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ACTIVE NOT RECRUITING
NCT04746924
PHASE3

A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

Sponsor: BeiGene

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

662

Start Date

2021-06-08

Completion Date

2026-03-31

Last Updated

2025-06-24

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

Tislelizumab is a monoclonal antibody formulated for intravenous injection.

DRUG

Ociperlimab

Ociperlimab is a monoclonal antibody formulated for intravenous injection.

DRUG

Pembrolizumab

Pembrolizumab is a monoclonal antibody formulated for intravenous injection.

DRUG

Placebo

Placebo infusions will consist of a sterile, normal saline solution.

Locations (218)

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