gyeongsangbukdo, 41404, South Korea
The Catholic University of Korea, Eunpyeong St Marys Hospital
Eunpyeonggu, Seoul Teugbyeolsi, 03312, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Hospital Universitario Fundacion Alcorcon
Alcorcón, 28922, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Universitario Vall Dhebron
Barcelona, 08035, Spain
Hospital Universitari Quiron Dexeus
Barcelona, 8028, Spain
Hospital General Universitario de Elche
Elche, 3203, Spain
Ico Girona
Girona, 17007, Spain
Hospital Universitario de Jaen
Jaén, 23007, Spain
Complejo Hospitalario Universitario Insular Gran Canaria
Las Palmas, 35016, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Start Madrid Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Doce de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, 32005, Spain
Hospital Universitari Son Espases
Palma de Mallorca, 07120, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitario Nuestra Senora de Valme
Seville, 41014, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Hospital Universitari I Politecnic La Fe
Valencia, 46026, Spain
Changhua Christian Hospital
Changhua, 50006, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Taipei Tzu Chi Hospital
Taipei, 231405, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305, Taiwan
National Taiwan University Hospital Yunlin Branch
Yunlin, 640, Taiwan
Siriraj Hospital
Bangkok, 10700, Thailand
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, 90110, Thailand
Chulabhorn Research Institute
Lak Si, 10210, Thailand
Srinagarind Hospital (Khon Kaen University)
Muang, 40002, Thailand
Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
Muang, 50200, Thailand
Phramongkutklao Hospital
Ratchathewi, 10400, Thailand
Rajavithi Hospital
Ratchathewi, 10400, Thailand
Acibadem Adana Hospital
Adana, 01130, Turkey (Türkiye)
Baskent University Practice and Research Hospital Adana Medical Oncology Department
Adana, 1240, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 6520, Turkey (Türkiye)
Inonu Universitesi Tip Fakultesi
Battalgazi, 44280, Turkey (Türkiye)
Tr Trakya University Health Research and Application Center (Hospital)
Edirne, 22030, Turkey (Türkiye)
Iu C, Clinical Research Excellence Application and Research Center
Istanbul, 34098, Turkey (Türkiye)
Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul, 34722, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Necmettin Erbakan University Selcuklu Faculty of Medicine
Meram, 42090, Turkey (Türkiye)
Mersin City Hospital
Mersin City Hospital, 33240, Turkey (Türkiye)
Medical Center of Limited Liability Company Mriya Med Service
Kryvyi Rih, 50000, Ukraine
Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
Uzhhorod, 88000, Ukraine
Zakarpatska Regional Clinical Oncological Center
Uzhhorod, 88011, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2021
First Posted
February 10, 2021
Study Start
May 24, 2021
Primary Completion
May 30, 2025
Study Completion
March 18, 2026
Last Updated
May 12, 2026
Results First Posted
May 12, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.