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).
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Interventions
- Biological: BMS-986489 (BMS-986012+Nivolumab)
- Registration Number
- NCT06646276
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 530
- 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
- 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
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A BMS-986489 (BMS-986012+Nivolumab) - Arm A Carboplatin - Arm A Etoposide - Arm B Atezolizumab - Arm B Carboplatin - Arm B Etoposide -
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 5 years
- Secondary Outcome Measures
Name Time Method Time to definitive deterioration (TTDD)based on the LCSS ASBI defined as the time from randomization until a definitive clinically meaningful decline (≥ 10 point increase from baseline in LCSS ASBI score). Up to 5 years Number of participants with Adverse Events (AEs) Up to 135 days after last treatment Number of Participants with Serious Adverse Events (SAEs) Up to 135 days after last treatment Number of Participants with Adverse Events (AEs) leading to discontinuation and death Up to 135 days after last treatment Objective Response (OR) Up to 5 years Duration of Response (DOR) Up to 5 years Progression Free Survival (PFS) Up to 5 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (190)
Local Institution - 0337
🇺🇸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
🇺🇸Saint 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
Local Institution - 0029
🇺🇸Durham, North Carolina, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0239
🇺🇸Cleveland, Ohio, United States
Sanford Cancer Center
🇺🇸Sioux Falls, South Dakota, United States
Local Institution - 0307
🇺🇸Knoxville, Tennessee, 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 Medical Center
🇺🇸Seattle, Washington, United States
Local Institution - 0007
🇺🇸Tacoma, Washington, United States
Instituto Alexander Fleming
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0077
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0100
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Clinica Adventista Belgrano
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Córdoba, Argentina
GenesisCare - Campbelltown
🇦🇺Campbelltown, New South Wales, Australia
Local Institution - 0106
🇦🇺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
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Oberösterreich, Austria
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Kepler Universitätsklinikum
🇦🇹Linz, Austria
Landeskrankenhaus Rankweil
🇦🇹Rankweil, Austria
Local Institution - 0250
🇦🇹Wien, Austria
Local Institution - 0198
🇧🇪Brussels, Bruxelles-Capitale, Région De, Belgium
Local Institution - 0091
🇧🇪Gent, Oost-Vlaanderen, Belgium
Local Institution - 0187
🇧🇪Sint-Niklaas, Oost-Vlaanderen, Belgium
Local Institution - 0180
🇧🇪Leuven, Vlaams-Brabant, Belgium
Local Institution - 0092
🇧🇪Liège, Belgium
Local Institution - 0166
🇧🇷Fortaleza, Ceará, Brazil
Local Institution - 0165
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0169
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0170
🇧🇷Santa Cruz do Sul, Rio Grande Do Sul, Brazil
Local Institution - 0163
🇧🇷Itajaí, Santa Catarina, Brazil
Local Institution - 0178
🇧🇷Barretos, São Paulo, Brazil
Local Institution - 0111
🇧🇷Sao Paulo, São Paulo, Brazil
Local Institution - 0289
🇨🇦Edmonton, Alberta, Canada
CIUSSS- saguenay-Lac-Saint-Jean
🇨🇦Chicoutimi, Quebec, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
🇨🇦Rimouski, Quebec, Canada
IUCPQ
🇨🇦Quebec, Canada
Orlandi Oncologia
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Fundacion Arturo Lopez Perez (FALP)
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Pontificia Universidad Catolica de Chile
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Bradfordhill
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Oncocentro Apys
🇨🇱Viña del Mar, Valparaíso, Chile
Local Institution - 0204
🇨🇳Beijing, Beijing, China
Local Institution - 0336
🇨🇳Beijing, Beijing, China
Local Institution - 0203
🇨🇳Chongqing, Chongqing, China
Local Institution - 0308
🇨🇳Fuzhou, Fujian, China
Local Institution - 0212
🇨🇳Xiamen, Fujian, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Local Institution - 0227
🇨🇳Harbin, Heilongjiang, China
Local Institution - 0208
🇨🇳Wuhan, Hubei, China
Local Institution - 0209
🇨🇳Wuhan, Hubei, China
Local Institution - 0216
🇨🇳Changsha, Hunan, China
Local Institution - 0233
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0244
🇨🇳Changchun, Jilin, China
Local Institution - 0235
🇨🇳Shenyang, Liaoning, China
Local Institution - 0335
🇨🇳Xi'an, Shaanxi, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Local Institution - 0206
🇨🇳Shanghai, Shanghai, China
Local Institution - 0210
🇨🇳Shanghai, Shanghai, China
Local Institution - 0330
🇨🇳Chengdu, Sichuan, China
Local Institution - 0213
🇨🇳Tianjin, Tianjin, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0237
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0229
🇨🇳Linhai, Zhejiang, China
Shanghai East Hospital
🇨🇳Shanghai, China
Masarykuv onkologicky ustav
🇨🇿Brno, Brno-město, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s.
🇨🇿Ostrava, Ostrava Město, Czechia
Local Institution - 0113
🇨🇿Prague, Praha 4, Czechia
Local Institution - 0116
🇨🇿Olomouc, Czechia
Hôpital Arnaud de Villeneuve - CHU Montpellier
🇫🇷Montpellier, Hérault, France
Chu Grenoble Alpes
🇫🇷La Tronche, Isère, France
CHU Lille - Institut Coeur Poumon
🇫🇷Lille Cedex, Nord, France
L Hopital Nord Ouest
🇫🇷Gleize, 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
Institut für Klinisch Onkologische Forschung
🇩🇪Frankfurt, Hessen, Germany
Pius Hospital Oldenburg
🇩🇪Oldenburg, Niedersachsen, Germany
Klinikum Köln-Merheim
🇩🇪Köln, Nordrhein-Westfalen, Germany
Krankenhaus Martha-Maria Halle-Dölau
🇩🇪Halle, Sachsen-Anhalt, Germany
Local Institution - 0257
🇩🇪Bad Berka, Thüringen, Germany
Local Institution - 0263
🇩🇪Berlin, Germany
Asklepios Klinik Gauting GmbH
🇩🇪Gauting, Germany
LungenClinic Grosshansdorf
🇩🇪Grosshansdorf, Germany
Local Institution - 0260
🇩🇪Heidelberg, Germany
Robert Bosch Krankenhaus GmbH
🇩🇪Stuttgart, Germany
Errikos Dunant Hospital Center
🇬🇷Athens, Attikí, Greece
Local Institution - 0064
🇬🇷Athens, Attikí, Greece
Local Institution - 0062
🇬🇷Thessaloniki, Kentrikí Makedonía, Greece
European Interbalkan Medical Center
🇬🇷Thessaloniki, Thessaloníki, Greece
Local Institution - 0059
🇬🇷Larissa, Thessalía, Greece
Local Institution - 0278
🇮🇳New Delhi, Delhi, India
Local Institution - 0274
🇮🇳Bengaluru, Karnataka, India
Local Institution - 0271
🇮🇳Madurai, Tamil Nadu, India
Local Institution - 0277
🇮🇳Varanasi, Uttar Pradesh, India
Local Institution - 0273
🇮🇳Kolkata, West Bengal, India
Istituto Nazionale Tumori IRCCS Fondazione Pascale
🇮🇹Napoli, Campania, Italy
Local Institution - 0068
🇮🇹Milan, Lombardia, Italy
Istituto Nazionale Tumori Regina Elena
🇮🇹Rome, Roma, Italy
Local Institution - 0110
🇮🇹Perugia, Umbria, Italy
Casa di Cura Dott. Pederzoli
🇮🇹Peschiera del Garda, Verona, Italy
Local Institution - 0074
🇮🇹Bologna, Italy
Istituto Europeo di Oncologia IRCCS
🇮🇹Milano, 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-shi, Hyogo, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Yokohama, Kanagawa, Japan
Sendai Kousei Hospital
🇯🇵Sendai, Miyagi, Japan
Nara Medical University Hospital
🇯🇵Kashihara city, Nara, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki, Okayama, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Osaka, Japan
Local Institution - 0314
🇯🇵Osakasayama, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
Local Institution - 0318
🇯🇵Ina-machi, Saitama, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Local Institution - 0326
🇯🇵Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Koto, Tokyo, Japan
Fukushima Medical University
🇯🇵Fukushima, Japan
Local Institution - 0305
🇰🇷Cheongju-si, Chungcheongbuk-do [Chungbuk], Korea, Republic of
Local Institution - 0286
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Local Institution - 0304
🇰🇷Suwon-si, Kyǒnggi-do, Korea, Republic of
Local Institution - 0285
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0293
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0309
🇰🇷Daegu, Taegu-Kwangyǒkshi, Korea, Republic of
Local Institution - 0311
🇲🇾Kuching, Sarawak, Malaysia
Local Institution - 0310
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Local Institution - 0312
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Local Institution - 0148
🇲🇽Pachuca, Hidalgo, Mexico
Local Institution - 0146
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0147
🇲🇽Monterrey, Nuevo León, Mexico
Local Institution - 0145
🇲🇽Puebla, Mexico
Local Institution - 0097
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0099
🇳🇱Arnhem, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Szpital Specjalistyczny w Prabutach Spolka z o.o.
🇵🇱Prabuty, Pomorskie, Poland
Przychodnia Lekarska KOMED
🇵🇱Konin, Wielkopolskie, Poland
Pratia Poznań
🇵🇱Poznań, Wielkopolskie, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
🇵🇱Bydgoszcz, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Łódź, Łódzkie, Poland
SC Memorial Healthcare International SRL
🇷🇴Bucharest, București, Romania
Institutul Oncologic Bucuresti
🇷🇴Bucharest, București, Romania
SC Radiotherapy Center Cluj SRL
🇷🇴Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"
🇷🇴Craiova, Dolj, Romania
Institutul Oncologic Cluj
🇷🇴Cluj, Romania
S.C. Centrul de Oncologie Euroclinic S.R.L.
🇷🇴Iași, Romania
Institutul Regional de Oncologie
🇷🇴Iași, Romania
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
🇪🇸Jaen, 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
Local Institution - 0299
🇪🇸Sevilla, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Kantonsspital Graubünden
🇨🇭Chur, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
UniversitätsSpital Zürich
🇨🇭Zürich, Switzerland
Local Institution - 0158
🇹🇷Cigli, İzmir, Turkey
Local Institution - 0154
🇹🇷Adana, Turkey
Local Institution - 0157
🇹🇷Ankara, Turkey
Local Institution - 0177
🇹🇷Ankara, Turkey
Local Institution - 0153
🇹🇷Istanbul, Turkey
Local Institution - 0197
🇬🇧London, London, City Of, United Kingdom
Local Institution - 0183
🇬🇧Central Middlesbrough, Middlesbrough, United Kingdom
Local Institution - 0159
🇬🇧Aberdeen, United Kingdom
Local Institution - 0108
🇬🇧Leicester, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
The Clatterbridge Cancer Centre
🇬🇧Wirral, United Kingdom