AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3NCT04746924

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

A Phase 3 study testing Tislelizumab, Ociperlimab and Pembrolizumab in people with Non-small Cell Lung Cancer and NSCLC, run by BeiGene at 218 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer, NSCLC
What is being tested?
Tislelizumab, Ociperlimab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
669 participants
Where
218 sitesin 19 countries
Study dates
24 May 2021to 18 Mar 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

218 sites in 19 countries.

218 sites in 19 countries

China52 sites

  • Beijing Chao Yang Hospital

    Beijing, Beijing Municipality, 100020

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng

    Changzhou, Jiangsu, 213003

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • The First Affiliated Hospital of Army Military Medical University

    Chongqing, Chongqing Municipality, 400038

  • Daping Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • Chongqing University Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404000

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510030

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210009

  • Nanjing Chest Hospital

    Nanjing, Jiangsu, 210029

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

  • The Affiliated Hospital of Qingdao University Branch Laoshan

    Qingdao, Shandong, 266000

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Shenzhen Peoples Hospital

    Shenzhen, Guangdong, 518020

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

  • The First Affiliated Hospital of Soochow University Branch Shizi

    Suzhou, Jiangsu, 215006

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Taizhou Hospital of Zhejiang

    Taizhou, Zhejiang, 317000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • The Fourth Affiliated Hospital Zhejiang University School of Medicine

    Yiwu, Zhejiang, 322000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Spain24 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, 28922

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035

  • Hospital Universitari Quiron Dexeus

    Barcelona, 8028

  • Hospital General Universitario de Elche

    Elche, 3203

  • Ico Girona

    Girona, 17007

  • Hospital Universitario de Jaen

    Jaén, 23007

  • Complejo Hospitalario Universitario Insular Gran Canaria

    Las Palmas, 35016

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario Doce de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Complexo Hospitalario Universitario de Ourense

    Ourense, 32005

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitario Nuestra Senora de Valme

    Seville, 41014

  • Hospital Arnau de Vilanova

    Valencia, 46015

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Japan23 sites

  • Nippon Medical School Hospital

    Bunkyoku, Tokyo, 113-8603

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

  • Hirosaki University Hospital

    Hirosaki, Aomori, 036-8563

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo, 135-8550

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Nho Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Miyagi Cancer Center

    Natorishi, Miyagi, 981-1293

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Hyogo Medical University Hospital

    Nishinomiyashi, Hyōgo, 663-8501

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • National Hospital Organization Kinki Chuo Chest Medical Center

    Sakai, Osaka, 591-8555

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa, Gunma, 337-0280

  • Jichi Medical University Hospital

    Shimonotsuke, Tochigi, 329-0498

  • Dokkyo Medical University Hospital

    Shimotsugagun, Tochigi, 321-0293

  • Osaka Toneyama Medical Center

    Toyonaka, Osaka, 560-8552

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

France13 sites

  • Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie

    Bayonne, 64100

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076

  • Hopital de La Croix Rousse

    Lyon, 69317

  • Hopital Louis Pradel

    Lyon, 69500

  • Icm Val Daurelle Oncologie Medicale

    Montpellier, 24298

  • Polyclinique de Gentilly

    Nancy, 54100

  • Hopital Cochin

    Paris, 75014

  • Chu Hopital Lyon Sud

    PierreBenite, 69495

  • Hia Begin

    Saint-Mandé, 94160

  • Chu de La Reunion

    Saint-Pierre, 97448

  • Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau

    SaintHerblain, 44805

  • Chu Nantes Hopital Nord Laennec

    SaintHerblain, 44805

  • Chu Tours Hopital Bretonneau Service Pneumologie

    Tours, 37000

Other trials in France

Australia12 sites

  • Ballarat Health Services

    Ballarat, Victoria, 3350

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Monash Health

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • St John of God, Murdoch

    Murdoch, Western Australia, 6150

  • Mater Cancer Care Centre

    South Brisbane, Queensland, 4101

  • Western Health Sunshine Hospital

    St Albans, Victoria, 3021

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

  • John Flynn Private Hospital

    Tugun, Queensland, 4224

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

Turkey (Türkiye)12 sites

  • Acibadem Adana Hospital

    Adana, 01130

  • Baskent University Practice and Research Hospital Adana Medical Oncology Department

    Adana, 1240

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200

  • Memorial Ankara Hospital

    Ankara, 6520

  • Inonu Universitesi Tip Fakultesi

    Battalgazi, 44280

  • Tr Trakya University Health Research and Application Center (Hospital)

    Edirne, 22030

  • Iu C, Clinical Research Excellence Application and Research Center

    Istanbul, 34098

  • Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital

    Istanbul, 34722

  • Ege University Medical Faculty

    Izmir, 35100

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Necmettin Erbakan University Selcuklu Faculty of Medicine

    Meram, 42090

  • Mersin City Hospital

    Mersin City Hospital, 33240

Other trials in Turkey (Türkiye)

Georgia10 sites

  • High Technology Hospital Medcenter Ltd

    Batumi, 6000

  • Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd

    Tbilisi, 0112

  • Israel Georgian Medical Research Clinic Helsicore Ltd

    Tbilisi, 0112

  • Jsc German Hospital

    Tbilisi, 0119

  • Institute of Clinical Oncology Ltd

    Tbilisi, 0159

  • Jsc Evex Hospitals Tbilisi

    Tbilisi, 0159

  • Tim Tbilisi Institute of Medicine Ltd

    Tbilisi, 0160

  • Caucasus Medical Centre Ltd

    Tbilisi, 0186

  • Multiprofile Clinic Consilium Medulla Ltd

    Tbilisi, 0186

  • Oncology Research Center Ltd

    Tbilisi, 0186

Other trials in Georgia

United States9 sites

  • Providence Medical Foundation St Jude Heritage Healthcare

    Fullerton, California, 92835

  • Goshen Center For Cancer Care

    Goshen, Indiana, 46526

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • University Medical Center New Orleans West Jefferson Medical Center

    New Orleans, Louisiana, 70112

  • Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala

    Ocala, Florida, 34474

  • Advent Health Cancer Institute

    Orlando, Florida, 32804

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Metro Minnesota Community Oncology Research Consortium (Mmcorc)

    Saint Paul, Minnesota, 55101

Other trials in United States

Germany8 sites

  • Universitaetsklinikum Aachen

    Aachen, 52074

  • Universitatsklinikum Bonn

    Bonn, 53127

  • Kliniken Der Stadt Koeln Ggmbh

    Cologne, 51109

  • Uniklinikum Giessen Marburg

    Giessen, 35392

  • Lungenclinic Grosshansdorf Gmbh

    Grohansdorf, 22927

  • Ambulantes Krebszentrum Hamburg

    Hamburg, 20251

  • Munchen Klinik Bogenhausen

    Munich, 81925

  • Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh

    Rotenburg (Wümme), 27356

Other trials in Germany

Russia8 sites

  • Arkhangelsk Regional Clinical Oncological Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • State Budgetary Healthcare Institution Regional Oncology Dispensary Number

    Magnitogorsk, Chelyabinsk Oblast, 455001

  • Vitamed Llc

    Moscow, Moscow, 121309

  • State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603081

  • Bih of Omsk Region Clinical Oncology Dispensary

    Omsk, Omsk Oblast, 644013

  • Llc Av Medical Group

    Saint Petersburg, Sankt-Peterburg, 197082

  • State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary

    Samara, Samaraskaya Oblast', 443031

  • State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic

    Ufa, Bashkortostan Republic, 450054

Other trials in Russia

South Korea8 sites

  • The Catholic University of Korea Bucheon St Marys Hospital

    Bucheon-si, Gyeonggi-do, 14647

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbukdo, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, Gyeongsangbukdo, 41404

  • Keimyung University Dongsan Hospital

    Dalseogu, Daegu Gwang'yeogsi, 42601

  • The Catholic University of Korea, Eunpyeong St Marys Hospital

    Eunpyeonggu, Seoul Teugbyeolsi, 03312

  • Cha Bundang Medical Center, Cha University

    Gyeonggido, Gyeonggi-do, 13496

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722

  • The Catholic University of Korea, St Vincents Hospital

    Suwon, Gyeonggi-do, 16247

Other trials in South Korea

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Taipei Tzu Chi Hospital

    Taipei, 231405

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305

  • National Taiwan University Hospital Yunlin Branch

    Yunlin, 640

Other trials in Taiwan

Thailand7 sites

  • Siriraj Hospital

    Bangkok, 10700

  • Songklanagarind Hospital (Prince of Songkhla University)

    Hat Yai, 90110

  • Chulabhorn Research Institute

    Lak Si, 10210

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002

  • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

    Muang, 50200

  • Phramongkutklao Hospital

    Ratchathewi, 10400

  • Rajavithi Hospital

    Ratchathewi, 10400

Other trials in Thailand

Brazil6 sites

  • Instituto Dor de Pesquisa E Ensino Distrito Federal

    Brasília, 70390140

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, 29308-020

  • Centro de Pesquisas Oncologicas Cepon

    Florianópolis, 88034-000

  • Cancer Institute of Ceara

    Fortaleza, 60430-235

  • Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo André, 09060-650

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000

Other trials in Brazil

Poland6 sites

  • Uniwersytecki Szpital Kliniczny W Bialymstoku

    Bialystok, 15-276

  • Centrum Terapii Wspoczesnej

    Lodz, 90-338

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-510

  • Wielkopolskie Centrum Pulmonologii I Torakochirurgii

    Poznan, 60-569

  • Przychodnia Med Polonia Sp Z Oo

    Poznan, 60-693

  • Etg Zamosc

    Zamość, 22-400

Other trials in Poland

Netherlands5 sites

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • Rijnstate

    Arnhem, 6815 AD

  • Ziekenhuis St Jansdal

    Harderwijk, 3844 DG

  • Stichting Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • Isala Klinieken Zwolle

    Zwolle, 8025 AB

Other trials in Netherlands

Italy3 sites

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Papardo

    Messina, 98158

  • Aou San Luigi Gonzaga

    Orbassano, 10043

Other trials in Italy

Ukraine3 sites

  • Medical Center of Limited Liability Company Mriya Med Service

    Kryvyi Rih, 50000

  • Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council

    Uzhhorod, 88000

  • Zakarpatska Regional Clinical Oncological Center

    Uzhhorod, 88011

Other trials in Ukraine

Argentina2 sites

  • Centro Medical Austral

    Buenos Aires, 1409

  • Centro Para La Atencion Del Paciente Oncologico (Caipo)

    San Miguel de Tucumán, 4000

Other trials in Argentina

About this study

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

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).

Being tested
Tislelizumab, Ociperlimab, Pembrolizumab, Placebo
Keywords
Locally Advanced, Unresectable, Metastatic, Tislelizumab, BGB-A317, Ociperlimab, BGB-A1217, Pembrolizumab, Anti-TIGIT
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317

    Tislelizumab is a monoclonal antibody formulated for intravenous injection.

  • OciperlimabDrug

    Also called BGB-A1217

    Ociperlimab is a monoclonal antibody formulated for intravenous injection.

  • PembrolizumabDrug

    Also called KEYTRUDA

    Pembrolizumab is a monoclonal antibody formulated for intravenous injection.

  • PlaceboDrug

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

Study groups in NCT04746924
Study groupRoleWhat they receive
Arm A: Ociperlimab plus TislelizumabExperimentalParticipants 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.
Receives: Drug: Tislelizumab; Drug: Ociperlimab
Arm B: Pembrolizumab plus PlaceboActive comparatorParticipants received pembrolizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
Receives: Drug: Pembrolizumab; Drug: Placebo
Arm C: Tislelizumab plus PlaceboPlacebo comparatorParticipants received tislelizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
Receives: Drug: Tislelizumab; Drug: Placebo
Safety Run-In SubstudyExperimentalJapanese 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.
Receives: Drug: Tislelizumab; Drug: Ociperlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization until the end of the study. Maximum time on study was 45.0 months

  2. 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.

    Measured: From first dose of study drug to 30 days after last dose. Maximum treatment duration was 12.45 months.

  3. Safety Run-In Substudy: Serum Concentration of Ociperlimab

    Measured: 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)

  1. 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.

    Measured: Up to 45.0 months

  2. 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.

    Measured: Up to 38.9 months

  3. 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.

    Measured: Response was assessed every 9 weeks from randomization for the first 52 weeks and then every 12 weeks thereafter, up to 45.0 months

  4. 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.

    Measured: Response was assessed every 9 weeks from randomization for the first 52 weeks and then every 12 weeks thereafter, up to 38.9 months

  5. 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.

    Measured: Up to 45.0 months

  6. 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.

    Measured: Up to 38.9 months

  7. 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.

    Measured: Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks

  8. 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.

    Measured: Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks

  9. 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.

    Measured: Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks

  10. 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.

    Measured: Up to 45.0 months

  11. 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.

    Measured: Up to 45.0 months

  12. 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.

    Measured: 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

  13. Safety Run-In Substudy: Participants With Anti-Drug Antibodies

    Measured: Up to 38.9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start24 May 2021
  3. Primary completion30 May 2025
  4. Study completion18 Mar 2026

Why it stopped: This decision was conducted by the sponsor based on lack of efficacy and not driven by safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
669 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04746924
Sponsor's protocol ID
AdvanTIG-302
Other IDs
BGB-A317-A1217-302, CTR20211476/CTR20211464, 2020-004985-21, 2023-507317-10-00, 2023
Status last verified
Apr 2026
First submitted
5 Feb 2021
Last updated
12 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Socinski MA, Reck M, Paz-Ares L, Nishio M, Spira AI, Yu X, Melkadze T, Zeng A, Martinez-Bueno A, Li X, Arulananda S, Zuo Y, Chica-Duque S, Dai W, Zhou J, Tan W, Lu S. AdvanTIG-302: Phase 3 Study of Ociperlimab (Anti-TIGIT) + Tislelizumab (Anti-PD-1) Versus Pembrolizumab in Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer With PD-L1 >/=50. J Thorac Oncol. 2026 Jul 14:104089. doi: 10.1016/j.jtho.2026.104089. Online ahead of print.

    PubMed 42448175

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Ociperlimab and Pembrolizumab in people with Non-small Cell Lung Cancer and NSCLC, run by BeiGene at 218 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 218 sites in China, Spain, Japan, France, Australia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in Arms A and B (time frame: From randomization until the end of the study. Maximum time on study was 45.0 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04746924, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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