RecruitingPhase 3NCT06646276

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).

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).

Sponsor

Bristol-Myers Squibb

Enrollment

530 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system

Exclusion Criteria2

Participants have already received certain types of treatment for extensive stage small cell lung cancer
Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy

Interventions

BIOLOGICALBMS-986489 (BMS-986012+Nivolumab)

Specified dose on specified days

BIOLOGICALAtezolizumab

Specified dose on specified days

DRUGCarboplatin

Specified dose on specified days

DRUGEtoposide

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

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, Campania, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Istituto Nazionale Tumori Regina Elena

Rome, Roma, Italy

AO Santa Maria della Misericordia

Perugia, Umbria, Italy

Casa di Cura Dott. Pederzoli

Peschiera del Garda, Verona, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, Italy

Istituto Europeo di Oncologia IRCCS

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

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NCT06646276