RecruitingRecruiting
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).
NCT06646276 · Bristol-Myers Squibb
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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).
About this study
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 criteria
Inclusion Criteria
* 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 Criteria
* 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
Enrollment target: 530 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-02-25
Estimated completion: 2031-09-05
Last updated: 2026-07-20
Interventions
Biological: BMS-986489 (BMS-986012+Nivolumab)Biological: AtezolizumabDrug: CarboplatinDrug: Etoposide
Primary outcomes
- • Overall Survival (OS) (Up to 5 years)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (183)
Southern Cancer Center, PCRecruiting
Daphne, Alabama, United States
Local Institution - 0283Completed
Hot Springs, Arkansas, United States
Florida Cancer Specialists - SouthRecruiting
Fort Myers, Florida, United States
Mid Florida Hematology and Oncology CenterRecruiting
Orange City, Florida, United States
Florida Cancer Specialists - NorthRecruiting
St. Petersburg, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalRecruiting
Marietta, Georgia, United States
Illinois Cancer CareRecruiting
Peoria, Illinois, United States
Local Institution - 0037Withdrawn
Minneapolis, Minnesota, United States
University of New Mexico Comprehensive Cancer CenterRecruiting
Albuquerque, New Mexico, United States
Duke Cancer InstituteRecruiting
Durham, North Carolina, United States
Sanford Medical CenterRecruiting
Bismarck, North Dakota, United States
Sanford Fargo Medical CenterRecruiting
Fargo, North Dakota, United States
Oncology Hematology CareRecruiting
Cincinnati, Ohio, United States
Sanford Cancer CenterRecruiting
Sioux Falls, South Dakota, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology - Central/South TexasRecruiting
Austin, Texas, United States
Texas Oncology - Northeast TexasRecruiting
Tyler, Texas, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.Recruiting
Roanoke, Virginia, United States
Swedish Cancer Institute - EdmondsRecruiting
Edmonds, Washington, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Local Institution - 0079Completed
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0077Completed
ABB, Buenos Aires F.D., Argentina
Local Institution - 0100Withdrawn
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0080Active Not Recruiting
CABA, Buenos Aires F.D., Argentina
Local Institution - 0094Active Not Recruiting
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0202Active Not Recruiting
Campbelltown, New South Wales, Australia
Local Institution - 0106Active Not Recruiting
Penrith, New South Wales, Australia
Local Institution - 0105Active Not Recruiting
Brisbane, Queensland, Australia
Local Institution - 0190Completed
Ballarat Central, Victoria, Australia
Local Institution - 0175Active Not Recruiting
Murdoch, Western Australia, Australia
Local Institution - 0253Active Not Recruiting
Graz, Styria, Austria
Local Institution - 0251Active Not Recruiting
Wels, Upper Austria, Austria
Local Institution - 0252Active Not Recruiting
Linz, Austria
Local Institution - 0255Active Not Recruiting
Rankweil, Austria
Local Institution - 0198Active Not Recruiting
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0091Active Not Recruiting
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0187Active Not Recruiting
Sint-Niklaas, Oost-Vlaanderen, Belgium
Local Institution - 0092Active Not Recruiting
Liège, Belgium
Local Institution - 0166Active Not Recruiting
Fortaleza, Ceará, Brazil
Local Institution - 0165Active Not Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0169Active Not Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0170Completed
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Local Institution - 0163Active Not Recruiting
Itajaí, Santa Catarina, Brazil
Local Institution - 0178Active Not Recruiting
Barretos, São Paulo, Brazil
Local Institution - 0111Active Not Recruiting
São Paulo, São Paulo, Brazil
Local Institution - 0289Active Not Recruiting
Edmonton, Alberta, Canada
Local Institution - 0290Active Not Recruiting
Chicoutimi, Quebec, Canada
Local Institution - 0288Active Not Recruiting
Québec, Quebec, Canada
Local Institution - 0287Active Not Recruiting
Rimouski, Quebec, Canada
Local Institution - 0086Active Not Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0085Active Not Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0083Completed
Santiago, Santiago Metropolitan, Chile
Local Institution - 0084Active Not Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0082Active Not Recruiting
Viña del Mar, Valparaiso, Chile
Local Institution - 0204Completed
Beijing, Beijing Municipality, China
Local Institution - 0336Active Not Recruiting
Beijing, Beijing Municipality, China
Local Institution - 0203Active Not Recruiting
Chongqing, Chongqing Municipality, China
Local Institution - 0308Active Not Recruiting
Fuzhou, Fujian, China
Local Institution - 0212Completed
Xiamen, Fujian, China
Local Institution - 0234Active Not Recruiting
Shantou, Guangdong, China
Local Institution - 0227Active Not Recruiting
Harbin, Heilongjiang, China
Local Institution - 0209Active Not Recruiting
Wuhan, Hubei, China
Local Institution - 0208Active Not Recruiting
Wuhan, Hubei, China
Local Institution - 0216Active Not Recruiting
Changsha, Hunan, China
Local Institution - 0233Active Not Recruiting
Nanchang, Jiangxi, China
Local Institution - 0244Active Not Recruiting
Changchun, Jilin, China
Local Institution - 0235Not Yet Recruiting
Shenyang, Liaoning, China
Local Institution - 0335Completed
Xi'an, Shaanxi, China
Local Institution - 0200Active Not Recruiting
Jinan, Shandong, China
Local Institution - 0206Active Not Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0210Active Not Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0186Active Not Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0330Active Not Recruiting
Chengdu, Sichuan, China
Local Institution - 0213Active Not Recruiting
Tianjin, Tianjin Municipality, China
Local Institution - 0236Active Not Recruiting
Hangzhou, Zhejiang, China
Local Institution - 0237Active Not Recruiting
Hangzhou, Zhejiang, China
Local Institution - 0229Active Not Recruiting
Linhai, Zhejiang, China
Local Institution - 0114Active Not Recruiting
Brno, Brno-město, Czechia
Local Institution - 0117Active Not Recruiting
Ostrava, Ostrava Město, Czechia
Local Institution - 0113Active Not Recruiting
Prague, Praha 4, Czechia
Local Institution - 0116Active Not Recruiting
Olomouc, Czechia
Local Institution - 0048Completed
Montpellier, Hérault, France
Local Institution - 0040Active Not Recruiting
La Tronche, Isère, France
Local Institution - 0052Completed
Lille, Nord, France
Local Institution - 0044Completed
Gleizé, Rhône, France
Local Institution - 0051Active Not Recruiting
Pierre-Bénite, Rhône, France
Local Institution - 0047Completed
Créteil, Val-de-Marne, France
Local Institution - 0038Active Not Recruiting
Villejuif, Val-de-Marne, France
Local Institution - 0043Active Not Recruiting
Marseille, France
Local Institution - 0050Active Not Recruiting
Paris, France
Local Institution - 0215Active Not Recruiting
Quimper, France
Local Institution - 0256Active Not Recruiting
Frankfurt am Main, Hesse, Germany
Local Institution - 0262Active Not Recruiting
Oldenburg, Lower Saxony, Germany
Local Institution - 0261Active Not Recruiting
Cologne, North Rhine-Westphalia, Germany
Local Institution - 0265Active Not Recruiting
Halle, Saxony-Anhalt, Germany
Local Institution - 0257Active Not Recruiting
Bad Berka, Thuringia, Germany
Local Institution - 0258Completed
Gauting, Germany
Local Institution - 0259Active Not Recruiting
Großhansdorf, Germany
Thoraxklinik-Heidelberg gGmbHRecruiting
Heidelberg, Germany
Local Institution - 0264Active Not Recruiting
Stuttgart, Germany
Local Institution - 0063Active Not Recruiting
Athens, Attikí, Greece
Local Institution - 0064Active Not Recruiting
Athens, Attikí, Greece
Local Institution - 0062Completed
Thessaloniki, Kentrikí Makedonía, Greece
Local Institution - 0058Active Not Recruiting
Thessaloniki, Thessaloníki, Greece
Local Institution - 0059Completed
Larissa, Thessalía, Greece
Local Institution - 0274Active Not Recruiting
Bengaluru, Karnataka, India
Local Institution - 0278Withdrawn
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0271Active Not Recruiting
Madurai, Tamil Nadu, India
Local Institution - 0277Active Not Recruiting
Varanasi, Uttar Pradesh, India
Local Institution - 0273Active Not Recruiting
Kolkata, West Bengal, India
Local Institution - 0072Active Not Recruiting
Naples, Campania, Italy
Local Institution - 0068Active Not Recruiting
Milan, Lombardy, Italy
Local Institution - 0069Active Not Recruiting
Rome, Roma, Italy
Local Institution - 0110Active Not Recruiting
Perugia, Umbria, Italy
Local Institution - 0070Active Not Recruiting
Peschiera del Garda, Verona, Italy
Local Institution - 0074Active Not Recruiting
Bologna, Italy
Local Institution - 0067Active Not Recruiting
Milan, Italy
Local Institution - 0319Active Not Recruiting
Matsuyama, Ehime, Japan
Local Institution - 0292Active Not Recruiting
Kurume, Fukuoka, Japan
Local Institution - 0313Active Not Recruiting
Sapporo, Hokkaido, Japan
Local Institution - 0323Active Not Recruiting
Kobe, Hyōgo, Japan
Local Institution - 0321Active Not Recruiting
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0316Completed
Yokohama, Kanagawa, Japan
Local Institution - 0291Active Not Recruiting
Sendai, Miyagi, Japan
Local Institution - 0324Completed
Kashihara, Nara, Japan
Local Institution - 0328Active Not Recruiting
Kurashiki, Okayama-ken, Japan
Local Institution - 0317Active Not Recruiting
Hirakata, Osaka, Japan
Local Institution - 0314Active Not Recruiting
Ōsaka-sayama, Osaka, Japan
Local Institution - 0325Completed
Takatsuki, Osaka, Japan
Local Institution - 0320Active Not Recruiting
Hidaka, Saitama, Japan
Local Institution - 0318Active Not Recruiting
Ina-machi, Saitama, Japan
Local Institution - 0322Active Not Recruiting
Hamamatsu, Shizuoka, Japan
Local Institution - 0326Active Not Recruiting
Bunkyo-ku, Tokyo, Japan
Local Institution - 0315Active Not Recruiting
Koto, Tokyo, Japan
Local Institution - 0327Active Not Recruiting
Fukushima, Japan
Hospital Kuala LumpurRecruiting
Kuala Lumpur, Kuala Lumpur, Malaysia
Local Institution - 0312Completed
Kuala Lumpur, Kuala Lumpur, Malaysia
Local Institution - 0311Active Not Recruiting
Kuching, Sarawak, Malaysia
Local Institution - 0146Active Not Recruiting
Guadalajara, Jalisco, Mexico
Local Institution - 0145Completed
Puebla City, Mexico
Local Institution - 0097Completed
Amsterdam, North Holland, Netherlands
Local Institution - 0099Active Not Recruiting
Arnhem, Netherlands
Local Institution - 0098Active Not Recruiting
Groningen, Netherlands
Local Institution - 0193Active Not Recruiting
Konin, Greater Poland Voivodeship, Poland
Local Institution - 0241Active Not Recruiting
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0192Active Not Recruiting
Prabuty, Pomeranian Voivodeship, Poland
Local Institution - 0195Active Not Recruiting
Bydgoszcz, Poland
Local Institution - 0189Active Not Recruiting
Lodz, Łódź Voivodeship, Poland
Local Institution - 0133Active Not Recruiting
Bucharest, Bucharest, Romania
Local Institution - 0135Active Not Recruiting
Bucharest, Bucharest, Romania
Local Institution - 0137Active Not Recruiting
Florești, Cluj, Romania
Local Institution - 0140Active Not Recruiting
Craiova, Dolj, Romania
Local Institution - 0141Active Not Recruiting
Cluj-Napoca, Romania
S.C. Centrul de Oncologie Euroclinic S.R.L.Recruiting
Iași, Romania
Institutul Regional de OncologieRecruiting
Iași, Romania
Local Institution - 0305Active Not Recruiting
Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea
Local Institution - 0286Active Not Recruiting
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0304Active Not Recruiting
Suwon, Kyǒnggi-do, South Korea
Local Institution - 0285Active Not Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0293Active Not Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0309Active Not Recruiting
Daegu, Taegu-Kwangyǒkshi, South Korea
Local Institution - 0300Active Not Recruiting
Santiago de Compostela, A Coruña [La Coruña], Spain
Local Institution - 0294Completed
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0302Active Not Recruiting
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0301Active Not Recruiting
Jaén, Jaén, Spain
Local Institution - 0298Active Not Recruiting
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0296Active Not Recruiting
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0297Active Not Recruiting
Majadahonda, Madrid, Comunidad de, Spain
Local Institution - 0303Completed
Valencia, Valenciana, Comunitat, Spain
Local Institution - 0299Active Not Recruiting
Seville, Spain
Local Institution - 0295Completed
Seville, Spain
Local Institution - 0248Active Not Recruiting
Chur, Switzerland
Local Institution - 0249Active Not Recruiting
Winterthur, Switzerland
Local Institution - 0247Active Not Recruiting
Zurich, Switzerland
Local Institution - 0158Active Not Recruiting
Çiğli, İzmir, Turkey (Türkiye)
Local Institution - 0154Active Not Recruiting
Adana, Turkey (Türkiye)
Local Institution - 0157Active Not Recruiting
Ankara, Turkey (Türkiye)
Local Institution - 0177Active Not Recruiting
Ankara, Turkey (Türkiye)
Local Institution - 0153Active Not Recruiting
Istanbul, Turkey (Türkiye)
Local Institution - 0183Completed
Central Middlesbrough, Middlesbrough, United Kingdom
Local Institution - 0159Completed
Aberdeen, United Kingdom
Local Institution - 0101Active Not Recruiting
Manchester, United Kingdom
Local Institution - 0226Active Not Recruiting
Metropolitan Borough of Wirral, United Kingdom