RecruitingPhase 3NCT06646276

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).


Sponsor

Bristol-Myers Squibb

Enrollment

530 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (TIGOS) is comparing two immunotherapy-based chemotherapy combinations as initial treatment for extensive-stage small cell lung cancer (ES-SCLC) — a fast-growing form of lung cancer that has spread beyond the chest. One combination uses a new drug (BMS-986489 containing nivolumab + BMS-986012) alongside chemotherapy; the other uses atezolizumab plus chemotherapy. **You may be eligible if...** - You have been diagnosed with extensive-stage small cell lung cancer - You have not yet received treatment for this diagnosis - You are healthy enough to carry out most daily activities with little or no help - You have at least one tumor measurable on imaging outside the brain **You may NOT be eligible if...** - You have already received treatment for extensive-stage small cell lung cancer - Your cancer has spread to the brain and is causing symptoms - You have significant lung disease, heart disease, active infections, autoimmune disease, other active cancers, or nerve damage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBMS-986489 (BMS-986012+Nivolumab)

Specified dose on specified days

BIOLOGICALAtezolizumab

Specified dose on specified days

DRUGCarboplatin

Specified dose on specified days

DRUGEtoposide

Specified dose on specified days


Locations(183)

Southern Cancer Center, PC

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

St. 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

Duke Cancer Institute

Durham, North Carolina, United States

Sanford Medical Center

Bismarck, North Dakota, United States

Sanford Fargo Medical Center

Fargo, North Dakota, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Sanford Cancer Center

Sioux Falls, South Dakota, 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 Cancer Institute - Edmonds

Edmonds, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

Local Institution - 0079

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0077

ABB, Buenos Aires F.D., Argentina

Local Institution - 0100

Buenos Aires, Buenos Aires F.D., Argentina

Local Institution - 0080

CABA, Buenos Aires F.D., Argentina

Local Institution - 0094

Río Cuarto, Córdoba Province, 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 - 0253

Graz, Styria, Austria

Local Institution - 0251

Wels, Upper Austria, Austria

Local Institution - 0252

Linz, Austria

Local Institution - 0255

Rankweil, Austria

Local Institution - 0198

Brussels, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0091

Ghent, Oost-Vlaanderen, Belgium

Local Institution - 0187

Sint-Niklaas, Oost-Vlaanderen, 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

São Paulo, São Paulo, Brazil

Local Institution - 0289

Edmonton, Alberta, Canada

Local Institution - 0290

Chicoutimi, Quebec, Canada

Local Institution - 0288

Québec, Quebec, Canada

Local Institution - 0287

Rimouski, Quebec, Canada

Local Institution - 0086

Santiago, Santiago Metropolitan, Chile

Local Institution - 0085

Santiago, Santiago Metropolitan, Chile

Local Institution - 0083

Santiago, Santiago Metropolitan, Chile

Local Institution - 0084

Santiago, Santiago Metropolitan, Chile

Local Institution - 0082

Viña del Mar, Valparaiso, Chile

Local Institution - 0204

Beijing, Beijing Municipality, China

Local Institution - 0336

Beijing, Beijing Municipality, China

Local Institution - 0203

Chongqing, Chongqing Municipality, China

Local Institution - 0308

Fuzhou, Fujian, China

Local Institution - 0212

Xiamen, Fujian, China

Local Institution - 0234

Shantou, Guangdong, China

Local Institution - 0227

Harbin, Heilongjiang, China

Local Institution - 0209

Wuhan, Hubei, China

Local Institution - 0208

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

Local Institution - 0200

Jinan, Shandong, China

Local Institution - 0206

Shanghai, Shanghai Municipality, China

Local Institution - 0210

Shanghai, Shanghai Municipality, China

Local Institution - 0186

Shanghai, Shanghai Municipality, China

Local Institution - 0330

Chengdu, Sichuan, China

Local Institution - 0213

Tianjin, Tianjin Municipality, China

Local Institution - 0236

Hangzhou, Zhejiang, China

Local Institution - 0237

Hangzhou, Zhejiang, China

Local Institution - 0229

Linhai, Zhejiang, 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, France

Local Institution - 0044

Gleizé, 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 am Main, Hesse, Germany

Local Institution - 0262

Oldenburg, Lower Saxony, Germany

Local Institution - 0261

Cologne, North Rhine-Westphalia, Germany

Local Institution - 0265

Halle, Saxony-Anhalt, Germany

Local Institution - 0257

Bad Berka, Thuringia, Germany

Local Institution - 0258

Gauting, Germany

Local Institution - 0259

Großhansdorf, Germany

Thoraxklinik-Heidelberg gGmbH

Heidelberg, 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 - 0274

Bengaluru, Karnataka, India

Local Institution - 0278

New Delhi, National Capital Territory of Delhi, 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

Naples, Campania, Italy

Local Institution - 0068

Milan, Lombardy, 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

Milan, Italy

Local Institution - 0319

Matsuyama, Ehime, Japan

Local Institution - 0292

Kurume, Fukuoka, Japan

Local Institution - 0313

Sapporo, Hokkaido, Japan

Local Institution - 0323

Kobe, Hyōgo, Japan

Local Institution - 0321

Kanazawa, Ishikawa-ken, Japan

Local Institution - 0316

Yokohama, Kanagawa, Japan

Local Institution - 0291

Sendai, Miyagi, Japan

Local Institution - 0324

Kashihara, Nara, Japan

Local Institution - 0328

Kurashiki, Okayama-ken, Japan

Local Institution - 0317

Hirakata, Osaka, Japan

Local Institution - 0314

Ōsaka-sayama, 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

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, Malaysia

Local Institution - 0312

Kuala Lumpur, Kuala Lumpur, Malaysia

Local Institution - 0311

Kuching, Sarawak, Malaysia

Local Institution - 0146

Guadalajara, Jalisco, Mexico

Local Institution - 0145

Puebla City, Mexico

Local Institution - 0097

Amsterdam, North Holland, Netherlands

Local Institution - 0099

Arnhem, Netherlands

Local Institution - 0098

Groningen, Netherlands

Local Institution - 0193

Konin, Greater Poland Voivodeship, Poland

Local Institution - 0241

Poznan, Greater Poland Voivodeship, Poland

Local Institution - 0192

Prabuty, Pomeranian Voivodeship, Poland

Local Institution - 0195

Bydgoszcz, Poland

Local Institution - 0189

Lodz, Łódź Voivodeship, Poland

Local Institution - 0133

Bucharest, Bucharest, Romania

Local Institution - 0135

Bucharest, Bucharest, Romania

Local Institution - 0137

Florești, Cluj, Romania

Local Institution - 0140

Craiova, Dolj, Romania

Local Institution - 0141

Cluj-Napoca, Romania

S.C. Centrul de Oncologie Euroclinic S.R.L.

Iași, Romania

Institutul Regional de Oncologie

Iași, Romania

Local Institution - 0305

Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea

Local Institution - 0286

Seongnam, Kyǒnggi-do, South Korea

Local Institution - 0304

Suwon, Kyǒnggi-do, South Korea

Local Institution - 0285

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0293

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0309

Daegu, Taegu-Kwangyǒkshi, South Korea

Local Institution - 0300

Santiago de Compostela, A Coruña [La Coruña], Spain

Local Institution - 0294

Barcelona, Catalunya [Cataluña], Spain

Local Institution - 0302

Barcelona, Catalunya [Cataluña], Spain

Local Institution - 0301

Jaén, Jaén, Spain

Local Institution - 0298

Madrid, Madrid, Comunidad de, Spain

Local Institution - 0296

Madrid, Madrid, Comunidad de, Spain

Local Institution - 0297

Majadahonda, Madrid, Comunidad de, Spain

Local Institution - 0303

Valencia, Valenciana, Comunitat, Spain

Local Institution - 0299

Seville, Spain

Local Institution - 0295

Seville, Spain

Local Institution - 0248

Chur, Switzerland

Local Institution - 0249

Winterthur, Switzerland

Local Institution - 0247

Zurich, Switzerland

Local Institution - 0158

Çiğli, İzmir, Turkey (Türkiye)

Local Institution - 0154

Adana, Turkey (Türkiye)

Local Institution - 0157

Ankara, Turkey (Türkiye)

Local Institution - 0177

Ankara, Turkey (Türkiye)

Local Institution - 0153

Istanbul, Turkey (Türkiye)

Local Institution - 0183

Central Middlesbrough, Middlesbrough, United Kingdom

Local Institution - 0159

Aberdeen, United Kingdom

Local Institution - 0101

Manchester, United Kingdom

Local Institution - 0226

Metropolitan Borough of Wirral, United Kingdom

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NCT06646276


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