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

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).

Study Overview

• Status: Terminated
• Conditions: NSCLC; Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab; Drug: Ociperlimab; Drug: Pembrolizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 669
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1409
    • Centro Medical Austral
  • San Miguel de Tucumán, Argentina, 4000
    • Centro Para La Atencion Del Paciente Oncologico (Caipo)
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Northern Cancer Institute
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Pindara Private Hospital
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Cancer Care Centre
    • Tugun, Queensland, Australia, 4224
      • John Flynn Private Hospital
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Health Services
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • St Albans, Victoria, Australia, 3021
      • Western Health Sunshine Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • St John of God, Murdoch
• Brazil
  • Brasília, Brazil, 70390140
    • Instituto Dor de Pesquisa E Ensino Distrito Federal
  • Cachoeiro de Itapemirim, Brazil, 29308-020
    • Hospital Evangelico de Cachoeiro de Itapemirim
  • Florianópolis, Brazil, 88034-000
    • Centro de Pesquisas Oncologicas Cepon
  • Fortaleza, Brazil, 60430-235
    • Cancer Institute of Ceara
  • Santo André, Brazil, 09060-650
    • Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
  • São José do Rio Preto, Brazil, 15090-000
    • Fundação Faculdade Regional de Medicina de São José do Rio Preto
• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230000
      • Anhui Provincial Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China, 100020
      • Beijing Chao Yang Hospital
    • Beijing, Beijing Municipality, China, 101149
      • Beijing Chest Hospital, Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing Cancer Hospital
    • Chongqing, Chongqing Municipality, China, 400042
      • Daping Hospital, Third Military Medical University
    • Chongqing, Chongqing Municipality, China, 400038
      • The First Affiliated Hospital of Army Military Medical University
    • Chongqing, Chongqing Municipality, China, 404000
      • Chongqing University Three Gorges Central Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    • Shantou, Guangdong, China, 515031
      • Cancer Hospital of Shantou University Medical College
    • Shenzhen, Guangdong, China, 518020
      • Shenzhen Peoples Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The Peoples Hospital of Guangxi Zhuang Autonomous Region
    • Nanning, Guangxi, China, 530021
      • The Tumor Hospital Affiliated to Guangxi Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • the First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430022
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Chest Hospital
    • Nanjing, Jiangsu, China, 210009
      • Nanjing First Hospital
    • Suzhou, Jiangsu, China, 215000
      • The Second Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University Branch Shizi
    • Xuzhou, Jiangsu, China, 221000
      • Xuzhou Central Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xian Jiaotong University
  • Shandong
    • Qingdao, Shandong, China, 266000
      • The Affiliated Hospital of Qingdao University Branch Laoshan
    • Weifang, Shandong, China, 261000
      • Weifang Peoples Hospital
    • Yantai, Shandong, China, 264000
      • Yantai Yuhuangding Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai Chest Hospital
    • Shanghai, Shanghai Municipality, China, 200032
      • Affiliated Zhongshan Hospital of Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital and Institute
    • Nanchong, Sichuan, China, 637000
      • Affiliated Hospital of North Sichuan Medical College
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830000
      • Affiliated Cancer Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China, 315010
      • The First Affiliated Hospital of Ningbo University
    • Taizhou, Zhejiang, China, 317000
      • Taizhou Hospital of Zhejiang
    • Yiwu, Zhejiang, China, 322000
      • The Fourth Affiliated Hospital Zhejiang University School of Medicine
• France
  • Bayonne, France, 64100
    • Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
  • Bordeaux, France, 33076
    • Centre de Lutte Contre Le Cancer Institut Bergonie
  • Lyon, France, 69317
    • Hôpital de La Croix Rousse
  • Lyon, France, 69500
    • Hôpital Louis Pradel
  • Montpellier, France, 24298
    • Icm Val Daurelle Oncologie Medicale
  • Nancy, France, 54100
    • Polyclinique de Gentilly
  • Paris, France, 75014
    • Hopital Cochin
  • PierreBenite, France, 69495
    • Chu Hopital Lyon Sud
  • Saint-Mandé, France, 94160
    • Hia Begin
  • Saint-Pierre, France, 97448
    • CHU de la réunion
  • SaintHerblain, France, 44805
    • Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
  • SaintHerblain, France, 44805
    • Chu Nantes Hopital Nord Laennec
  • Tours, France, 37000
    • Chu Tours Hopital Bretonneau Service Pneumologie
• Georgia
  • Batumi, Georgia, 6000
    • High Technology Hospital MedCenter Ltd
  • Tbilisi, Georgia, 0186
    • Multiprofile Clinic Consilium Medulla LTD
  • Tbilisi, Georgia, 0159
    • Institute of Clinical Oncology Ltd
  • Tbilisi, Georgia, 0112
    • Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
  • Tbilisi, Georgia, 0112
    • Israel Georgian Medical Research Clinic Helsicore Ltd
  • Tbilisi, Georgia, 0119
    • Jsc German Hospital
  • Tbilisi, Georgia, 0159
    • Jsc Evex Hospitals Tbilisi
  • Tbilisi, Georgia, 0160
    • Tim Tbilisi Institute of Medicine Ltd
  • Tbilisi, Georgia, 0186
    • Caucasus Medical Centre Ltd
  • Tbilisi, Georgia, 0186
    • Oncology Research Center Ltd
• Germany
  • Aachen, Germany, 52074
    • Universitaetsklinikum Aachen
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Cologne, Germany, 51109
    • Kliniken Der Stadt Koeln Ggmbh
  • Giessen, Germany, 35392
    • Uniklinikum Giessen Marburg
  • Grohansdorf, Germany, 22927
    • LungenClinic Grosshansdorf GmbH
  • Hamburg, Germany, 20251
    • Ambulantes Krebszentrum Hamburg
  • Munich, Germany, 81925
    • Munchen Klinik Bogenhausen
  • Rotenburg (Wümme), Germany, 27356
    • Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
  • Messina, Italy, 98158
    • Azienda Ospedaliera Papardo
  • Orbassano, Italy, 10043
    • AOU San Luigi Gonzaga
• Japan
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Nagoya University Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Hirosaki University Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Nho Shikoku Cancer Center
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Gunma
    • Shibukawa, Gunma, Japan, 337-0280
      • National Hospital Organization Shibukawa Medical Center
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0017
      • Kobe University Hospital
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
    • Nishinomiyashi, Hyōgo, Japan, 663-8501
      • Hyogo Medical University Hospital
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Kanazawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa cancer center
  • Miyagi
    • Natorishi, Miyagi, Japan, 981-1293
      • Miyagi Cancer Center
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Okayama University Hospital
  • Osaka
    • Hirakata, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital
    • Sakai, Osaka, Japan, 591-8555
      • National Hospital Organization Kinki Chuo Chest Medical Center
    • Sayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
    • Toyonaka, Osaka, Japan, 560-8552
      • Osaka Toneyama Medical Center
  • Tochigi
    • Shimonotsuke, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
    • Shimotsugagun, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital
    • Utsunomiya, Tochigi, Japan, 320-0834
      • Tochigi Cancer Center
  • Tokyo
    • Bunkyoku, Tokyo, Japan, 113-8603
      • Nippon Medical School Hospital
    • Kotoku, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of Jfcr
• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • Meander Medisch Centrum
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate
  • Harderwijk, Netherlands, 3844 DG
    • Ziekenhuis St Jansdal
  • Heerlen, Netherlands, 6419 PC
    • Stichting Zuyderland Medisch Centrum
  • Zwolle, Netherlands, 8025 AB
    • Isala Klinieken Zwolle
• Poland
  • Bialystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny W Bialymstoku
  • Lodz, Poland, 93-510
    • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspoczesnej
  • Poznan, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii
  • Poznan, Poland, 60-693
    • Przychodnia Med Polonia Sp Z Oo
  • Zamość, Poland, 22-400
    • ETG Zamosc
• Russia
  • Arkhangelskaya oblast
    • Arkhangelsk, Arkhangelskaya oblast, Russia, 163045
      • Arkhangelsk Regional Clinical Oncological Dispensary
  • Bashkortostan Republic
    • Ufa, Bashkortostan Republic, Russia, 450054
      • State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic
  • Chelyabinsk Oblast
    • Magnitogorsk, Chelyabinsk Oblast, Russia, 455001
      • State Budgetary Healthcare Institution Regional Oncology Dispensary Number
  • Moscow
    • Moscow, Moscow, Russia, 121309
      • VitaMed LLC
  • Nizhny Novgorod Oblast
    • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603081
      • State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
  • Omsk Oblast
    • Omsk, Omsk Oblast, Russia, 644013
      • Bih of Omsk Region Clinical Oncology Dispensary
  • Samaraskaya Oblast'
    • Samara, Samaraskaya Oblast', Russia, 443031
      • State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197082
      • Llc Av Medical Group
• South Korea
  • Chungcheongbukdo
    • Cheongju-si, Chungcheongbukdo, South Korea, 28644
      • Chungbuk National University Hospital
  • Daegu Gwang'yeogsi
    • Dalseogu, Daegu Gwang'yeogsi, South Korea, 42601
      • Keimyung University Dongsan Hospital
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea, 14647
      • The Catholic University of Korea Bucheon St Marys Hospital
    • Gyeonggido, Gyeonggi-do, South Korea, 13496
      • Cha Bundang Medical Center, Cha University
    • Suwon, Gyeonggi-do, South Korea, 16247
      • The Catholic University of Korea, St Vincents Hospital
  • Gyeongsangbukdo
    • Daegu, Gyeongsangbukdo, South Korea, 41404
      • Kyungpook National University Chilgok Hospital
  • Seoul Teugbyeolsi
    • Eunpyeonggu, Seoul Teugbyeolsi, South Korea, 03312
      • The Catholic University of Korea, Eunpyeong St Marys Hospital
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Severance Hospital Yonsei University Health System
• Spain
  • Alcorcón, Spain, 28922
    • Hospital Universitario Fundacion Alcorcon
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08025
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall Dhebron
  • Barcelona, Spain, 8028
    • Hospital Universitari Quiron Dexeus
  • Elche, Spain, 3203
    • Hospital General Universitario de Elche
  • Girona, Spain, 17007
    • ICO Girona
  • Jaén, Spain, 23007
    • Hospital Universitario de Jaen
  • Las Palmas, Spain, 35016
    • Complejo Hospitalario Universitario Insular Gran Canaria
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28041
    • Hospital Universitario Doce de Octubre
  • Madrid, Spain, 28040
    • Start Madrid Fundacion Jimenez Diaz
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Murcia, Spain, 30008
    • Hospital General Universitario Morales Meseguer
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Ourense, Spain, 32005
    • Complexo Hospitalario Universitario de Ourense
  • Palma de Mallorca, Spain, 07120
    • Hospital Universitari Son Espases
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41014
    • Hospital Universitario Nuestra Señora de Valme
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 231405
    • Taipei Tzu Chi Hospital
  • Taoyuan, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital
  • Yunlin, Taiwan, 640
    • National Taiwan University Hospital Yunlin Branch
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Hat Yai, Thailand, 90110
    • Songklanagarind Hospital (Prince of Songkhla University)
  • Lak Si, Thailand, 10210
    • Chulabhorn Research Institute
  • Muang, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
  • Muang, Thailand, 40002
    • Srinagarind Hospital (Khon Kaen University)
  • Ratchathewi, Thailand, 10400
    • Phramongkutklao Hospital
  • Ratchathewi, Thailand, 10400
    • Rajavithi Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01130
    • Acibadem Adana Hospital
  • Adana, Turkey (Türkiye), 1240
    • Baskent University Practice and Research Hospital Adana Medical Oncology Department
  • Ankara, Turkey (Türkiye), 6520
    • Memorial Ankara Hospital
  • Ankara, Turkey (Türkiye), 06200
    • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
  • Battalgazi, Turkey (Türkiye), 44280
    • Inonu Universitesi Tip Fakultesi
  • Edirne, Turkey (Türkiye), 22030
    • Tr Trakya University Health Research and Application Center (Hospital)
  • Istanbul, Turkey (Türkiye), 34098
    • Iu C, Clinical Research Excellence Application and Research Center
  • Istanbul, Turkey (Türkiye), 34722
    • Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
  • Izmir, Turkey (Türkiye), 35100
    • Ege University Medical Faculty
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Universitesi Tip Fakultesi
  • Meram, Turkey (Türkiye), 42090
    • Necmettin Erbakan University Selcuklu Faculty of Medicine
  • Mersin City Hospital, Turkey (Türkiye), 33240
    • Mersin City Hospital
• Ukraine
  • Kryvyi Rih, Ukraine, 50000
    • Medical Center of Limited Liability Company Mriya Med Service
  • Uzhhorod, Ukraine, 88000
    • Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
  • Uzhhorod, Ukraine, 88011
    • Zakarpatska Regional Clinical Oncological Center
• United States
  • California
    • Fullerton, California, United States, 92835
      • Providence Medical Foundation St Jude Heritage Healthcare
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
    • Orlando, Florida, United States, 32804
      • Advent Health Cancer Institute
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans West Jefferson Medical Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Metro Minnesota Community Oncology Research Consortium (MMCORC)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. 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.
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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Key Exclusion Criteria:

1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Ociperlimab plus Tislelizumab; Participants 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.	Drug: Tislelizumab; Tislelizumab is a monoclonal antibody formulated for intravenous injection.; Other Names: BGB-A317; Drug: Ociperlimab; Ociperlimab is a monoclonal antibody formulated for intravenous injection.; Other Names: BGB-A1217
Active Comparator: Arm B: Pembrolizumab plus Placebo; Participants received pembrolizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.	Drug: Pembrolizumab; Pembrolizumab is a monoclonal antibody formulated for intravenous injection.; Other Names: KEYTRUDA; Drug: Placebo; Placebo infusions will consist of a sterile, normal saline solution.
Placebo Comparator: Arm C: Tislelizumab plus Placebo; Participants received tislelizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.	Drug: Tislelizumab; Tislelizumab is a monoclonal antibody formulated for intravenous injection.; Other Names: BGB-A317; Drug: Placebo; Placebo infusions will consist of a sterile, normal saline solution.
Experimental: Safety Run-In Substudy; Japanese 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.	Drug: Tislelizumab; Tislelizumab is a monoclonal antibody formulated for intravenous injection.; Other Names: BGB-A317; Drug: Ociperlimab; Ociperlimab is a monoclonal antibody formulated for intravenous injection.; Other Names: BGB-A1217

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator	PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. PFS was a pre-specified secondary endpoint for Arms A and B only. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of existing non-target lesions, or new lesions.	Up to 45.0 months
Progression-free Survival (PFS) for Safety Run-In Substudy As Assessed By the Investigator	PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method.	Up to 38.9 months
Overall Response Rate (ORR) for Arm A Versus Arm B As Assessed By the Investigator	ORR is defined as the percentage of participants with a documented, confirmed complete response or partial response per RECIST v1.1. ORR was a pre-specified secondary endpoint for Arms A and B only. Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions.	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	ORR is defined as the percentage of participants with a documented, confirmed complete response or partial response per RECIST v1.1.	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	DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method. DOR was a pre-specified secondary endpoint for Arms A and B only.	Up to 45.0 months
Duration Of Response (DOR) for Safety Run-In Substudy As Assessed By the Investigator	DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method.	Up to 38.9 months
Change From Baseline in Global Health Status (GHS)/Quality of Life (QoL), Physical Functioning, and Pain Scores: European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) in Arms A and B	The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 GHS scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health QoL questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. Lower scores in symptom scales indicate better quality of life. Included in this outcome measure were evaluation of GHS/QoL, physical functioning, and fatigue. This was a pre-specified secondary endpoint for Arms A and B only.	Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
Change From Baseline in EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) Index Score, Dyspnea, Coughing, Hemoptysis, Pain in Chest, Pain in Arms/Shoulders, and Peripheral Neuropathy Scores in Arms A and B	The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. The symptom index scale was calculated by taking the mean of all symptom scale scores, and ranges from 0 to 100. Lower scores indicate an improvement in symptoms. This was a pre-specified secondary endpoint for Arms A and B only.	Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
Change From Baseline in European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Visual Analog Scale in Arms A and B	The EQ-5D-5L comprises a descriptive module that includes five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a Visual Analog Scale (VAS). The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes. This was a pre-specified secondary endpoint for Arms A and B only.	Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
Time To Deterioration (TTD) in Arms A and B Based on QLQ-LC13 Index Score, Cough, Chest Pain, Dyspnea, Hemoptysis, Arm or Shoulder Pain, and Peripheral Neuropathy	TTD is defined as the time from randomization to the first occurrence of worsening scores of ≥ 10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause. TTD was estimated using the Kaplan-Meier method. TTD was a pre-specified secondary endpoint for Arms A and B only.	Up to 45.0 months
Time To Deterioration (TTD) in Arms A and B Based on QLQ-C30 GHS/QoL Score, Physical Functioning, and Fatigue	TTD is defined as the time from randomization to the first occurrence of worsening scores of ≥10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause. TTD was estimated using the Kaplan-Meier method. TTD was a pre-specified secondary endpoint for Arms A and B only.	Up to 45.0 months
Number Of Participants Experiencing Adverse Events (AEs) in Arm A	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. An 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. This was a pre-specified secondary endpoint for Arm A only.	From first dose of study drug up to 30 days after last dose (or 90 days for immune-mediated AEs); maximum treatment duration was 45.0 months
Safety Run-In Substudy: Participants With Anti-Drug Antibodies		Up to 38.9 months

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Principal Investigator: Mark Socinski, Advent Health Orlando; Principal Investigator: Shun Lu, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): March 18, 2026

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pembrolizumab; Metastatic; Unresectable; Locally Advanced; Tislelizumab; BGB-A317; Ociperlimab; BGB-A1217; Anti-TIGIT
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; pembrolizumab; tislelizumab
• Other Study ID Numbers: AdvanTIG-302; BGB-A317-A1217-302 (Other Identifier: BeiGene); CTR20211476/CTR20211464 (Other Identifier: ChinaDrugTrials); 2020-004985-21 (EudraCT Number); 2023-507317-10-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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