NCT04746924

Brief Summary

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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Strong global presence with extensive site network
Enrollment
662

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jun 2021

Geographic Reach
19 countries

218 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

February 5, 2021

Last Update Submit

June 23, 2025

Conditions

Keywords

Locally AdvancedUnresectableMetastaticTislelizumabBGB-A317OciperlimabBGB-A1217PembrolizumabAnti-TIGIT

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    OS will be defined as the time from the date of randomization to the date of death due to any cause.

    Up to approximately 58 months

Secondary Outcomes (8)

  • Progression-free Survival (PFS) As Assessed By Investigators

    Up to approximately 58 months

  • Overall Response Rate (ORR) As Assessed By Investigators

    Up to approximately 58 months

  • Duration Of Response (DOR) As Assessed By Investigators

    Up to approximately 58 months

  • Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Within 7 days after permanent treatment discontinuation

  • HRQoL: EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) HRQoL will be assessed via PRO using the EORTC QLQ-LC13.

    Within 7 days after permanent treatment discontinuation

  • +3 more secondary outcomes

Study Arms (3)

Arm A: Tislelizumab plus Ociperlimab

EXPERIMENTAL

Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.

Drug: TislelizumabDrug: Ociperlimab

Arm B: Pembrolizumab plus Placebo

ACTIVE COMPARATOR

Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

Drug: PembrolizumabDrug: Placebo

Arm C: Tislelizumab plus Placebo

PLACEBO COMPARATOR

Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

Drug: TislelizumabDrug: Placebo

Interventions

Tislelizumab is a monoclonal antibody formulated for intravenous injection.

Also known as: BGB-A317
Arm A: Tislelizumab plus OciperlimabArm C: Tislelizumab plus Placebo

Ociperlimab is a monoclonal antibody formulated for intravenous injection.

Also known as: BGB-A1217
Arm A: Tislelizumab plus Ociperlimab

Pembrolizumab is a monoclonal antibody formulated for intravenous injection.

Also known as: KEYTRUDA
Arm B: Pembrolizumab plus Placebo

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

Arm B: Pembrolizumab plus PlaceboArm C: Tislelizumab plus Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (218)

Providence Medical Foundation St Jude Heritage Healthcare

Fullerton, California, 92835, United States

Location

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

Location

Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala

Ocala, Florida, 34474, United States

Location

Advent Health Cancer Institute

Orlando, Florida, 32804, United States

Location

Goshen Center For Cancer Care

Goshen, Indiana, 46526, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University Medical Center New Orleans West Jefferson Medical Center

New Orleans, Louisiana, 70112, United States

Location

Metro Minnesota Community Oncology Research Consortium (Mmcorc)

Saint Paul, Minnesota, 55101, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Centro Medical Austral

Buenos Aires, 1409, Argentina

Location

Centro Para La Atencion Del Paciente Oncologico (Caipo)

San Miguel de Tucumán, 4000, Argentina

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Northern Cancer Institute

St Leonards, New South Wales, 2065, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Mater Cancer Care Centre

South Brisbane, Queensland, 4101, Australia

Location

John Flynn Private Hospital

Tugun, Queensland, 4224, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

Ballarat Health Services

Ballarat, Victoria, 3350, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Western Health Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

St John of God, Murdoch

Murdoch, Western Australia, 6150, Australia

Location

Instituto Dor de Pesquisa E Ensino Distrito Federal

Brasília, 70390140, Brazil

Location

Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, 29308-020, Brazil

Location

Centro de Pesquisas Oncologicas Cepon

Florianópolis, 88034-000, Brazil

Location

Cancer Institute of Ceara

Fortaleza, 60430-235, Brazil

Location

Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia

Santo André, 09060-650, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, 15090-000, Brazil

Location

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

The First Affiliated Hospital of Army Military Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Chongqing University Three Gorges Central Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510030, China

Location

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515031, China

Location

Shenzhen Peoples Hospital

Shenzhen, Guangdong, 518020, China

Location

The Peoples Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

The Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

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

Wuhan, Hubei, 430022, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

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

Changzhou, Jiangsu, 213003, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210009, China

Location

Nanjing Chest Hospital

Nanjing, Jiangsu, 210029, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

The First Affiliated Hospital of Soochow University Branch Shizi

Suzhou, Jiangsu, 215006, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

The Affiliated Hospital of Qingdao University Branch Laoshan

Qingdao, Shandong, 266000, China

Location

Weifang Peoples Hospital

Weifang, Shandong, 261000, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

Location

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, 610041, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

Taizhou Hospital of Zhejiang

Taizhou, Zhejiang, 317000, China

Location

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location

Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie

Bayonne, 64100, France

Location

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, 33076, France

Location

Hopital de La Croix Rousse

Lyon, 69317, France

Location

Hopital Louis Pradel

Lyon, 69500, France

Location

Icm Val Daurelle Oncologie Medicale

Montpellier, 24298, France

Location

Polyclinique de Gentilly

Nancy, 54100, France

Location

Hopital Cochin

Paris, 75014, France

Location

Chu Hopital Lyon Sud

PierreBenite, 69495, France

Location

Hia Begin

Saint-Mandé, 94160, France

Location

Chu de La Reunion

Saint-Pierre, 97448, France

Location

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

SaintHerblain, 44805, France

Location

Chu Nantes Hopital Nord Laennec

SaintHerblain, 44805, France

Location

Chu Tours Hopital Bretonneau Service Pneumologie

Tours, 37000, France

Location

High Technology Hospital Medcenter Ltd

Batumi, 6000, Georgia

Location

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

Tbilisi, 0112, Georgia

Location

Israel Georgian Medical Research Clinic Helsicore Ltd

Tbilisi, 0112, Georgia

Location

Jsc German Hospital

Tbilisi, 0119, Georgia

Location

Institute of Clinical Oncology Ltd

Tbilisi, 0159, Georgia

Location

Jsc Evex Hospitals Tbilisi

Tbilisi, 0159, Georgia

Location

Tim Tbilisi Institute of Medicine Ltd

Tbilisi, 0160, Georgia

Location

Caucasus Medical Centre Ltd

Tbilisi, 0186, Georgia

Location

Multiprofile Clinic Consilium Medulla Ltd

Tbilisi, 0186, Georgia

Location

Oncology Research Center Ltd

Tbilisi, 0186, Georgia

Location

Universitaetsklinikum Aachen

Aachen, 52074, Germany

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Kliniken Der Stadt Koeln Ggmbh

Cologne, 51109, Germany

Location

Uniklinikum Giessen Marburg

Giessen, 35392, Germany

Location

Lungenclinic Grosshansdorf Gmbh

Grohansdorf, 22927, Germany

Location

Ambulantes Krebszentrum Hamburg

Hamburg, 20251, Germany

Location

Munchen Klinik Bogenhausen

Munich, 81925, Germany

Location

Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh

Rotenburg (Wümme), 27356, Germany

Location

Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera Papardo

Messina, 98158, Italy

Location

Aou San Luigi Gonzaga

Orbassano, 10043, Italy

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Hirosaki University Hospital

Hirosaki, Aomori, 036-8563, Japan

Location

Nho Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

National Hospital Organization Shibukawa Medical Center

Shibukawa, Gunma, 337-0280, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Hyogo Medical University Hospital

Nishinomiyashi, Hyōgo, 663-8501, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

Miyagi Cancer Center

Natorishi, Miyagi, 981-1293, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

Location

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191, Japan

Location

National Hospital Organization Kinki Chuo Chest Medical Center

Sakai, Osaka, 591-8555, Japan

Location

Kindai University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Osaka Toneyama Medical Center

Toyonaka, Osaka, 560-8552, Japan

Location

Jichi Medical University Hospital

Shimonotsuke, Tochigi, 329-0498, Japan

Location

Dokkyo Medical University Hospital

Shimotsugagun, Tochigi, 321-0293, Japan

Location

Tochigi Cancer Center

Utsunomiya, Tochigi, 320-0834, Japan

Location

Nippon Medical School Hospital

Bunkyoku, Tokyo, 113-8603, Japan

Location

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, 135-8550, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands

Location

Rijnstate

Arnhem, 6815 AD, Netherlands

Location

Ziekenhuis St Jansdal

Harderwijk, 3844 DG, Netherlands

Location

Stichting Zuyderland Medisch Centrum

Heerlen, 6419 PC, Netherlands

Location

Isala Klinieken Zwolle

Zwolle, 8025 AB, Netherlands

Location

Uniwersytecki Szpital Kliniczny W Bialymstoku

Bialystok, 15-276, Poland

Location

Centrum Terapii Wspoczesnej

Lodz, 90-338, Poland

Location

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, 93-510, Poland

Location

Wielkopolskie Centrum Pulmonologii I Torakochirurgii

Poznan, 60-569, Poland

Location

Przychodnia Med Polonia Sp Z Oo

Poznan, 60-693, Poland

Location

Etg Zamosc

Zamość, 22-400, Poland

Location

Arkhangelsk Regional Clinical Oncological Dispensary

Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

Location

State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic

Ufa, Bashkortostan Republic, 450054, Russia

Location

State Budgetary Healthcare Institution Regional Oncology Dispensary Number

Magnitogorsk, Chelyabinsk Oblast, 455001, Russia

Location

Vitamed Llc

Moscow, Moscow, 121309, Russia

Location

State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary

Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia

Location

Bih of Omsk Region Clinical Oncology Dispensary

Omsk, Omsk Oblast, 644013, Russia

Location

State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary

Samara, Samaraskaya Oblast', 443031, Russia

Location

Llc Av Medical Group

Saint Petersburg, Sankt-Peterburg, 197082, Russia

Location

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo, 28644, South Korea

Location

Keimyung University Dongsan Hospital

Dalseogu, Daegu Gwang'yeogsi, 42601, South Korea

Location

The Catholic University of Korea Bucheon St Marys Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

Cha Bundang Medical Center, Cha University

Gyeonggido, Gyeonggi-do, 13496, South Korea

Location

The Catholic University of Korea, St Vincents Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, Gyeongsangbukdo, 41404, South Korea

Location

The Catholic University of Korea, Eunpyeong St Marys Hospital

Eunpyeonggu, Seoul Teugbyeolsi, 03312, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, 28922, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Vall Dhebron

Barcelona, 08035, Spain

Location

Hospital Universitari Quiron Dexeus

Barcelona, 8028, Spain

Location

Hospital General Universitario de Elche

Elche, 3203, Spain

Location

Ico Girona

Girona, 17007, Spain

Location

Hospital Universitario de Jaen

Jaén, 23007, Spain

Location

Complejo Hospitalario Universitario Insular Gran Canaria

Las Palmas, 35016, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Start Madrid Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario Doce de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, 07120, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitario Nuestra Senora de Valme

Seville, 41014, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Hospital Universitari I Politecnic La Fe

Valencia, 46026, Spain

Location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Taipei Tzu Chi Hospital

Taipei, 231405, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

National Taiwan University Hospital Yunlin Branch

Yunlin, 640, Taiwan

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Songklanagarind Hospital (Prince of Songkhla University)

Hat Yai, 90110, Thailand

Location

Chulabhorn Research Institute

Lak Si, 10210, Thailand

Location

Srinagarind Hospital (Khon Kaen University)

Muang, 40002, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

Muang, 50200, Thailand

Location

Phramongkutklao Hospital

Ratchathewi, 10400, Thailand

Location

Rajavithi Hospital

Ratchathewi, 10400, Thailand

Location

Acibadem Adana Hospital

Adana, 01130, Turkey (Türkiye)

Location

Baskent University Practice and Research Hospital Adana Medical Oncology Department

Adana, 1240, Turkey (Türkiye)

Location

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Memorial Ankara Hospital

Ankara, 6520, Turkey (Türkiye)

Location

Inonu Universitesi Tip Fakultesi

Battalgazi, 44280, Turkey (Türkiye)

Location

Tr Trakya University Health Research and Application Center (Hospital)

Edirne, 22030, Turkey (Türkiye)

Location

Iu C, Clinical Research Excellence Application and Research Center

Istanbul, 34098, Turkey (Türkiye)

Location

Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, 34722, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Kocaeli Universitesi Tip Fakultesi

Kocaeli, 41380, Turkey (Türkiye)

Location

Necmettin Erbakan University Selcuklu Faculty of Medicine

Meram, 42090, Turkey (Türkiye)

Location

Mersin City Hospital

Mersin City Hospital, 33240, Turkey (Türkiye)

Location

Medical Center of Limited Liability Company Mriya Med Service

Kryvyi Rih, 50000, Ukraine

Location

Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council

Uzhhorod, 88000, Ukraine

Location

Zakarpatska Regional Clinical Oncological Center

Uzhhorod, 88011, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis

Interventions

tislelizumabpembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 10, 2021

Study Start

June 8, 2021

Primary Completion

May 30, 2025

Study Completion

March 31, 2026

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Locations