Non-small Cell Lung CancerPhase 3RELATIVITY1093NCT06561386
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
A Phase 3 study testing Nivolumab, Relatlimab and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 329 sites in 31 countries.
Trial summary
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1% Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Nivolumab, Relatlimab and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 329 sitesin 31 countries
- Study dates
- 7 Oct 2024to 4 Aug 2032
- Phase
- Phase 3
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
- Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
- Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
- Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
- Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
- Participants must have a life expectancy of at least 3 months at the time of randomization.
Who cannot join
- Participants must not be pregnant and/or breastfeeding.
- Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
- Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
- Participants must not have untreated central nervous system (CNS) metastases.
- Participants must not have leptomeningeal metastases (carcinomatous meningitis).
- Participants must not have concurrent malignancy requiring treatment.
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- Participants must not have an active autoimmune disease.
- Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.
- Participants must not have a history of myocarditis.
- Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
329 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
329 sites in 31 countries
United States58 sites, 39 recruiting
- Recruiting
Texas Oncology - West Texas
Abilene, Texas, 79606
Pankaj Khandelwal, Site 0359, 000-000-0000
- Completed
Local Institution - 0381
Albuquerque, New Mexico, 87108
- Not yet recruiting
Local Institution - 0505
Annapolis, Maryland, 21401
Site 0505
- Completed
Local Institution - 0352
Asheville, North Carolina, 28806
- Completed
Local Institution - 0308
Bozeman, Montana, 59715
- Withdrawn
Local Institution - 0369
Canton, Ohio, 44708
- Not yet recruiting
Local Institution - 0486
Centerville, Ohio, 45459
Site 0486
- Completed
Local Institution - 0376
Chicago Ridge, Illinois, 60415
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Jennifer Leddon, Site 0141
- Completed
Local Institution - 0199
Cleveland, Ohio, 44106
- Not yet recruiting
Local Institution - 0509
Coeur d'Alene, Idaho, 83815
Site 0509
- Recruiting
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, 41017
Colleen Darnell, Site 0128, 859-301-4000
- Not yet recruiting
Local Institution - 0515
Edmonds, Washington, 98026
Site 0515
- Not yet recruiting
Local Institution - 0519
Elyria, Ohio, 44035
Site 0519
- Not yet recruiting
Local Institution - 0500
Grand Junction, Colorado, 81501
Site 0500
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Sameer Batoo, Site 0351, 252-744-4929
- Withdrawn
Local Institution - 0305
Harlingen, Texas, 78550
- Completed
Local Institution - 0226
Hattiesburg, Mississippi, 39401-7233
- Completed
Local Institution - 0356
Hawthorne, New York, 10532
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mehmet Altan, Site 0378, 203-809-3721
- Not yet recruiting
Local Institution - 0517
Houston, Texas, 77090
Site 0517
- Withdrawn
Local Institution - 0516
Issaquah, Washington, 98029
- Not yet recruiting
Local Institution - 0498
Kansas City, Missouri, 64132
Site 0498
- Not yet recruiting
Local Institution - 0499
Lacey, Washington, 98503
Site 0499
- Recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601
Samuel Kerr, Site 0272, 717-215-9561
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
Firas Badin, Site 0130, 859-260-6100
- Withdrawn
Local Institution - 0112
Los Angeles, California, 90404
- Withdrawn
Local Institution - 0366
Massillon, Ohio, 44646
- Completed
Local Institution - 0206
Miami, Florida, 33136
- Not yet recruiting
Local Institution - 0487
Mobile, Alabama, 36604
Site 0487
- Not yet recruiting
Local Institution - 0507
Morristown, New Jersey, 07960
Site 0507
- Completed
Local Institution - 0392
New York, New York, 10016
- Withdrawn
Local Institution - 0380
Northport, New York, 11768
- Not yet recruiting
Local Institution - 0502
Paducah, Kentucky, 42003
Site 0502
- Completed
Local Institution - 0346
Paterson, New Jersey, 07503
- Completed
Local Institution - 0162
Pembroke Pines, Florida, 33028
- Not yet recruiting
Local Institution - 0504
Philadelphia, Pennsylvania, 19107
Site 0504
- Not yet recruiting
Local Institution - 0520
Philadelphia, Pennsylvania, 19114
Site 0520
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Katharine Thomas, Site 0207, 775-985-4000
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Arpan Patel, Site 0325, 315-525-2102
- Recruiting
Profound Research LLC - MHP MedOnc Royal Oak - Oakland Medical Group Location
Royal Oak, Michigan, 48073
Jeffrey Margolis, Site 0473, 000-000-0000
- Recruiting
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
Tianhong Li, Site 0304, 718-555-1212
- Not yet recruiting
Local Institution - 0302
Salt Lake City, Utah, 84112
Site 0302
- Completed
Local Institution - 0159
San Francisco, California, 94115
- Recruiting
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
Edward Garon, Site 0111, 310-926-5333
- Not yet recruiting
Local Institution - 0511
Schenectady, New York, 12308
Site 0511
- Not yet recruiting
Local Institution - 0508
Seattle, Washington, 98122
Site 0508
- Recruiting
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705
Mamta Choksi, Site 0358, 727-842-8411
- Not yet recruiting
Local Institution - 0523
Summit, New Jersey, 07960
Site 0523
- Recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
Bhaskara Reddy Madhira, Site 0324, 314-691-8862
- Recruiting
Florida Clinical Trials Group.
Tamarac, Florida, 33321
Chintan Gandhi, Site 0477, 561-447-0614
- Withdrawn
Local Institution - 0357
The Bronx, New York, 10468
- Recruiting
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Thomas Hanzlik, Site 0368, 580-792-1450
- Recruiting
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
Tyler, Texas, 75701
Robert Droder, Site 0303, 903-595-7093
- Recruiting
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401
Todd Gersten, Site 0360, 561-366-4100
- Not yet recruiting
Local Institution - 0472
Westminster, Colorado, 80023
Site 0472
- Recruiting
Cancer Center of Kansas
Wichita, Kansas, 67214
Shaker Dakhil, Site 0251, 316-262-4467
- Not yet recruiting
Local Institution - 0512
Zanesville, Ohio, 43701
Site 0512
China32 sites, 30 recruiting
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
Jian Fang, Site 0070, 861088196479
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Lin Wu, Site 0072, 8613170419973
- Recruiting
Sichuan Cancer hospital
Chengdu, Sichuan, 610041
Juan Li, Site 0121, +8613880276636
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Chunmei Wang, Site 0238, 8615111954802
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Haipeng Xu, Site 0075, 8613675007687
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Kejing Tang, Site 0098, 8613802946566
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510140
Haihong Yang, Site 0067, 13711244230
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510120
Chongrui Xu, Site 0307, 86208382781250815
- Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jianya Zhou, Site 0071, 8613858123060
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Enguo Chen, Site 0099, 13588706779
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xinmin Yu, Site 0338, 8613705718617
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yan Yu, Site 0102, 13904505825
- Not yet recruiting
Local Institution - 0182
Hefei, Anhui, 230031
Site 0182
- Recruiting
First Huai'an Hospital Affiliated to Nanjing Medical University
Huai'an, Jiangsu, 223300
Zili Meng, Site 0354, 13952399232
- Recruiting
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001
Ying He, Site 0326, 13928311788
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Ligang Xing, Site 0074, 86-15553181309
- Recruiting
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000
Dongqing LV, Site 0101, 13867622009
- Recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Jingzhang Li, Site 0353, 18078259868
- Recruiting
The First affiliated hospital of Nanchang University (Xianghu campus)
Nanchang, Jiangxi, 330209
Longhua Sun, Site 0451, 8613698091288
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530201
Qitao Yu, Site 0134, 13878106696
- Recruiting
The Second People's Hospital of Neijiang
Neijiang, Sichuan, 641000
Yu Liu, Site 0424, +8613698308655
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Zhen Zhou, Site 0064, 8618017321556
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong, Site 0280, 13818200560
- Recruiting
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200032
Yong Zhang, Site 0318, 15000229853
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Yuan Liang, Site 0181, +8615242080287
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
wei guo, Site 0435, 13834563396
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Peng Chen, Site 0177, 022-23340123
- Recruiting
Chongqing Three Gorges Central Hospital
Wanzhou, Chongqing Municipality, 404000
Wei Wang, Site 0244, 8613635324483
- Withdrawn
Local Institution - 0235
Wuhan, Hubei, 430079
- Recruiting
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710126
Kejun Nan, Site 0423, 8613319286228
- Recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453100
Yinghua Ji, Site 0420, 13663030446
- Completed
Local Institution - 0237
Zhengzhou, Henan, 450000
Japan25 sites, 23 recruiting
- Recruiting
Hyogo Cancer Center
Akashi, 6738558
Yoshihiro Hattori, Site 0327, 81789291151
- Recruiting
Fukushima Medical University
Fukushima, 960-1295
Naoyuki Okabe, Site 0319, 81245471111
- Recruiting
Chugoku Central Hospital
Fukuyama-shi, Hiroshima, 720-0001
Kenichi Gemba, Site 0276, +81849849702121
- Not yet recruiting
Local Institution - 0513
Gifu, 501-1194
Site 0513
- Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Naoki Inui, Site 0278, 81534352356
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Hiroshi Kagamu, Site 0274, +81-42-984-4111
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
Takayasu Kurata, Site 0275, 81728042503
- Recruiting
Nara Medical University Hospital
Kashihara, Nara, 634-0813
Masayuki Takeda, Site 0322, 81744223051
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Yu Tanaka, Site 0312, 81471331111
- Recruiting
University Of Occupational And Environmental Health Hospital
Kitakyushu, Fukuoka, 807-8556
Masaru Takenaka, Site 0320, 0936031611
- Recruiting
The Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550
Ken Uchibori, Site 0323, 81335200111
- Recruiting
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602
Toshihide Yokoyama, Site 0306, 81864220210
- Recruiting
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Koichi Azuma, Site 0273, 81942317629
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777
Hirotsugu Kenmotsu, Site 0310, 81559895222
- Not yet recruiting
Local Institution - 0514
Nakamura-ku,Nagoya, Aichi-ken, 453-8511
Site 0514
- Recruiting
Kochi Medical School Hospital
Nankoku, Kochi, 783-8505
TOSHIYUKI KOZUKI, Site 0444, +81888665811
- Recruiting
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293
Tatsuro Fukuhara, Site 0510, 81223843151
- Completed
Local Institution - 0279
Niigata, Niigata, 951-8566
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
Kazumi Nishino, Site 0340, 81669721181
- Recruiting
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
Katsuhiko Naoki, Site 0506, +81-42-778-8111
- Recruiting
Kindai University Hospital
Sakai, Osaka, 590-0197
Hidetoshi Hayashi, Site 0277, 81723681184
- Recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Satoshi Oizumi, Site 0311, +81118119111
- Recruiting
Sendai Kousei Hospital
Sendai, Miyagi, 9810914
Shunichi Sugawara, Site 0339, 81227288000
- Completed
Local Institution - 0449
Yokohama, Kanagawa, 236-0051
- Recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Seigo Katakura, Site 0321, 0455202222
France16 sites, 14 recruiting
- Recruiting
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, Vaucluse, 84918
Naila BACHA DUFOUR, Site 0471, 33490276090
- Recruiting
Centre Hospitalier de la Côte Basque
Bayonne, 64109
Sophie Schneider, Site 0421, 0559443885
- Recruiting
CHU de Bordeaux Hopital Saint Andre
Bordeaux, 33000
Charlotte Domblides, Site 0470, 33556795808
- Recruiting
CHRU de Brest
Brest, Finistère, 29200
Gilles Quere, Site 0462, 33298223578
- Recruiting
Centre Hospitalier Universitaire (CHU) Dijon Bourgogne - Hôpital François Miterrand
Dijon, Bourgogne-Franche-Comté, 21000
Ayoube Zouak, Site 0475
- Not yet recruiting
Local Institution - 0503
Le Mans, Pays de la Loire Region, 72037
Site 0503
- Recruiting
CHU Lille - Institut Coeur Poumon
Lille, Nord, 59037
Arnaud Scherpereel, Site 0096, 33320444998
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915
Laurent Greillier, Site 0158, 33491324400
- Withdrawn
Local Institution - 0092
Montpellier, Hérault, 34298
- Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014
Marie Wislez, Site 0089, 33158413091
- Recruiting
Institut Curie
Paris, 75248
nicolas girard, Site 0095, +33624456290
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, 69310
Sebastien Couraud, Site 0157, 33478865924
- Withdrawn
Local Institution - 0093
Rennes, Ille-et-Vilaine, 35033
- Recruiting
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, Provence-Alpes-Côte d'Azur Region, 83100
Clotilde Fournier, Site 0091, 33491965903
- Recruiting
CHU de Toulouse - Hopital Larrey
Toulouse, Haute-Garonne, 31059
Julien Mazieres, Site 0090, 33567771837
- Recruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
Bertrand Mennecier, Site 0395, 33383154653
Germany16 sites, 16 recruiting
- Recruiting
Charité Campus Virchow-Klinikum
Berlin, 13353
Nikolaj Frost, Site 0285, 004930450553044
- Recruiting
Universitätsklinikum Bonn
Bonn, 53127
Peter Brossart, Site 0282, 4922828722234
- Recruiting
Klinikum Chemnitz
Chemnitz, Saxony, 09116
Stefan Hammerschmidt, Site 0437, 4937133343550
- Recruiting
Gemeinschaftspraxis fuer Haematologie & Onkologie - Dortmund
Dortmund, North Rhine-Westphalia, 44263
Clemens Schulte, Site 0469
- Recruiting
Universitaetsklinikum Essen
Essen, 45122
Marcel Wiesweg, Site 0288, 020172385032
- Recruiting
Klinikum Esslingen
Esslingen am Neckar, Baden-Wurttemberg, 73730
Martin Faehling, Site 0284, +4971131032402
- Recruiting
Asklepios Klinik Gauting GmbH
Gauting, 82131
Niels Reinmuth, Site 0286, 004989857914001
- Recruiting
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, 22927
Martin Reck, Site 0316, 041026012101
- Recruiting
Praxis Onkologie am Raschplatz
Hanover, Lower Saxony, 30161
Eyck von der Heyde, Site 0436, 0177-6506614
- Recruiting
Evangelisches Krankenhaus Herne - Eickel
Herne, North Rhine-Westphalia, 44651
Daniel Christoph, Site 0397, +49232349892793
- Recruiting
Klinikverbund Allgaeu
Kempten (Allgäu), Bavaria, 87439
Christian Schumann, Site 0287, +4983239108171
- Recruiting
Universitatsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Sabine Bohnet, Site 0466, 4945150045002
- Recruiting
Universitätsklinikum Marburg
Marburg, Hesse, 35033
Charis Faoro, Site 0313, 4964215862784
- Recruiting
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Bavaria, 81377
Diego Kauffmann-Guerrero, Site 0347, 4989440052590
- Recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, 48149
Annalen Bleckmann, Site 0438, 492518352712
- Recruiting
Bundeswehrkrankenhaus Ulm
Ulm, Baden-Wurttemberg, 89081
Matthias Mueller, Site 0439, +490731171031253
Brazil15 sites, 15 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
Josiane Dias, Site 0152, 17996782301
- Recruiting
NAIC - Instituto do Câncer
Bauru, São Paulo, 17033-490
Marcelo Antunes, Site 0149, +5514997923873
- Recruiting
CTO - Centro de Tratamento Oncológico
Belém, Pará, 66063-495
Bruno Fernandes, Site 0375, 91999809897
- Recruiting
Cetus Oncologia - Unidade Belo Horizonte
Belo Horizonte, Minas Gerais, 30110-022
Elisa Ramos, Site 0078, 5531998619660
- Recruiting
Pronutrir
Fortaleza, Ceará, 60810180
Herbert Tavares Palmeira, Site 0382, 558532865934
- Recruiting
Clínica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220
Giuliano Borges, Site 0084, 5547984046243
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59075-740
Joilda Rego, Site 0151, 558440095595
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Rodrigo Pereira, Site 0083, 5551999734670
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Ana Caroline Gelatti, Site 0076, (51)3320-3039
- Recruiting
Instituto Nacional de Câncer - INCA
Rio de Janeiro, 20231-050
Luiz Henrique Araujo, Site 0232, 552132076585
- Recruiting
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, São Paulo, 09541-270
Daniel Cubero, Site 0373, 551199964-2770
- Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
Milena Perez Mak, Site 0147, 551138932632
- Not yet recruiting
Local Institution - 0496
São Paulo, 01323001
Site 0496
- Recruiting
Instituto do Câncer Brasil-unidade Taubaté
Taubaté, São Paulo, 12030-200
José Márcio Barros de Figueiredo, Site 0497
- Not yet recruiting
Local Institution - 0501
Timbó, Santa Catarina, 89120000
Site 0501
Italy14 sites, 13 recruiting
- Recruiting
Instituto Tumori Giovanni Paolo II
Bari, Apulia, 70124
Domenico Galetta, Site 0043, 390805555442
- Recruiting
Humanitas Gavazzeni
Bergamo, 24125
Chiara Catania, Site 0482, 3288372166
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
Lorenzo Antonuzzo, Site 0478, 00390557947298
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, 20162
Elio Pizzutilo, Site 0465
- Not yet recruiting
Local Institution - 0045
Monza, Lombardy, 20900
Site 0045
- Recruiting
A.O.R.N. Ospedale dei Colli - Monaldi V.
Naples, Napoli, 80131
Danilo Rocco, Site 0046, 390817064300
- Recruiting
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Naples, Napoli, 80131
Ferdinando Riccardi, Site 0049, +39817472223
- Recruiting
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, 90127
Valerio Gristina, Site 0479, +0916552507
- Recruiting
Casa di Cura Dott. Pederzoli
Peschiera del Garda, Verona, 37019
ANTONIO SANTO, Site 0221, 0456444843
- Recruiting
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48121
Manolo D Arcangelo, Site 0400, 390544285330
- Withdrawn
Local Institution - 0222
Ravenna, 48121
- Recruiting
Istituto Nazionale Tumori Regina Elena
Rome, Roma, 00144
Gabriele Minuti, Site 0250, 3485821765
- Recruiting
Azienda Ospedaliera San Camillo-Forlanini
Rome, 152
Giuditta di Isernia, Site 0481, +39066837249
- Not yet recruiting
Local Institution - 0480
Siena, 53100
Site 0480
South Korea13 sites, 13 recruiting
- Recruiting
Pusan National University Hospital
Busan, Pusan-Kwangyǒkshi, 49241
Jung Seop Eom, Site 0454, +82512407889
- Recruiting
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644
Ki Hyeong Lee, Site 0220, 82432696015
- Recruiting
Keimyung University Dongsan Hospital
Daegu, Taegu-Kwangyǒkshi, 42601
Keon Uk Park, Site 0490, 82532586671
- Recruiting
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, 41404
Shin Yup Lee, Site 0489, 82-10-6516-1694
- Recruiting
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408
Ji-Youn Han, Site 0201, +82319201154
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo, 58128
Young-Chul Kim, Site 0458, 821036352876
- Recruiting
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565
Eun Kyung Cho, Site 0234, 82324603383
- Recruiting
Cha Bundang Medical Center, Cha University
Seongnam-si, Kyǒnggi-do, 13496
Joo-Hang Kim, Site 0450, 82-2-2228-8131
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Hye Ryun Kim, Site 0175, 82222284190
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Dae Ho Lee, Site 0233, 82230103214
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Jin Seok Ahn, Site 0176, 821099333453
- Recruiting
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 08308
Sung Yong Lee, Site 0488, 821022179216
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Kyǒngsangnam-do, 50612
Seong Hoon Yoon, Site 0491, 82-10-2870-9389
Spain12 sites, 12 recruiting
- Recruiting
CHUAC-Hospital Teresa Herrera
A Coruña, A Coruña [La Coruña], 15006
Maria Rosario Garcia Campelo, Site 0270, 34981178353x292856
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Ilaria Priano, Site 0264, 34932746085
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041
Margarita Majem Tarruella, Site 0434, 34935565651
- Recruiting
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [Cataluña], 08908
NOELIA Vilarino Quintela, Site 0267, 34932275402
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
Pilar Garrido Lopez, Site 0413, (+34)913368263
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
Luis Paz-Ares Rodriguez, Site 0265, 0034913908922
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, 28222
Mariano Provencio Pulla, Site 0426, 34911917759
- Recruiting
H.R.U Málaga - Hospital General
Málaga, 29011
Manuel Cobo-Dols, Site 0266, 00349422033350000
- Recruiting
Hospital Son Llàtzer
Palma, Illes Balears [Islas Baleares], 07198
Juan Coves Sarto, Site 0414, 348712020001629
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Miriam Alonso Garcia, Site 0268, 34955013068
- Recruiting
Hospital Arnau de Vilanova
Valencia, València, 46015
Nuria Piera, Site 0411, 0034961976112
- Not yet recruiting
Local Institution - 0269
Valencia, 46026
Site 0269
United Kingdom12 sites, 6 recruiting
- Completed
Local Institution - 0349
Dundee, Dundee City, DD1 9SY
- Withdrawn
Local Institution - 0441
Exeter, Devon, EX2 5DW
- Not yet recruiting
Local Institution - 0189
Glasgow, Glasgow City, g12OYN
Site 0189
- Completed
Local Institution - 0271
Larbert, Falkirk, FK5 4WR
- Recruiting
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
Samreen Ahmed, Site 0026, 44 116 229 7246
- Withdrawn
Local Institution - 0021
London, Kensington and Chelsea, SW3 6JJ
- Recruiting
St Bartholomew's Hospital
London, London, City of, EC1A 7BE
Adam Januszewski, Site 0348, +44 20 7377 7000
- Not yet recruiting
Local Institution - 0001
London, London, City of, SE1 9RT
Site 0001
- Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
Anja Williams, Site 0464, 020 3219 5200
- Withdrawn
Local Institution - 0020
Manchester, M20 4BX
- Withdrawn
Local Institution - 0024
Metropolitan Borough of Wirral, CH63 4JY
- Recruiting
Royal Berkshire Hospital
Reading, RG1 5AN
Shawn Ellis, Site 0463, +44 118 322 5111
India11 sites, 11 recruiting
- Not yet recruiting
Local Institution - 0474
Badsa, Haryana, 124105
Site 0474
- Recruiting
Manipal Hospitals
Bengaluru, Karnataka, 560017
Amit Rauthan, Site 0333, 918025023407
- Recruiting
Narayana Superspecialty Hospital
Howrah, West Bengal, 711103
Chandrakanth MV, Site 0328, 7738519198
- Recruiting
Mumbai Oncocare Centre Vile Parle
Mumbai, Maharashtra, 400 057
Ashish Joshi, Site 0446, 9619597946
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Kumar Prabhash, Site 0336, 9167760576
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Prabhat Malik, Site 0329, 911129575232
- Not yet recruiting
Local Institution - 0448
New Delhi, National Capital Territory of Delhi, 110029
Site 0448
- Recruiting
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, 110085
Ullas Batra, Site 0337, 919711080001
- Recruiting
Yashoda Hospital
Secunderabad, Telangana, 500003
Bharat Ashok Vaswani, Site 0453, 040-67778999
- Recruiting
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, Kerala, 695011
Anoop Manoharan, Site 0331, 04712522653
- Not yet recruiting
Local Institution - 0476
Varanasi, Uttar Pradesh, 221005
Site 0476
Argentina9 sites, 9 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB
Lorena Lupinacci, Site 0219, 5411495902008159
- Not yet recruiting
Local Institution - 0493
Bariloche, Río Negro Province, 8400
Site 0493
- Recruiting
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280
Karina Vera, Site 0379, 1121571056
- Recruiting
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Claudio Martin, Site 0217, 5491166936669
- Recruiting
Hospital Privado Universitario de Córdoba
Córdoba, 5016
Jeremias Sierra, Site 0215, 543514862400
- Recruiting
Instituto Oncológico de Córdoba
Córdoba, X5000HWE
EDUARDO RICHARDET, Site 0370, 351-2325689
- Recruiting
Hospital Privado de Comunidad
Mar del Plata, 7600
Omar Carranza, Site 0236, 5422349900005823
- Recruiting
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, X5800AEV
Alejo Lingua, Site 0218, 54351153819050
- Recruiting
Sanatorio Parque
Rosario, Santa Fe Province, S2000DSV
Gaston Martinengo, Site 0216, 5493416955611
Australia8 sites, 8 recruiting
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 3128
Andrew Mant, Site 0054, 61398953281
- Recruiting
The Prince Charles Hospital
Brisbane, Queensland, 4032
Brett Hughes, Site 0243, 61736468111
- Recruiting
Gallipoli Medical Research Ltd
Brisbane, Queensland, 4120
Kenneth O'Byrne, Site 0068, 0731766505
- Not yet recruiting
Local Institution - 0057
Elizabeth Vale, South Australia, 5112
Site 0057
- Recruiting
Gosford Hospital
Gosford, New South Wales, 2250
Matthew Chan, Site 0058, +61243209890
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Lydia Warburton, Site 0053, 0000000000
- Recruiting
St. John of God Murdoch Hospital
Murdoch, Western Australia, 6150
Kynan Feeney, Site 0056, +61894389599
- Recruiting
GenesisCare North Shore
St Leonards, New South Wales, 2065
Nick Pavlakis, Site 0061, 61294631172
Netherlands8 sites, 3 recruiting
- Withdrawn
Local Institution - 0196
's-Hertogenbosch, North Brabant, 5223 GZ
- Recruiting
Ziekenhuis Rijnstate
Arnhem, 6815 AD
Niels Claessens, Site 0033, 31880056730
- Withdrawn
Local Institution - 0032
Groningen, 9700 RB
- Withdrawn
Local Institution - 0030
Harderwijk, Gelderland, 3844 DG
- Recruiting
Atrium-Orbis - Zuyderland Medisch Centrum Heerlen
Heerlen, Limburg, 6419 PC
Frank Custers, Site 0193, 31884597777
- Recruiting
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA
Egbert Smit, Site 0036, 31715262950
- Withdrawn
Local Institution - 0315
The Hague, South Holland, 2512 VA
- Withdrawn
Local Institution - 0195
Zwolle, Overijssel, 8025 AB
Poland8 sites, 7 recruiting
- Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Bogdan Zurawski, Site 0260, 48501446778
- Not yet recruiting
Local Institution - 0255
Konin, Greater Poland Voivodeship, 62-500
Site 0255
- Not yet recruiting
Local Institution - 0257
Koszalin, West Pomeranian Voivodeship, 75-581
Site 0257
- Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, 93-338
Ewa Kalinka, Site 0254, 530770073
- Recruiting
Centrum Medyczne Pratia Poznań
Poznan, Greater Poland Voivodeship, 60-192
Marek Kotlarski, Site 0256, 512491461
- Recruiting
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, 60-693
Rodryg Ramlau, Site 0261, 48618549040
- Recruiting
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty, 82-550
Anna Lowczak, Site 0258, +48503022396
- Withdrawn
Local Institution - 0259
Warsaw, Masovian Voivodeship, 04-125
Romania7 sites, 7 recruiting
- Recruiting
SC Memorial Healthcare International SRL
Bucharest, Bucharest, 013812
Ingrid Iordan, Site 0296, 40721298677
- Recruiting
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, Bucharest, 022338
Aurelia Alexandru, Site 0298, 40723289606
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Tudor Ciuleanu, Site 0301, 40745646368
- Recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542
Michael Schenker, Site 0295, 40727774974
- Recruiting
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280
Andrei Ungureanu, Site 0299, 40742206212
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Dana Clement, Site 0300, 40744692062
- Recruiting
Spitalul Municipal Schuller Ploiești
Ploieşti, 100337
Nita Amedeia, Site 0297, +40728121201
Belgium6 sites, 6 recruiting
- Recruiting
UZ Brussel
Brussels, Bruxelles-Capitale, Région de, 1090
Lore Decoster, Site 0039, 3224775457
- Recruiting
Antwerp University Hospital
Edegem, Antwerpen, 2650
Reinier Wener, Site 0396, 038215180
- Recruiting
Jessa Ziekenhuis
Hasselt, Limburg, 3500
Kristof Cuppens, Site 0187, +32472565987
- Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
Pierre FRERES, Site 0185, 003243237801
- Recruiting
AZ Delta vzw
Roeselare, West-Vlaanderen, 8800
Ingel Demedts, Site 0041, 3251237216
- Recruiting
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, Namur, 5530
Sebahat Ocak, Site 0038, 3281423351
Chile6 sites, 6 recruiting
- Recruiting
Orlandi Oncologia
Santiago, Santiago Metropolitan, 0
Francisco Orlandi, Site 0213, 56992214787
- Recruiting
Fundacion Arturo Lopez Perez (FALP)
Santiago, Santiago Metropolitan, 7500921
Christian Caglevic, Site 0249, 56224457254
- Recruiting
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330032
Hector Galindo, Site 0212, +56963413803
- Recruiting
Bradfordhill
Santiago, Santiago Metropolitan, 8420383
Carlos Rojas, Site 0214, +56998744662
- Recruiting
Instituto del Cancer Redsalud
Santiago, Vitacura, '7650018
Juan Pablo Miranda Olivares, Site 0495
- Recruiting
Oncocentro Apys
Viña del Mar, Valparaiso, 2520598
Alejandro Acevedo Gaete, Site 0452, +56992369820
Colombia6 sites, 5 recruiting
- Recruiting
Hospital Universitario San Ignacio
Bogotá, Bogota D.C., 0
July Russi Noguera, Site 0443, 575946161x2473
- Not yet recruiting
Local Institution - 0418
Bogotá, Bogota D.C., 110131
Site 0418
- Not yet recruiting
Local Institution - 0442
Cali, Valle del Cauca Department, 760032
Site 0442
- Recruiting
Instituto de Cancerología
Medellín, Antioquia, 0
Diego Gonzalez, Site 0415, 573206912418
- Recruiting
Oncologos del Occidente
Pereira, Risaralda Department, 660001
Gustavo Rojas-Uribe, Site 0416, 573155313926
- Withdrawn
Local Institution - 0417
Valledupar, Cesar Department, 200001
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Adana Medical Park Seyhan Hastanesi
Adana, 01140
Ahmet Taner Sumbul, Site 0361, 905056166338
- Recruiting
Adana City Hospital
Adana, 01370
Timucin Cil, Site 0365, 905331447619
- Recruiting
Hacettepe Universite Hastaneleri
Ankara, 06230
Mustafa Erman, Site 0383, +905334318506
- Recruiting
Ankara Bilkent Şehir Hastanesi
Ankara, 06800
Mehmet Ali Nahit Sendur, Site 0362, 905555306271
- Recruiting
Medipol Mega Universite Hastanesi
Istanbul, 34214
Ahmet Bilici, Site 0410, 905325280486
- Recruiting
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
Mahmut Gumus, Site 0364, 00905063509061
New Zealand5 sites, 4 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
Aileen Ludlow, Site 0405, 6493074949(Ext24512)
- Not yet recruiting
Local Institution - 0425
Dunedin, 9016
Site 0425
- Not yet recruiting
Local Institution - 0407
Tauranga, Bay of Plenty, 3112
Site 0407
- Completed
Local Institution - 0447
Tauranga, Bay of Plenty, 3112
- Not yet recruiting
Local Institution - 0406
Wellington, 6021
Site 0406
South Africa5 sites, 5 recruiting
- Recruiting
Cape Town Oncology Trials
Cape Town, Western Cape, 7570
Corlia Coetzee, Site 0428, 27219443832
- Recruiting
Wits Clinical Research
Johannesburg, GP, 2193
Georgia Demetriou, Site 0429, 27113390600
- Recruiting
Life Groenkloof
Pretoria, GP, 0181
Graham Cohen, Site 0432, 012 346 6701
- Recruiting
Sandton Oncology Medical Group (Pty) Ltd
Sandton, GP, 2196
Sze Chan, Site 0427, 27118830900
- Recruiting
Wits Clinical Research
Soweto, Gauteng, 2013
Rofhiwa Mathiba, Site 0431, 0834077151
Taiwan5 sites, 5 recruiting
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Chin-Chou Wang, Site 0445, 88677317123
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
Kang-Yun Lee, Site 0118, 8862224900882714
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
Tsung-Ying Yang, Site 0117, 8864235925253218
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Jin-Yuan Shih, Site 0116, 88622312345662905
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Yung-Hung Luo, Site 0119, 886921770588
Ireland4 sites, 3 recruiting
- Recruiting
St. James's Hospital
Dublin, D08 E9P6
Sinead Cuffe, Site 0367, 35314103756
- Recruiting
Beacon Hospital
Dublin, D18 AK68
Lisa Prior, Site 0028, +35312935666
- Recruiting
Tallaght University Hospital
Dublin, D24 NR0A
Sebastian Trainor, Site 0029, 0035314144299
- Withdrawn
Local Institution - 0027
Dublin, D9
Mexico4 sites, 4 recruiting
- Recruiting
Cancer Treamtent Clinic and Clinical Trials Sa de Cv
Guadalajara, Jalisco, 44260
Juan Vazquez Limon, Site 0170, 523316063096
- Recruiting
Arké SMO S.A. de C.V.
México, 06700
Eleazar Macedo Perez, Site 0172, 525533345856
- Recruiting
Hospital H+ Queretaro
Querétaro, 76000
Juan Feregrino, Site 0168, +524421145730
- Recruiting
Centro Potosino de Investigación Médica
San Luis Potosí City, 78250
Pedro Figueroa Martinez, Site 0169, 4444479873
Portugal4 sites, 4 recruiting
- Recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, 3040
Ana Figueiredo, Site 0404, 351966764837
- Recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Lisbon District, 1099-023
Telma Sequeira, Site 0402, 914000669
- Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Maria Cassiano Neves, Site 0403, 961760869
- Not yet recruiting
Local Institution - 0401
Porto, 4200-319
Site 0401
Switzerland4 sites, 1 recruiting
- Withdrawn
Local Institution - 0290
Basel, 4031
- Withdrawn
Local Institution - 0341
Bellinzona, Canton Ticino, 6500
- Not yet recruiting
Local Institution - 0291
Lausanne, Canton of Vaud, 1011
Site 0291
- Withdrawn
Local Institution - 0398
Münsterlingen, 8596
Austria3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Krems
Krems, Lower Austria, 3500
Klaus Hackner, Site 0314, 0273290044368
- Recruiting
Klinik Floridsdorf
Vienna, 1210
Maximilian Hochmair, Site 0293, +4319106041242
- Recruiting
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, 4600
Christian Trockenbacher, Site 0292, 4372424152382
Denmark3 sites, 2 recruiting
- Recruiting
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, 8200
Pernille Elming, Site 0198, +4524925948
- Completed
Local Institution - 0125
Copenhagen, Capital Region, 2100
- Recruiting
Sygehus Soenderjylland
Sønderborg, Region Syddanmark, 6400
Daniela Zitnjak, Site 0124, 79973114
Saudi Arabia3 sites, 3 recruiting
- Recruiting
King Fahad Specialist Hospital - Dammam
Dammam, Eastern Province, 31444
Waleed AlSelwi, Site 0440, +966541269703
- Recruiting
King Faisal Specialist Hospital
Jeddah, Makkah Al Mukarramah, 23433
Ahmed Allehebi, Site 0409, +966555558414
- Not yet recruiting
Local Institution - 0408
Riyadh, Riyadh Region, 11426
Site 0408
Canada1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0494
Montreal, Quebec, J4B6S4
Site 0494
About this study
Official title: A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Nivolumab, Relatlimab, Pembrolizumab, Carboplatin, Pemetrexed
- Keywords
- Non-squamous, PDL-1 ≥ 1%
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Specified dose on specified days
RelatlimabDrug
Specified dose on specified days
PembrolizumabDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin |
| Arm B | Active comparator | Not described Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Measured: Up to 5 years
Secondary outcomes (8)
OS in randomized participants with PD-L1 ≥ 1%
Measured: Up to 5 years
Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Measured: Up to 5 years
Overall response rate (ORR)
Measured: Up to 5 years
Duration of response (DoR)
Measured: Up to 5 years
Number of participants with adverse events (AEs)
Measured: Up to 2.5 years
Number of participants with serious adverse events (SAEs)
Measured: Up to 2.5 years
Number of participants with immune-mediated adverse events (IMAEs)
Measured: Up to 2.5 years
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start7 Oct 2024
- Primary completion30 Jul 2030 (estimated)
- Study completion4 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561386
- Sponsor's protocol ID
- CA224-1093
- Other IDs
- 2024-513682-40, U1111-1306-8896
- Acronym
- RELATIVITY1093
- Status last verified
- Oct 2026
- First submitted
- 16 Aug 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html