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A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
Sponsor: Bristol-Myers Squibb
Summary
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
Official title: A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
530
Start Date
2025-02-25
Completion Date
2031-09-05
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
BMS-986489 (BMS-986012+Nivolumab)
Specified dose on specified days
Atezolizumab
Specified dose on specified days
Carboplatin
Specified dose on specified days
Etoposide
Specified dose on specified days
Locations (184)
Southern Cancer Center, PC
Daphne, Alabama, United States
Local Institution - 0283
Hot Springs, Arkansas, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
Illinois Cancer Care
Peoria, Illinois, United States
Local Institution - 0037
Minneapolis, Minnesota, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Duke Cancer Institute
Durham, North Carolina, United States
Local Institution - 0232
Bismarck, North Dakota, United States
Local Institution - 0010
Fargo, North Dakota, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Sanford Cancer Center
Sioux Falls, South Dakota, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas
Austin, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
Local Institution - 0100
Buenos Aires, Buenos Aires F.D., Argentina
Clinica Adventista Belgrano
CABA, Buenos Aires F.D., Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
GenesisCare - Campbelltown
Campbelltown, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Gallipoli Medical Research Ltd
Brisbane, Queensland, Australia
Grampians Health
Ballarat Central, Victoria, Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia, Australia
Medizinische Universität Graz
Graz, Styria, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria
Kepler Universitätsklinikum
Linz, Austria
Landeskrankenhaus Rankweil
Rankweil, Austria
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
VITAZ
Sint-Niklaas, Oost-Vlaanderen, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
Hospital São Carlos
Fortaleza, Ceará, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Clínica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
A. C. Camargo Cancer Center
São Paulo, São Paulo, Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
IUCPQ
Québec, Quebec, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
Rimouski, Quebec, Canada
Oncocentro Apys
Viña del Mar, Región de Valparaíso, Chile
Orlandi Oncologia
Santiago, Santiago Metropolitan, Chile
Fundacion Arturo Lopez Perez (FALP)
Santiago, Santiago Metropolitan, Chile
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
Bradfordhill
Santiago, Santiago Metropolitan, Chile
Peking University Cancer Hospital Beijing Cancer Hospital Beijing Institute for Cancer Research
Beijing, Beijing Municipality, China
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University
Xiamen, Fujian, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Wuhan Tongji Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Province Tumor Hospital
Changchun, Jilin, China
Local Institution - 0235
Shenyang, Liaoning, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China
Masarykuv onkologicky ustav
Brno, Brno-město, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, Ostrava Město, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault, France
Chu Grenoble Alpes
La Tronche, Isère, France
CHU Lille - Institut Coeur Poumon
Lille, Nord, France
L Hopital Nord Ouest
Gleizé, Rhône, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
Centre Hospitalier Intercommunal de Créteil
Créteil, Val-de-Marne, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, France
Institut Curie
Paris, France
Centre Hospitalier de Cornouaille Quimper - Concarneau
Quimper, France
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, Germany
Pius Hospital Oldenburg
Oldenburg, Lower Saxony, Germany
Klinikum Köln-Merheim
Cologne, North Rhine-Westphalia, Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, Saxony-Anhalt, Germany
Zentralklinik Bad Berka
Bad Berka, Thuringia, Germany
Asklepios Klinik Gauting GmbH
Gauting, Germany
LungenClinic Grosshansdorf
Großhansdorf, Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Germany
Robert Bosch Krankenhaus GmbH
Stuttgart, Germany
Errikos Dunant Hospital Center
Athens, Attikí, Greece
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí, Greece
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, Greece
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, Greece
University General Hospital of Larissa
Larissa, Thessalía, Greece
Manipal Hospitals
Bengaluru, Karnataka, India
Local Institution - 0278
New Delhi, National Capital Territory of Delhi, India
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, India
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Varanasi, Uttar Pradesh, India
Netaji Subhas Chandra Bose Cancer Hospital
Kolkata, West Bengal, India
Local Institution - 0072
Naples, Campania, Italy
Local Institution - 0068
Milan, Lombardy, Italy
Local Institution - 0069
Rome, Roma, Italy
Local Institution - 0110
Perugia, Umbria, Italy
Local Institution - 0070
Peschiera del Garda, Verona, Italy
Local Institution - 0074
Bologna, Italy
Local Institution - 0067
Milan, Italy
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Saitama Prefectural Cancer Center
Ina-machi, Saitama, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Fukushima Medical University
Fukushima, Japan
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Centro Inmuno-Oncología Occidente
Guadalajara, Jalisco, Mexico
Local Institution - 0147
Monterrey, Nuevo León, Mexico
Unidad Médica Onco-hematológica
Puebla City, Mexico
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Przychodnia Lekarska KOMED
Konin, Greater Poland Voivodeship, Poland
Centrum Medyczne Pratia Poznań
Poznan, Greater Poland Voivodeship, Poland
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty, Pomeranian Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
SC Memorial Healthcare International SRL
Bucharest, București, Romania
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, București, Romania
SC Radiotherapy Center Cluj SRL
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, Romania
Institutul Regional de Oncologie
Iași, Romania
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Keimyung University Dongsan Hospital
Daegu, Taegu-Kwangyǒkshi, South Korea
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [La Coruña], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario de Jaen
Jaén, Jaén, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, Spain
Hospital General Universitario de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Kantonsspital Graubünden
Chur, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
UniversitätsSpital Zürich
Zurich, Switzerland
T.C. Saglik Bakanligi - Izmir Il Saglik Mudurlugu Cigli Bolge Egitim Hastanesi
Çiğli, İzmir, Turkey (Türkiye)
Adana City Hospital
Adana, Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi
Ankara, Turkey (Türkiye)
Istanbul Medeniyet University
Istanbul, Turkey (Türkiye)
James Cook University Hospital
Central Middlesbrough, Middlesbrough, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom