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
- Interventions
- 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
- NOT_YET_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
Trial Locations
- Locations (153)
Local Institution - 0335
🇨🇳Xi'an, Shaanxi, China
Local Institution - 0245
🇺🇸Fort Myers, Florida, United States
Local Institution - 0009
🇺🇸Orange City, Florida, United States
Local Institution - 0020
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0013
🇺🇸Marietta, Georgia, United States
Local Institution - 0037
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0033
🇺🇸Albuquerque, New Mexico, United States
Local Institution - 0029
🇺🇸Durham, North Carolina, United States
Local Institution - 0284
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0231
🇺🇸Sioux Falls, South Dakota, United States
Local Institution - 0307
🇺🇸Knoxville, Tennessee, United States
Local Institution - 0008
🇺🇸Nashville, Tennessee, United States
Local Institution - 0001
🇺🇸Austin, Texas, United States
Local Institution - 0281
🇺🇸Tyler, Texas, United States
Local Institution - 0246
🇺🇸Blacksburg, Virginia, United States
Local Institution - 0026
🇺🇸Seattle, Washington, United States
Local Institution - 0007
🇺🇸Tacoma, Washington, United States
Local Institution - 0079
🇦🇷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
Local Institution - 0080
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0094
🇦🇷Río Cuarto, Córdoba, Argentina
Local Institution - 0202
🇦🇺Campbelltown, New South Wales, Australia
Local Institution - 0106
🇦🇺Penrith, New South Wales, Australia
Local Institution - 0105
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0190
🇦🇺Ballarat Central, Victoria, Australia
Local Institution - 0175
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0251
🇦🇹Wels, Oberösterreich, Austria
Local Institution - 0253
🇦🇹Graz, Steiermark, Austria
Local Institution - 0252
🇦🇹Linz, Austria
Local Institution - 0255
🇦🇹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
Local Institution - 0290
🇨🇦Chicoutimi, Quebec, Canada
Local Institution - 0287
🇨🇦Rimouski, Quebec, Canada
Local Institution - 0288
🇨🇦Quebec, Canada
Local Institution - 0086
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0085
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0083
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0084
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0082
🇨🇱Viña del Mar, Valparaíso, Chile
Local Institution - 0203
🇨🇳Chongqing, Chongqing, China
Local Institution - 0114
🇨🇿Brno, Brno-město, Czechia
Local Institution - 0117
🇨🇿Ostrava, Ostrava Město, Czechia
Local Institution - 0113
🇨🇿Prague, Praha 4, Czechia
Local Institution - 0116
🇨🇿Olomouc, Czechia
Local Institution - 0048
🇫🇷Montpellier, Hérault, France
Local Institution - 0040
🇫🇷La Tronche, Isère, France
Local Institution - 0052
🇫🇷Lille, Nord-Pas-de-Calais, France
Local Institution - 0044
🇫🇷Gleize, Rhône, France
Local Institution - 0051
🇫🇷Pierre-Bénite, Rhône, France
Local Institution - 0047
🇫🇷Créteil, Val-de-Marne, France
Local Institution - 0038
🇫🇷Villejuif, Val-de-Marne, France
Local Institution - 0043
🇫🇷Marseille, France
Local Institution - 0050
🇫🇷Paris, France
Local Institution - 0215
🇫🇷Quimper, France
Local Institution - 0256
🇩🇪Frankfurt, Hessen, Germany
Local Institution - 0262
🇩🇪Oldenburg, Niedersachsen, Germany
Local Institution - 0261
🇩🇪Köln, Nordrhein-Westfalen, Germany
Local Institution - 0265
🇩🇪Halle, Sachsen-Anhalt, Germany
Local Institution - 0257
🇩🇪Bad Berka, Thüringen, Germany
Local Institution - 0263
🇩🇪Berlin, Germany
Local Institution - 0258
🇩🇪Gauting, Germany
Local Institution - 0259
🇩🇪Grosshansdorf, Germany
Local Institution - 0264
🇩🇪Stuttgart, Germany
Local Institution - 0063
🇬🇷Athens, Attikí, Greece
Local Institution - 0064
🇬🇷Athens, Attikí, Greece
Local Institution - 0062
🇬🇷Thessaloniki, Kentrikí Makedonía, Greece
Local Institution - 0058
🇬🇷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
Local Institution - 0072
🇮🇹Napoli, Campania, Italy
Local Institution - 0068
🇮🇹Milan, Lombardia, 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
🇮🇹Milano, Italy
Local Institution - 0319
🇯🇵Matsuyama, Ehime, Japan
Local Institution - 0292
🇯🇵Kurume, Fukuoka, Japan
Local Institution - 0313
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0323
🇯🇵Kobe, Hyogo, Japan
Local Institution - 0321
🇯🇵Kanazawa, Ishikawa, Japan
Local Institution - 0316
🇯🇵Yokohama, Kanagawa, Japan
Local Institution - 0291
🇯🇵Sendai, Miyagi, Japan
Local Institution - 0324
🇯🇵Kashihara, Nara, Japan
Local Institution - 0328
🇯🇵Kurashiki, Okayama, Japan
Local Institution - 0317
🇯🇵Hirakata, Osaka, Japan
Local Institution - 0314
🇯🇵Osakasayama, Osaka, Japan
Local Institution - 0325
🇯🇵Takatsuki, Osaka, Japan
Local Institution - 0320
🇯🇵Hidaka, Saitama, Japan
Local Institution - 0318
🇯🇵Ina-machi, Saitama, Japan
Local Institution - 0322
🇯🇵Hamamatsu, Shizuoka, Japan
Local Institution - 0326
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0315
🇯🇵Koto, Tokyo, Japan
Local Institution - 0327
🇯🇵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 - 0097
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0099
🇳🇱Arnhem, Netherlands
Local Institution - 0098
🇳🇱Groningen, Netherlands
Local Institution - 0192
🇵🇱Prabuty, Pomorskie, Poland
Local Institution - 0193
🇵🇱Konin, Wielkopolskie, Poland
Local Institution - 0241
🇵🇱Skorzewo, Wielkopolskie, Poland
Local Institution - 0195
🇵🇱Bydgoszcz, Poland
Local Institution - 0189
🇵🇱Łódź, Łódzkie, Poland
Local Institution - 0135
🇷🇴Bucuresti, București, Romania
Local Institution - 0137
🇷🇴Florești, Cluj, Romania
Local Institution - 0140
🇷🇴Craiova, Dolj, Romania
Local Institution - TEMP7289048470
🇷🇴Craiova, Dolj, Romania
Local Institution - 0133
🇷🇴București, Romania
Local Institution - 0141
🇷🇴Cluj, Romania
Local Institution - 0139
🇷🇴Iași, Romania
Local Institution - 0132
🇷🇴Iași, Romania
Local Institution - 0294
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0302
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0301
🇪🇸Jaen, Jaén, Spain
Local Institution - 0296
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0303
🇪🇸Valencia, Valenciana, Comunitat, Spain
Local Institution - 0248
🇨🇭Chur, Switzerland
Local Institution - 0249
🇨🇭Winterthur, Switzerland
Local Institution - 0247
🇨🇭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
Local Institution - 0101
🇬🇧Manchester, United Kingdom
Local Institution - 0226
🇬🇧Wirral, United Kingdom