A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
NCT ID: NCT04746924
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
662 participants
INTERVENTIONAL
2021-06-08
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A: Tislelizumab plus Ociperlimab
Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Arm B: Pembrolizumab plus Placebo
Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Pembrolizumab
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
Placebo
Placebo infusions will consist of a sterile, normal saline solution.
Arm C: Tislelizumab plus Placebo
Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Placebo
Placebo infusions will consist of a sterile, normal saline solution.
Interventions
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Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Pembrolizumab
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
Placebo
Placebo infusions will consist of a sterile, normal saline solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No prior systemic treatment for metastatic NSCLC.
3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
4. Tumors with PD-L1 expressed in ≥ 50% tumor cells.
5. At least 1 measurable lesion as defined per RECIST v1.1.
6. ECOG Performance Status ≤ 1.
Exclusion Criteria
2. 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.
3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Active autoimmune diseases or history of autoimmune diseases that may relapse.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Locations
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Providence Medical Foundation St Jude Heritage Healthcare
Fullerton, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
Ocala, Florida, United States
Advent Health Cancer Institute
Orlando, Florida, United States
Goshen Center For Cancer Care
Goshen, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University Medical Center New Orleans West Jefferson Medical Center
New Orleans, Louisiana, United States
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Centro Medical Austral
Buenos Aires, , Argentina
Centro Para La Atencion Del Paciente Oncologico (Caipo)
San Miguel de Tucumán, , Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Northern Cancer Institute
St Leonards, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Mater Cancer Care Centre
South Brisbane, Queensland, Australia
John Flynn Private Hospital
Tugun, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Ballarat Health Services
Ballarat, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Western Health Sunshine Hospital
St Albans, Victoria, Australia
St John of God, Murdoch
Murdoch, Western Australia, Australia
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, , Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, , Brazil
Centro de Pesquisas Oncologicas Cepon
Florianópolis, , Brazil
Cancer Institute of Ceara
Fortaleza, , Brazil
Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, , Brazil
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Shenzhen Peoples Hospital
Shenzhen, Guangdong, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
Changzhou, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Chest Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
The Affiliated Hospital of Qingdao University Branch Laoshan
Qingdao, Shandong, China
Weifang Peoples Hospital
Weifang, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang, China
Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
Bayonne, , France
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, , France
Hopital de La Croix Rousse
Lyon, , France
Hopital Louis Pradel
Lyon, , France
Icm Val Daurelle Oncologie Medicale
Montpellier, , France
Polyclinique de Gentilly
Nancy, , France
Hopital Cochin
Paris, , France
Chu Hopital Lyon Sud
PierreBenite, , France
Hia Begin
Saint-Mandé, , France
Chu de La Reunion
Saint-Pierre, , France
Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
SaintHerblain, , France
Chu Nantes Hopital Nord Laennec
SaintHerblain, , France
Chu Tours Hopital Bretonneau Service Pneumologie
Tours, , France
High Technology Hospital Medcenter Ltd
Batumi, , Georgia
Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
Tbilisi, , Georgia
Israel Georgian Medical Research Clinic Helsicore Ltd
Tbilisi, , Georgia
Jsc German Hospital
Tbilisi, , Georgia
Institute of Clinical Oncology Ltd
Tbilisi, , Georgia
Jsc Evex Hospitals Tbilisi
Tbilisi, , Georgia
Tim Tbilisi Institute of Medicine Ltd
Tbilisi, , Georgia
Caucasus Medical Centre Ltd
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla Ltd
Tbilisi, , Georgia
Oncology Research Center Ltd
Tbilisi, , Georgia
Universitaetsklinikum Aachen
Aachen, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Kliniken Der Stadt Koeln Ggmbh
Cologne, , Germany
Uniklinikum Giessen Marburg
Giessen, , Germany
Lungenclinic Grosshansdorf Gmbh
Grohansdorf, , Germany
Ambulantes Krebszentrum Hamburg
Hamburg, , Germany
Munchen Klinik Bogenhausen
Munich, , Germany
Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
Rotenburg (Wümme), , Germany
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna, , Italy
Azienda Ospedaliera Papardo
Messina, , Italy
Aou San Luigi Gonzaga
Orbassano, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Nho Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa, Gunma, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Hyogo Medical University Hospital
Nishinomiyashi, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Miyagi Cancer Center
Natorishi, Miyagi, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
National Hospital Organization Kinki Chuo Chest Medical Center
Sakai, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Osaka Toneyama Medical Center
Toyonaka, Osaka, Japan
Jichi Medical University Hospital
Shimonotsuke, Tochigi, Japan
Dokkyo Medical University Hospital
Shimotsugagun, Tochigi, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
Nippon Medical School Hospital
Bunkyoku, Tokyo, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Meander Medisch Centrum
Amersfoort, , Netherlands
Rijnstate
Arnhem, , Netherlands
Ziekenhuis St Jansdal
Harderwijk, , Netherlands
Stichting Zuyderland Medisch Centrum
Heerlen, , Netherlands
Isala Klinieken Zwolle
Zwolle, , Netherlands
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, , Poland
Centrum Terapii Wspoczesnej
Lodz, , Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, , Poland
Wielkopolskie Centrum Pulmonologii I Torakochirurgii
Poznan, , Poland
Przychodnia Med Polonia Sp Z Oo
Poznan, , Poland
Etg Zamosc
Zamość, , Poland
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, Russia
State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic
Ufa, Bashkortostan Republic, Russia
State Budgetary Healthcare Institution Regional Oncology Dispensary Number
Magnitogorsk, Chelyabinsk Oblast, Russia
Vitamed Llc
Moscow, Moscow, Russia
State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Bih of Omsk Region Clinical Oncology Dispensary
Omsk, Omsk Oblast, Russia
State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
Samara, Samaraskaya Oblast', Russia
Llc Av Medical Group
Saint Petersburg, Sankt-Peterburg, Russia
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, South Korea
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'yeogsi, South Korea
The Catholic University of Korea Bucheon St Marys Hospital
Bucheon-si, Gyeonggi-do, South Korea
Cha Bundang Medical Center, Cha University
Gyeonggido, Gyeonggi-do, South Korea
The Catholic University of Korea, St Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Kyungpook National University Chilgok Hospital
Daegu, Gyeongsangbukdo, South Korea
The Catholic University of Korea, Eunpyeong St Marys Hospital
Eunpyeonggu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Fundacion Alcorcon
Alcorcón, , Spain
Hospital Del Mar
Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario Vall Dhebron
Barcelona, , Spain
Hospital Universitari Quiron Dexeus
Barcelona, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Ico Girona
Girona, , Spain
Hospital Universitario de Jaen
Jaén, , Spain
Complejo Hospitalario Universitario Insular Gran Canaria
Las Palmas, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Start Madrid Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Doce de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario Virgen de La Victoria
Málaga, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Complexo Hospitalario Universitario de Ourense
Ourense, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitario Nuestra Senora de Valme
Seville, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Hospital Universitari I Politecnic La Fe
Valencia, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Taipei Tzu Chi Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
National Taiwan University Hospital Yunlin Branch
Yunlin, , Taiwan
Siriraj Hospital
Bangkok, , Thailand
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, , Thailand
Chulabhorn Research Institute
Lak Si, , Thailand
Srinagarind Hospital (Khon Kaen University)
Muang, , Thailand
Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
Muang, , Thailand
Phramongkutklao Hospital
Ratchathewi, , Thailand
Rajavithi Hospital
Ratchathewi, , Thailand
Acibadem Adana Hospital
Adana, , Turkey (Türkiye)
Baskent University Practice and Research Hospital Adana Medical Oncology Department
Adana, , Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, , Turkey (Türkiye)
Inonu Universitesi Tip Fakultesi
Battalgazi, , Turkey (Türkiye)
Tr Trakya University Health Research and Application Center (Hospital)
Edirne, , Turkey (Türkiye)
Iu C, Clinical Research Excellence Application and Research Center
Istanbul, , Turkey (Türkiye)
Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
Necmettin Erbakan University Selcuklu Faculty of Medicine
Meram, , Turkey (Türkiye)
Mersin City Hospital
Mersin City Hospital, , Turkey (Türkiye)
Medical Center of Limited Liability Company Mriya Med Service
Kryvyi Rih, , Ukraine
Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
Uzhhorod, , Ukraine
Zakarpatska Regional Clinical Oncological Center
Uzhhorod, , Ukraine
Countries
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Other Identifiers
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BGB-A317-A1217-302
Identifier Type: OTHER
Identifier Source: secondary_id
CTR20211476/CTR20211464
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004985-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AdvanTIG-302
Identifier Type: -
Identifier Source: org_study_id
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