Clinical trial NCT06646276: 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).
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Extensive-Stage Small Cell Lung Cancer
Keywords: BMS-986489
BMS-986012
Extensive-Stage Small Cell Lung Cancer
Etoposide
Carboplatin
Nivolumab
TIGOS
fucGM1
SCLC
ES-SCLC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: 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).
timeFrame: Up to 5 years
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 135 days after last treatment
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 135 days after last treatment
measure: Number of Participants with Adverse Events (AEs) leading to discontinuation and death
timeFrame: Up to 135 days after last treatment
measure: Objective Response (OR)
timeFrame: Up to 5 years
measure: Duration of Response (DOR)
timeFrame: Up to 5 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Local Institution - 0337
state: Alabama
city: Hot Springs
country: United States
facility: Local Institution - 0283
state: Arkansas
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
state: Georgia
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Minneapolis
country: United States
facility: Local Institution - 0037
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Durham
country: United States
facility: Local Institution - 0029
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0239
state: Ohio
city: Sioux Falls
country: United States
facility: Sanford Cancer Center
state: South Dakota
city: Knoxville
country: United States
facility: Local Institution - 0307
state: Tennessee
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Central/South Texas
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas
state: Texas
city: Roanoke
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: Local Institution - 0007
state: Washington
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
state: Buenos Aires
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0100
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: Clinica Adventista Belgrano
state: Ciudad Autónoma De Buenos Aires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Campbelltown
country: Australia
facility: GenesisCare - Campbelltown
state: New South Wales
city: Penrith
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Gallipoli Medical Research Ltd
state: Queensland
city: Ballarat Central
country: Australia
facility: Grampians Health
state: Victoria
city: Murdoch
country: Australia
facility: St. John of God Murdoch Hospital
state: Western Australia
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Oberösterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Rankweil
country: Austria
facility: Landeskrankenhaus Rankweil
city: Wien
country: Austria
facility: Local Institution - 0250
city: Brussels
country: Belgium
facility: Local Institution - 0198
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: Local Institution - 0091
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Local Institution - 0187
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Local Institution - 0180
state: Vlaams-Brabant
city: Liège
country: Belgium
facility: Local Institution - 0092
city: Fortaleza
country: Brazil
facility: Local Institution - 0166
state: Ceará
city: Porto Alegre
country: Brazil
facility: Local Institution - 0165
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution - 0169
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Local Institution - 0170
state: Rio Grande Do Sul
city: Itajaí
country: Brazil
facility: Local Institution - 0163
state: Santa Catarina
city: Barretos
country: Brazil
facility: Local Institution - 0178
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0111
state: São Paulo
city: Edmonton
country: Canada
facility: Local Institution - 0289
state: Alberta
city: Chicoutimi
country: Canada
facility: CIUSSS- saguenay-Lac-Saint-Jean
state: Quebec
city: Rimouski
country: Canada
facility: Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
state: Quebec
city: Quebec
country: Canada
facility: IUCPQ
city: Santiago
country: Chile
facility: Orlandi Oncologia
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez (FALP)
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Bradfordhill
state: Región Metropolitana De Santiago
city: Viña del Mar
country: Chile
facility: Oncocentro Apys
state: Valparaíso
city: Beijing
country: China
facility: Local Institution - 0204
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0336
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Local Institution - 0308
state: Fujian
city: Xiamen
country: China
facility: Local Institution - 0212
state: Fujian
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
city: Harbin
country: China
facility: Local Institution - 0227
state: Heilongjiang
city: Wuhan
country: China
facility: Local Institution - 0208
state: Hubei
city: Wuhan
country: China
facility: Local Institution - 0209
state: Hubei
city: Changsha
country: China
facility: Local Institution - 0216
state: Hunan
city: Nanchang
country: China
facility: Local Institution - 0233
state: Jiangxi
city: Changchun
country: China
facility: Local Institution - 0244
state: Jilin
city: Shenyang
country: China
facility: Local Institution - 0235
state: Liaoning
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0206
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0210
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer hospital
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0213
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0237
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
state: Brno-město
city: Ostrava
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.
state: Ostrava Město
city: Prague
country: Czechia
facility: Local Institution - 0113
state: Praha 4
city: Olomouc
country: Czechia
facility: Local Institution - 0116
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU Montpellier
state: Hérault
city: La Tronche
country: France
facility: Chu Grenoble Alpes
state: Isère
city: Lille Cedex
country: France
facility: CHU Lille - Institut Coeur Poumon
state: Nord
city: Gleize
country: France
facility: L Hopital Nord Ouest
state: Rhône
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhône
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
state: Val-de-Marne
city: Villejuif
country: France
facility: Gustave Roussy
state: Val-de-Marne
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord
city: Paris
country: France
facility: Institut Curie
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille Quimper - Concarneau
city: Frankfurt
country: Germany
facility: Institut für Klinisch Onkologische Forschung
state: Hessen
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
state: Niedersachsen
city: Köln
country: Germany
facility: Klinikum Köln-Merheim
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau
state: Sachsen-Anhalt
city: Bad Berka
country: Germany
facility: Local Institution - 0257
state: Thüringen
city: Berlin
country: Germany
facility: Local Institution - 0263
city: Gauting
country: Germany
facility: Asklepios Klinik Gauting GmbH
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Heidelberg
country: Germany
facility: Local Institution - 0260
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus GmbH
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center
state: Attikí
city: Athens
country: Greece
facility: Local Institution - 0064
state: Attikí
city: Thessaloniki
country: Greece
facility: Local Institution - 0062
state: Kentrikí Makedonía
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
state: Thessaloníki
city: Larissa
country: Greece
facility: Local Institution - 0059
state: Thessalía
city: New Delhi
country: India
facility: Local Institution - 0278
state: Delhi
city: Bengaluru
country: India
facility: Local Institution - 0274
state: Karnataka
city: Madurai
country: India
facility: Local Institution - 0271
state: Tamil Nadu
city: Varanasi
country: India
facility: Local Institution - 0277
state: Uttar Pradesh
city: Kolkata
country: India
facility: Local Institution - 0273
state: West Bengal
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
state: Campania
city: Milan
country: Italy
facility: Local Institution - 0068
state: Lombardia
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
state: Roma
city: Perugia
country: Italy
facility: Local Institution - 0110
state: Umbria
city: Peschiera del Garda
country: Italy
facility: Casa di Cura Dott. Pederzoli
state: Verona
city: Bologna
country: Italy
facility: Local Institution - 0074
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Kashihara city
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osakasayama
country: Japan
facility: Local Institution - 0314
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Ina-machi
country: Japan
facility: Local Institution - 0318
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Koto
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University
city: Cheongju-si
country: Korea, Republic of
facility: Local Institution - 0305
state: Chungcheongbuk-do [Chungbuk]
city: Seongnam
country: Korea, Republic of
facility: Local Institution - 0286
state: Kyǒnggi-do
city: Suwon-si
country: Korea, Republic of
facility: Local Institution - 0304
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0285
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0293
state: Seoul-teukbyeolsi [Seoul]
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0309
state: Taegu-Kwangyǒkshi
city: Kuching
country: Malaysia
facility: Local Institution - 0311
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Local Institution - 0310
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Local Institution - 0312
state: Wilayah Persekutuan Kuala Lumpur
city: Pachuca
country: Mexico
facility: Local Institution - 0148
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Local Institution - 0146
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0147
state: Nuevo León
city: Puebla
country: Mexico
facility: Local Institution - 0145
city: Amsterdam
country: Netherlands
facility: Local Institution - 0097
state: Noord-Holland
city: Arnhem
country: Netherlands
facility: Local Institution - 0099
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Spolka z o.o.
state: Pomorskie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED
state: Wielkopolskie
city: Poznań
country: Poland
facility: Pratia Poznań
state: Wielkopolskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka
city: Łódź
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
state: Łódzkie
city: Bucharest
country: Romania
facility: SC Memorial Healthcare International SRL
state: București
city: Bucharest
country: Romania
facility: Institutul Oncologic Bucuresti
state: București
city: Florești
country: Romania
facility: SC Radiotherapy Center Cluj SRL
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"
state: Dolj
city: Cluj
country: Romania
facility: Institutul Oncologic Cluj
city: Iași
country: Romania
facility: S.C. Centrul de Oncologie Euroclinic S.R.L.
city: Iași
country: Romania
facility: Institutul Regional de Oncologie
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: A Coruña [La Coruña]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya [Cataluña]
city: Jaen
country: Spain
facility: Hospital Universitario de Jaen
state: Jaén
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad De
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Valenciana, Comunitat
city: Sevilla
country: Spain
facility: Local Institution - 0299
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Cigli
country: Turkey
facility: Local Institution - 0158
state: İzmir
city: Adana
country: Turkey
facility: Local Institution - 0154
city: Ankara
country: Turkey
facility: Local Institution - 0157
city: Ankara
country: Turkey
facility: Local Institution - 0177
city: Istanbul
country: Turkey
facility: Local Institution - 0153
city: London
country: United Kingdom
facility: Local Institution - 0197
state: London, City Of
city: Central Middlesbrough
country: United Kingdom
facility: Local Institution - 0183
state: Middlesbrough
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Leicester
country: United Kingdom
facility: Local Institution - 0108
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: