Lung Cancer Clinical Trial

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

Summary

The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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 RECIST v1.1.
ECOG Performance Status ≤ 1.

Key Exclusion Criteria:

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

660

Study ID:

NCT04746924

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 211 Locations for this study

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UAB O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Alaska Oncology and Hematology, LLC
Anchorage Alaska, 99508, United States
Providence Medical Foundation
Fullerton California, 92835, United States
Valkyrie Clinical Trials
Los Angeles California, 90067, United States
Providence Medical Foundation Santa Rosa
Santa Rosa California, 95405, United States
Ocala Oncology, Florida Cancer Affiliates
Ocala Florida, 34474, United States
Advent Health Oncology and Hematology
Orlando Florida, 32804, United States
Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
West Jefferson Medical Center Cancer Center (University Medical Center New Orleans)
Marrero Louisiana, 70072, United States
HealthPartners Institute - MMCORC (Metro Minnesota Community Oncology Research Consortium)
Saint Paul Minnesota, 55426, United States
XCancer / Central Care Cancer Center
Bolivar Missouri, 65613, United States
Jefferson City Medical Group
Jefferson City Missouri, 65109, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87106, United States
Memorial Medical Center
Las Cruces New Mexico, 88011, United States
Penn State Health Cancer Institute
Hershey Pennsylvania, 17033, United States
West Penn Hospital (Allegheny Health Network)
Pittsburgh Pennsylvania, 15224, United States
Virginia Cancer Specialist, PC
Fairfax Virginia, 22031, United States
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia
Northern Cancer Institute, Genesis Care
Saint Leonards New South Wales, 2065, Australia
Calvary Mater Newcastle, Medical Oncology Trial Unit, Edith Street
Waratah New South Wales, 2298, Australia
Pindara Private Hospital
Benowa Queensland, 4217, Australia
The Prince Charles Hospital
Chermside Queensland, 4032, Australia
Mater Cancer Care Centre
South Brisbane Queensland, 4101, Australia
John Flynn Private Hospital
Tugun Queensland, 4224, Australia
Lyell McEwin Hospital
Elizabeth Vale South Australia, 5112, Australia
Ballarat Health Services
Ballarat Victoria, 3350, Australia
Monash Health
Clayton Victoria, 3168, Australia
Western Health - Sunshine Hospital
St Albans Victoria, 3021, Australia
St John of God, Murdoch Hospital
Murdoch Western Australia, 6150, Australia
Anhui Provincial Hospital
Hefei Anhui, 23000, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
Beijing Chest Hospital, Capital Medical University
Beijing Beijing, 10149, China
Southwest Hospital
Chongqing Chongqing, 40003, China
Chongqing Three Gorges Central Hospital
Chongqing Chongqing, 40400, China
Fujian Medical University Union Hospital
Fuzhou Fujian, 35000, China
Fujian Cancer Hospital
Fuzhou Fujian, 35001, China
The First Affiliated Hospital of Xiamen University
Xiamen Fujian, 36100, China
Cancer Center of Guangzhou Medical University
Guangzhou Guangdong, 51003, China
Cancer Hospital of Shantou University Medical College
Shantou Guangdong, 51503, China
Shenzhen People's Hospital
Shenzhen Guangdong, 51802, China
Cancer Hospital of Guangxi Zhuang Autonomous Region
Nanning Guangxi, 53002, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning Guangxi, 53002, China
Affiliated Tumor Hospital of Harbin Medical University
Harbin Heilongjiang, 15000, China
The First Affiliated Hospital of Zhengfzhou University
Zhengzhou Henan, 40005, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Henan Provincial People's Hospital
Zhengzhou Henan, 45000, China
Hubei Cancer Hospital
Wuhan Hubei, 40003, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
Renmin Hospital of Wuhan University
Wuhan Hubei, 43006, China
The Second Xiangya Hospital of Central South University
Changsha Hunan, 41001, China
Nanjing First Hospital
Nanjing Jiangsu, 21000, China
Nanjing Chest Hospital
Nanjing Jiangsu, 21002, China
The First Affiliated Hospital of Soochow University
Suzhou Jiangsu, 21500, China
Liaoning Cancer Hospital & Institute
Shenyang Liaoning, 11004, China
The Affiliated Hospital of Qingdao University
Qingdao Shandong, 26600, China
Weifang People's Hospital
Weifang Shandong, 26100, China
Shanghai Chest Hospital
Shanghai Shanghai, 20003, China
Shanxi Bethune Hospital
Taiyuan Shanxi, 03003, China
Sichuan Cancer Hospital & Institute
Chengdu Sichuan, 61004, China
Tianjin Medical University General Hospital
Tianjin Tianjin, 30005, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin Tianjin, 30006, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi Xinjiang, 83000, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou Zhejiang, 31001, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Ningbo First Hospital
Ningbo Zhejiang, 31501, China
Beijing Chao-Yang Hospital
Beijing , 10002, China
Peking Union Medical College Hospital
Beijing , 10073, China
Hunan Cancer Hospital
Changsha , 41001, China
Changzhou No.2 People's Hospital
Changzhou , 21300, China
West China Hospital, Sichuan University
Chengdu , 61004, China
Chongqing Cancer Hospital
Chongqing , 40003, China
Daping Hospital, Third Military Medical University
Chongqing , 40004, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou , 51012, China
The Second Hospital of Anhui Medical University
Hefei , 23060, China
The First Affiliated Hospital of Nanchang University
Nanchang , 33000, China
Affiliated Hospital of North Sichuan Medical College
Nanchong , 63700, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai , 20003, China
Shanghai Pulmonary Hospital
Shanghai , 20043, China
The Second Affiliated Hospital of Soochow University
Suzhou , 21500, China
Taizhou Hospital of Zhejiang Province
Taizhou , 31700, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , 71006, China
Xuzhou Central Hospital
Xuzhou , 22100, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
The Fourth Affiliated Hospital Zhejinaang University School of Medicine
Yiwu , 32200, China
Institut de Cancérologie de L'Ouest
Angers , 49055, France
Centre Hospitalier de la Cote Basque - Saint Léon - Service de Pneumologie
Bayonne , 64109, France
Hospices Civils de Lyon- Hopital Louis Pradel
Bron , 69500, France
CHI de Creteuil
Créteil , 94000, France
Hospices Civils de Lyon-Hôpital de la Croix Rousse
Lyon , 69004, France
Centre Leon Berard
Lyon , 69373, France
ICM Val Daurelle - Oncologie Médicale
Montpellier , 34298, France
Centre Hospitalier Emile Muller Ghrmsa
Mulhouse , 68100, France
Clinique Gentilly
Nancy , 54100, France
Hopital Cochin
Paris , 75014, France
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre-Bénite , 69310, France
HIA Begin
Saint-Mandé , 94160, France
Chu Tours - Hopital Bretonneau - Service Pneumologie 2
Tours , 37000, France
High Technology Hospital Medcenter LTD
Batumi , 6000, Georgia
Acad. Fridon Todua medical Center LTD - Research Institute of Clinical Medicine LTD
Tbilisi , 0112, Georgia
Israel-Georgian Medical Research Clinic Helsicore LTD
Tbilisi , 0112, Georgia
Multiprofile Clinic Consilium Medula LTD
Tbilisi , 0186, Georgia
Oncology Research Center LTD
Tbilisi , 0186, Georgia
Timi - Tbilisi Institute of Medicine LTD
Tbilisi , 0186, Georgia
Universitaetsklinikum Aachen
Aachen , 52074, Germany
Helios Klinikum Bad Saarow
Bad Saarow , 15526, Germany
Charite Universitatsmedizin Berlin
Berlin , 13353, Germany
Asklepios Fachklinik Munchen-Gauting
Gauting , 82131, Germany
Lungenclinic Grosshansdorf GMBH
Großhansdorf , 22927, Germany
Ambulantes Krebszentrum Hamburg
Hamburg , 20251, Germany
Uniklinikum Giessen Marburg
Heidelberg , 35392, Germany
Universitatsklinikum Bonn
Kiel , 53127, Germany
Kliniken Der Stadt Koeln GGMBH
Köln , 51109, Germany
Onkologische Scwerpunktpraxis Leer - Emden
Leer , 26789, Germany
Klinikum Ludwigshafen, Medizinische Klinik A
Ludwigshafen , 67063, Germany
Klinikum Johannes-Gutenberg-Universitaet Mainz
Mainz , 55131, Germany
Klinikum Der Universitat muenchen - Campus Innenstadt
Muenchen , 80336, Germany
Muenchen Klinik Bogenhausen
Muenchen , 80336, Germany
Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige GMBH
Rotenburg , 27356, Germany
Universitaetsklinikum Ulm, Innere Medizin III
Ulm , 89081, Germany
Onkologische Schwerpunkt-Praxis-Worms
Worms , 57547, Germany
Cro Irccs Aviano
Via Franco Gallini Aviano, 33081, Italy
Istituto Romagnolo per Studio, dei Tumori "Dino Amadori"
Meldola , 47017, Italy
Azienda Ospedaliera Papardo
Messina , 98158, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Aou San Luigi Gonzaga
Orbassano , 10043, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona , 37126, Italy
Nagoya University Hospital
Nagoya Aichi, 003-0, Japan
Kobe City Medical Center General Hospital
Kobe Hyogo, 650-0, Japan
Okayama University Hospital
Okayama-shi Okayama-ken, 700-8, Japan
Cancer Institute Hospital of JFCR
Koto-ku Tokyo-To, 135-8, Japan
Kanagawa Cancer Center
Kanagawa , 241-8, Japan
Nagaoka Red Cross Hospital
Niigata , 940-2, Japan
The Catholic University of Korea, Bucheon St. Mary's Hospital
Gyeonggi-do Bucheon-si, 14647, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu Buk-gu, 41404, Korea, Republic of
Chungbuk National University Hospital
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu Dalseo-gu, 42601, Korea, Republic of
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul Eunpyeong-gu, 03312, Korea, Republic of
Inje University Haeundae Paik Hospital
Busan Haeundae-gu, 48108, Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam-si , 13496, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
Suwon-Si , 16247, Korea, Republic of
Meander Medisch Centrum
Amersfoort , 3813, Netherlands
Stichting Het Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066, Netherlands
Rijnstate
Arnhem , 6815, Netherlands
Ziekenhuis St Jansdal
Harderwijk , 3844, Netherlands
Stichting Zuyderland Medisch Centrum
Heerlen , 6419, Netherlands
Isala Klinieken Zwolle
Zwolle , 8025, Netherlands
Uniwersytecki Szpital Kliniczny w Białymstoku
Białystok , 15-27, Poland
Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością
Gdynia , , Poland
Przychodnia Med-Polonia Sp. z o.o.
Poznan , 60-69, Poland
Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Łódź , , Poland
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangel'sk , 16304, Russian Federation
State Budgetary Healthcare Institution-Chelyabinsk Regional Clinical Center of Oncology and Nuclear
Chelyabinsk , 45408, Russian Federation
Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical"
Kursk , 30503, Russian Federation
State Budgetary Healthcare Institution-Regional Oncology Dispensary Number 2
Magnitogorsk , 45500, Russian Federation
"Vitamed" LLC
Moscow , 12130, Russian Federation
State Budgetary Healthcare Institution "City Clinical Hospital #1"
Nalchik , 36000, Russian Federation
State Budgetary Healthcare Institution - Nizhny Novgorod Regional Clinical Oncology Dispensary
Nizhny Novgorod , 60308, Russian Federation
BIH of OMSK Region "Clinical Oncology Dispensary"
Omsk , 64401, Russian Federation
Private Healthcare Institution - Clinical Hospital Russian Railways - Medicine of the City of St. Petersburg
Saint Petersburg , 19527, Russian Federation
Private Medical Institution "Evromedservis"
Saint Petersburg , 19660, Russian Federation
LLC AV-Medical Group
Saint Petersburg , 19708, Russian Federation
The Smorodintsev Research Institute of Influenze
Saint Petersburg , 19737, Russian Federation
FSBI "Clinical Research and Practical Center for Specialized Medical Care (Oncology)"
Saint Petersburg , 19775, Russian Federation
FSBI "National Medical Research Center for Oncology N.A.N.N. Petrov" of the MOH of the RF
Saint Petersburg , 19775, Russian Federation
State Budgetary Healthcare Institution - Samara Regional Clinical Oncology Dispensary
Samara , 44303, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Morodov"
Saransk , 43003, Russian Federation
State Autonomous Healthcare Institution - Republican Clinical Oncological Dispensary of the Republic
Ufa , 45005, Russian Federation
ICO-H.U.G. Trias I Pujol
Badalona , 08916, Spain
Hospital Del Mar
Barcelona , 08003, Spain
Hospital Universitari Quiron Dexeus
Barcelona , 08028, Spain
Hospital Universitario Vall D'Hebron
Barcelona , 8035, Spain
Hospital Universitario Donostia
Donostia , 20014, Spain
Hospital General Universitario de Elche
Elche , 03203, Spain
ICO Girona
Girona , 17007, Spain
Hospital Universitario Insularde Gran Canaria
Las Palmas , 35016, Spain
Hospital Universitario Lucus Augusti
Lugo , 27003, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Start Madrid-Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario Doce de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , 28220, Spain
Hospital General Universitario Morales Meseguer
Murcia , 30008, Spain
Hospital Universitario Virgen de la Victoria
Málaga , 29010, Spain
Hospital Regional Universitario de Malaga
Málaga , 29011, Spain
Complexo Hospitalario Universitario de Ourense
Orense , 32005, Spain
Hospital Universitari son Espases
Palma De Mallorca , 07120, Spain
Hospital Universitario Nuestra Señora de Valme
Sevilla , 41014, Spain
Consorcio Hospital General Universitario de Valencia
Valencia , 46014, Spain
Hospital Arnau de Vilanova
Valencia , 46015, Spain
Hospital Universitari I Politecnic La Fe
Valencia , 46026, Spain
Changhua Christian Hospital
Changhua , 50006, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 83301, Taiwan
Chung Shan Medical University Hospital
Taichung , 40201, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Taipei Tzu Chi Hospital
Taipei , 23140, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan , 33305, Taiwan
National Taiwan University Hospital Yunlin Branch
Yuanlin , 00640, Taiwan
Chulabhorn Research Institute
Bangkok , 10210, Thailand
Siriraj Hospital
Bangkok , 10700, Thailand
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai , 90110, Thailand
Srinagarind Hospital (Khon Kaen University)
Mueang Nonthaburi , 40002, Thailand
Bangkok Hospital Chiang Mai
Mueang Nonthaburi , 50000, Thailand
Phramongkutklao Hospital
Ratchathewi , 10400, Thailand
Rajavithi Hospital
Ratchathewi , 10400, Thailand
Acibadem Adana Hospital
Adana , 01130, Turkey
Baskent University Practice and Research Hospital Adana - Medical Oncology Department
Adana , 01240, Turkey
İInönü Üniversitesi Tip Fakültesi
Battalgazi , 44280, Turkey
Trakya University Medical Faculty
Edirne , 22030, Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul , 34096, Turkey
Istanbul Medeniyet Uni Goztepe Training & Res Hosp
Istanbul , 34854, Turkey
Ege University Medical Faculty
İzmir , 35100, Turkey
Necmettin Erbakan University Selcuklu Faculty of Medicine
Meram , 42090, Turkey
Bukovynian Clinical Oncology Center
Chernivtsi , 58013, Ukraine
Komunalne Nekomertsiine Pidryiemstvo - Miska Klinichna Likarnia #4
Dnepropetrovsk , 49102, Ukraine
Komunalne Nekomertsiine Pidryiemstvo Oblasnyi Tsentr Onkolohii
Kharkiv , 61070, Ukraine
Kryvyi RIH Oncological Dispensary
Kryvyi Rih , 50048, Ukraine
Medical Center "Verum" Limited Liability Company
Kyiv , 03039, Ukraine
Public Non-profit Institution "Kyiv City Clinical Oncology Center"
Kyiv , 03115, Ukraine
Volyn Regional Medical Center of Oncology
Luts'k , 43018, Ukraine
Lviv State Regional Oncology Treatment and Diagnostic Center
Lviv , 79031, Ukraine
Odessa Regional Oncological Dispensary
Odesa , 65010, Ukraine
Communal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar
Sumy , 40003, Ukraine
Zakarpatska Regional Clinical Oncological Center
Uzhgorod , 88011, Ukraine
Podolsk Regional Oncology Center
Vinnytsia , 21029, Ukraine
Zaporozhye Regional Antitumor Center
Zaporizhia , 69061, Ukraine
Medical Center of Llc Oncolife
Zaporizhzhya , 69059, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

660

Study ID:

NCT04746924

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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