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).

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.

Study Overview

• Status: Recruiting
• Conditions: Extensive-Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Etoposide; Biological: BMS-986489 (BMS-986012+Nivolumab); Biological: Atezolizumab

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
      • Completed
      • Local Institution - 0079
  • Buenos Aires F.D.
    • ABB, Buenos Aires F.D., Argentina, C1199ABB
      • Active, not recruiting
      • Local Institution - 0077
    • Buenos Aires, Buenos Aires F.D., Argentina, C1417DTB
      • Withdrawn
      • Local Institution - 0100
    • CABA, Buenos Aires F.D., Argentina, C1430EGF
      • Active, not recruiting
      • Local Institution - 0080
  • Córdoba Province
    • Río Cuarto, Córdoba Province, Argentina, X5800AEV
      • Active, not recruiting
      • Local Institution - 0094
• Australia
  • New South Wales
    • Campbelltown, New South Wales, Australia, 2560
      • Active, not recruiting
      • Local Institution - 0202
    • Penrith, New South Wales, Australia, 2750
      • Active, not recruiting
      • Local Institution - 0106
  • Queensland
    • Brisbane, Queensland, Australia, 4120
      • Active, not recruiting
      • Local Institution - 0105
  • Victoria
    • Ballarat Central, Victoria, Australia, 3350
      • Active, not recruiting
      • Local Institution - 0190
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Active, not recruiting
      • Local Institution - 0175
• Austria
  • Linz, Austria, 4021
    • Active, not recruiting
    • Local Institution - 0252
  • Rankweil, Austria, 6830
    • Active, not recruiting
    • Local Institution - 0255
  • Styria
    • Graz, Styria, Austria, 8036
      • Active, not recruiting
      • Local Institution - 0253
  • Upper Austria
    • Wels, Upper Austria, Austria, 4600
      • Active, not recruiting
      • Local Institution - 0251
• Belgium
  • Liège, Belgium, 4000
    • Active, not recruiting
    • Local Institution - 0092
  • Bruxelles-Capitale, Région de
    • Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
      • Active, not recruiting
      • Local Institution - 0198
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Active, not recruiting
      • Local Institution - 0091
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
      • Active, not recruiting
      • Local Institution - 0187
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60135-237
      • Active, not recruiting
      • Local Institution - 0166
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Active, not recruiting
      • Local Institution - 0165
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Active, not recruiting
      • Local Institution - 0169
    • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96830-180
      • Completed
      • Local Institution - 0170
  • Santa Catarina
    • Itajaí, Santa Catarina, Brazil, 88301-220
      • Active, not recruiting
      • Local Institution - 0163
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784400
      • Active, not recruiting
      • Local Institution - 0178
    • São Paulo, São Paulo, Brazil, 01509-010
      • Active, not recruiting
      • Local Institution - 0111
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Active, not recruiting
      • Local Institution - 0289
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Active, not recruiting
      • Local Institution - 0290
    • Québec, Quebec, Canada, G1V 4G5
      • Active, not recruiting
      • Local Institution - 0288
    • Rimouski, Quebec, Canada, G5L 5T1
      • Active, not recruiting
      • Local Institution - 0287
• Chile
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile
      • Active, not recruiting
      • Local Institution - 0086
    • Santiago, Santiago Metropolitan, Chile, 7500921
      • Active, not recruiting
      • Local Institution - 0085
    • Santiago, Santiago Metropolitan, Chile, 8330032
      • Active, not recruiting
      • Local Institution - 0083
    • Santiago, Santiago Metropolitan, Chile, 8420383
      • Active, not recruiting
      • Local Institution - 0084
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • Active, not recruiting
      • Local Institution - 0082
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Completed
      • Local Institution - 0204
    • Beijing, Beijing Municipality, China, 101149
      • Active, not recruiting
      • Local Institution - 0336
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Active, not recruiting
      • Local Institution - 0203
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Active, not recruiting
      • Local Institution - 0308
    • Xiamen, Fujian, China, 361003
      • Completed
      • Local Institution - 0212
  • Guangdong
    • Shantou, Guangdong, China, 515000
      • Active, not recruiting
      • Local Institution - 0234
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Active, not recruiting
      • Local Institution - 0227
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Active, not recruiting
      • Local Institution - 0209
    • Wuhan, Hubei, China, 430100
      • Active, not recruiting
      • Local Institution - 0208
  • Hunan
    • Changsha, Hunan, China, 410013
      • Active, not recruiting
      • Local Institution - 0216
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Active, not recruiting
      • Local Institution - 0233
  • Jilin
    • Changchun, Jilin, China, 132000
      • Active, not recruiting
      • Local Institution - 0244
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Not yet recruiting
      • Local Institution - 0235
      • Contact: Site 0235
  • Shaanxi
    • Xi'an, Shaanxi, China, 710126
      • Completed
      • Local Institution - 0335
  • Shandong
    • Jinan, Shandong, China, 250117
      • Active, not recruiting
      • Local Institution - 0200
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Active, not recruiting
      • Local Institution - 0206
    • Shanghai, Shanghai Municipality, China, 200032
      • Active, not recruiting
      • Local Institution - 0210
    • Shanghai, Shanghai Municipality, China, 200120
      • Active, not recruiting
      • Local Institution - 0186
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Active, not recruiting
      • Local Institution - 0330
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Active, not recruiting
      • Local Institution - 0213
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Active, not recruiting
      • Local Institution - 0236
    • Hangzhou, Zhejiang, China, 310022
      • Active, not recruiting
      • Local Institution - 0237
    • Linhai, Zhejiang, China, 317000
      • Active, not recruiting
      • Local Institution - 0229
• Czechia
  • Olomouc, Czechia, 779 00
    • Active, not recruiting
    • Local Institution - 0116
  • Brno-město
    • Brno, Brno-město, Czechia, 656 53
      • Active, not recruiting
      • Local Institution - 0114
  • Ostrava Město
    • Ostrava, Ostrava Město, Czechia, 703 00
      • Active, not recruiting
      • Local Institution - 0117
  • Praha 4
    • Prague, Praha 4, Czechia, 14059
      • Active, not recruiting
      • Local Institution - 0113
• France
  • Marseille, France, 13915
    • Active, not recruiting
    • Local Institution - 0043
  • Paris, France, 75248
    • Active, not recruiting
    • Local Institution - 0050
  • Quimper, France, 29000
    • Active, not recruiting
    • Local Institution - 0215
  • Hérault
    • Montpellier, Hérault, France, 34090
      • Active, not recruiting
      • Local Institution - 0048
  • Isère
    • La Tronche, Isère, France, 38700
      • Active, not recruiting
      • Local Institution - 0040
  • Nord
    • Lille, Nord, France, 59037
      • Completed
      • Local Institution - 0052
  • Rhône
    • Gleizé, Rhône, France, 69400
      • Completed
      • Local Institution - 0044
    • Pierre-Bénite, Rhône, France, 69310
      • Active, not recruiting
      • Local Institution - 0051
  • Val-de-Marne
    • Créteil, Val-de-Marne, France, 94010
      • Completed
      • Local Institution - 0047
    • Villejuif, Val-de-Marne, France, 94800
      • Active, not recruiting
      • Local Institution - 0038
• Germany
  • Gauting, Germany, 82131
    • Active, not recruiting
    • Local Institution - 0258
  • Großhansdorf, Germany, 22927
    • Active, not recruiting
    • Local Institution - 0259
  • Heidelberg, Germany, 69126
    • Recruiting
    • Thoraxklinik-Heidelberg gGmbH
    • Contact: Michael Thomas, Site 0260; Phone Number: 0049-173-6762839
  • Stuttgart, Germany, 70736
    • Active, not recruiting
    • Local Institution - 0264
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60488
      • Active, not recruiting
      • Local Institution - 0256
  • Lower Saxony
    • Oldenburg, Lower Saxony, Germany, 26121
      • Active, not recruiting
      • Local Institution - 0262
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 51109
      • Active, not recruiting
      • Local Institution - 0261
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06120
      • Active, not recruiting
      • Local Institution - 0265
  • Thuringia
    • Bad Berka, Thuringia, Germany, 99437
      • Active, not recruiting
      • Local Institution - 0257
• Greece
  • Attikí
    • Athens, Attikí, Greece, 115 26
      • Active, not recruiting
      • Local Institution - 0063
    • Athens, Attikí, Greece, 115 27
      • Active, not recruiting
      • Local Institution - 0064
  • Kentrikí Makedonía
    • Thessaloniki, Kentrikí Makedonía, Greece, 540 07
      • Completed
      • Local Institution - 0062
  • Thessaloníki
    • Thessaloniki, Thessaloníki, Greece, 570 01
      • Active, not recruiting
      • Local Institution - 0058
  • Thessalía
    • Larissa, Thessalía, Greece, 41110
      • Active, not recruiting
      • Local Institution - 0059
• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560017
      • Active, not recruiting
      • Local Institution - 0274
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110029
      • Withdrawn
      • Local Institution - 0278
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625107
      • Active, not recruiting
      • Local Institution - 0271
  • Uttar Pradesh
    • Varanasi, Uttar Pradesh, India, 221005
      • Active, not recruiting
      • Local Institution - 0277
  • West Bengal
    • Kolkata, West Bengal, India, 700094
      • Active, not recruiting
      • Local Institution - 0273
• Italy
  • Bologna, Italy, 40138
    • Active, not recruiting
    • Local Institution - 0074
  • Milan, Italy, 20141
    • Active, not recruiting
    • Local Institution - 0067
  • Campania
    • Naples, Campania, Italy, 80131
      • Active, not recruiting
      • Local Institution - 0072
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Active, not recruiting
      • Local Institution - 0068
  • Roma
    • Rome, Roma, Italy, 00144
      • Active, not recruiting
      • Local Institution - 0069
  • Umbria
    • Perugia, Umbria, Italy, 06132
      • Active, not recruiting
      • Local Institution - 0110
  • Verona
    • Peschiera del Garda, Verona, Italy, 37019
      • Active, not recruiting
      • Local Institution - 0070
• Japan
  • Fukushima, Japan, 960-1295
    • Active, not recruiting
    • Local Institution - 0327
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Active, not recruiting
      • Local Institution - 0319
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Active, not recruiting
      • Local Institution - 0292
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0608648
      • Active, not recruiting
      • Local Institution - 0313
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0047
      • Active, not recruiting
      • Local Institution - 0323
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Active, not recruiting
      • Local Institution - 0321
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0051
      • Completed
      • Local Institution - 0316
  • Miyagi
    • Sendai, Miyagi, Japan, 9810914
      • Active, not recruiting
      • Local Institution - 0291
  • Nara
    • Kashihara, Nara, Japan, 634-8522
      • Completed
      • Local Institution - 0324
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 710-8602
      • Active, not recruiting
      • Local Institution - 0328
  • Osaka
    • Hirakata, Osaka, Japan, 573-1191
      • Active, not recruiting
      • Local Institution - 0317
    • Takatsuki, Osaka, Japan, 569-8686
      • Completed
      • Local Institution - 0325
    • Ōsaka-sayama, Osaka, Japan, 589-8511
      • Active, not recruiting
      • Local Institution - 0314
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Active, not recruiting
      • Local Institution - 0320
    • Ina-machi, Saitama, Japan, 362-0806
      • Active, not recruiting
      • Local Institution - 0318
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Active, not recruiting
      • Local Institution - 0322
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 1138603
      • Active, not recruiting
      • Local Institution - 0326
    • Koto, Tokyo, Japan, 135-8550
      • Active, not recruiting
      • Local Institution - 0315
• Malaysia
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
      • Recruiting
      • Hospital Kuala Lumpur
      • Contact: Prathepamalar Yehgambaram, Site 0310; Phone Number: 60124415755
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
      • Completed
      • Local Institution - 0312
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Active, not recruiting
      • Local Institution - 0311
• Mexico
  • Puebla City, Mexico, 72424
    • Active, not recruiting
    • Local Institution - 0145
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44630
      • Active, not recruiting
      • Local Institution - 0146
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Active, not recruiting
    • Local Institution - 0099
  • Groningen, Netherlands, 9713 GZ
    • Active, not recruiting
    • Local Institution - 0098
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1081 HV
      • Completed
      • Local Institution - 0097
• Poland
  • Bydgoszcz, Poland, 85796
    • Active, not recruiting
    • Local Institution - 0195
  • Greater Poland Voivodeship
    • Konin, Greater Poland Voivodeship, Poland, 62-500
      • Recruiting
      • Przychodnia Lekarska KOMED
      • Contact: Boguslawa Karaszewska, Site 0193; Phone Number: 48632428009
    • Poznan, Greater Poland Voivodeship, Poland, 60-192
      • Active, not recruiting
      • Local Institution - 0241
  • Pomeranian Voivodeship
    • Prabuty, Pomeranian Voivodeship, Poland, 82-550
      • Active, not recruiting
      • Local Institution - 0192
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 93-338
      • Active, not recruiting
      • Local Institution - 0189
• Romania
  • Cluj-Napoca, Romania, 400015
    • Active, not recruiting
    • Local Institution - 0141
  • Iași, Romania, 700106
    • Recruiting
    • S.C. Centrul de Oncologie Euroclinic S.R.L.
    • Contact: Constantin Volovat, Site 0139; Phone Number: 40746110096
  • Iași, Romania, 700483
    • Recruiting
    • Institutul Regional de Oncologie
    • Contact: Dana Clement, Site 0132; Phone Number: 40744692062
  • Bucharest
    • Bucharest, Bucharest, Romania, 013812
      • Active, not recruiting
      • Local Institution - 0133
    • Bucharest, Bucharest, Romania, 022328
      • Active, not recruiting
      • Local Institution - 0135
  • Cluj
    • Florești, Cluj, Romania, 407280
      • Active, not recruiting
      • Local Institution - 0137
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Active, not recruiting
      • Local Institution - 0140
• South Korea
  • Chungcheongbuk-do [Chungbuk]
    • Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea, 28644
      • Active, not recruiting
      • Local Institution - 0305
  • Kyǒnggi-do
    • Seongnam, Kyǒnggi-do, South Korea, 13620
      • Active, not recruiting
      • Local Institution - 0286
    • Suwon, Kyǒnggi-do, South Korea, 16499
      • Active, not recruiting
      • Local Institution - 0304
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
      • Active, not recruiting
      • Local Institution - 0285
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
      • Active, not recruiting
      • Local Institution - 0293
  • Taegu-Kwangyǒkshi
    • Daegu, Taegu-Kwangyǒkshi, South Korea, 42601
      • Active, not recruiting
      • Local Institution - 0309
• Spain
  • Seville, Spain, 41009
    • Active, not recruiting
    • Local Institution - 0299
  • Seville, Spain, 41013
    • Active, not recruiting
    • Local Institution - 0295
  • A Coruña [La Coruña]
    • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
      • Active, not recruiting
      • Local Institution - 0300
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 08036
      • Completed
      • Local Institution - 0294
    • Barcelona, Catalunya [Cataluña], Spain, 08041
      • Active, not recruiting
      • Local Institution - 0302
  • Jaén
    • Jaén, Jaén, Spain, 23007
      • Active, not recruiting
      • Local Institution - 0301
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Active, not recruiting
      • Local Institution - 0298
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Active, not recruiting
      • Local Institution - 0296
    • Majadahonda, Madrid, Comunidad de, Spain, 28222
      • Active, not recruiting
      • Local Institution - 0297
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46014
      • Active, not recruiting
      • Local Institution - 0303
• Switzerland
  • Chur, Switzerland, 7000
    • Active, not recruiting
    • Local Institution - 0248
  • Winterthur, Switzerland, 8401
    • Active, not recruiting
    • Local Institution - 0249
  • Zurich, Switzerland, 8091
    • Active, not recruiting
    • Local Institution - 0247
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01370
    • Active, not recruiting
    • Local Institution - 0154
  • Ankara, Turkey (Türkiye), 06010
    • Active, not recruiting
    • Local Institution - 0157
  • Ankara, Turkey (Türkiye), 06280
    • Active, not recruiting
    • Local Institution - 0177
  • Istanbul, Turkey (Türkiye), 34732
    • Active, not recruiting
    • Local Institution - 0153
  • İzmir
    • Çiğli, İzmir, Turkey (Türkiye), 35620
      • Active, not recruiting
      • Local Institution - 0158
• United Kingdom
  • Aberdeen, United Kingdom, AB9 2ZB
    • Completed
    • Local Institution - 0159
  • Manchester, United Kingdom, M20 4BX
    • Active, not recruiting
    • Local Institution - 0101
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • Active, not recruiting
    • Local Institution - 0226
  • Middlesbrough
    • Central Middlesbrough, Middlesbrough, United Kingdom, TS4 3BW
      • Completed
      • Local Institution - 0183
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Recruiting
      • Southern Cancer Center, PC
      • Contact: Michael Meshad, Site 0337; Phone Number: 111-111-1111
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Completed
      • Local Institution - 0283
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Recruiting
      • Florida Cancer Specialists - South
      • Contact: Alexander Glick, Site 0245; Phone Number: 239-274-9930
    • Orange City, Florida, United States, 32763
      • Recruiting
      • Mid Florida Hematology and Oncology Center
      • Contact: Santosh Nair, Site 0009; Phone Number: 407-353-1915
    • St. Petersburg, Florida, United States, 33705
      • Recruiting
      • Florida Cancer Specialists - North
      • Contact: Maen Hussein, Site 0020; Phone Number: 727-216-1143
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Recruiting
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
      • Contact: Walid Shaib, Site 0013; Phone Number: 770-281-5124
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Recruiting
      • Illinois Cancer Care
      • Contact: Gary MacVicar, Site 0019; Phone Number: 309-243-3000
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Withdrawn
      • Local Institution - 0037
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Recruiting
      • University of New Mexico Comprehensive Cancer Center
      • Contact: Moises Harari-Turquie, Site 0033; Phone Number: 505-570-5835
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Cancer Institute
      • Contact: Neal Ready, Site 0029; Phone Number: 919-684-8239
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Recruiting
      • Sanford Medical Center
      • Contact: Thandiwe Gray, Site 0232; Phone Number: 701-323-5741
    • Fargo, North Dakota, United States, 58102
      • Recruiting
      • Sanford Fargo Medical Center
      • Contact: Mark Gitau, Site 0010; Phone Number: 000-000-0000
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Oncology Hematology Care
      • Contact: Patrick Ward, Site 0284; Phone Number: 513-751-2273
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Recruiting
      • Sanford Cancer Center
      • Contact: Allison Watson, Site 0231; Phone Number: 605-209-4092
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners
      • Contact: Melissa Johnson, Site 0008; Phone Number: 615-329-7274
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Oncology - Central/South Texas
      • Contact: James Uyeki, Site 0001; Phone Number: 512-427-9400
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology - Northeast Texas
      • Contact: Sarah Wang, Site 0281; Phone Number: 903-579-9800
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Oncology & Hematology Associates of Southwest Virginia, Inc.
      • Contact: Jerome Goldschmidt, Site 0246; Phone Number: 540-381-5291
  • Washington
    • Edmonds, Washington, United States, 98026
      • Recruiting
      • Swedish Cancer Institute - Edmonds
      • Contact: Siddhartha Devarakonda, Site 0339; Phone Number: 206-386-2457
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Swedish Medical Center
      • Contact: Siddhartha Devarakonda, Site 0026; Phone Number: 206-386-2457

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A	Drug: Carboplatin; Specified dose on specified days; Drug: Etoposide; Specified dose on specified days; Biological: BMS-986489 (BMS-986012+Nivolumab); Specified dose on specified days
Active Comparator: Arm B	Drug: Carboplatin; Specified dose on specified days; Drug: Etoposide; Specified dose on specified days; Biological: Atezolizumab; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival (PFS)	Up to 5 years
Duration of Response (DOR)	Up to 5 years
Objective Response (OR)	Up to 5 years
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): April 6, 2028
• Study Completion (Estimated): September 5, 2031

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nivolumab; Carboplatin; Etoposide; ES-SCLC; SCLC; BMS-986012; Extensive-Stage Small Cell Lung Cancer; BMS-986489; TIGOS; fucGM1; atigotatug
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Coordination Complexes; Etoposide; Carboplatin; atezolizumab
• Other Study ID Numbers: CA245-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No