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 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CA245-0001
• Study Type: interventional
• Target: 530
• Locations: 25 countries
• Sites: 179

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.

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; atigotatug

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Up to 5 years

Secondary Outcomes (7)

• 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

Study Arms (2)

Arm A

EXPERIMENTAL

Biological: BMS-986489 (BMS-986012+Nivolumab); Drug: Carboplatin; Drug: Etoposide

Arm B

ACTIVE COMPARATOR

Biological: Atezolizumab; Drug: Carboplatin; Drug: Etoposide

Interventions

Atezolizumab BIOLOGICAL

Specified dose on specified days

Arm B

Carboplatin DRUG

Specified dose on specified days

Arm A; Arm B

Etoposide DRUG

Specified dose on specified days

Arm A; Arm B

BMS-986489 (BMS-986012+Nivolumab) BIOLOGICAL

Specified dose on specified days

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (183)

Southern Cancer Center, PC

Daphne, Alabama, 36526, United States

RECRUITING

Local Institution - 0283

Hot Springs, Arkansas, 71913, United States

COMPLETED

Florida Cancer Specialists - South

Fort Myers, Florida, 33901, United States

RECRUITING

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

RECRUITING

Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States

RECRUITING

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, 30060, United States

RECRUITING

Illinois Cancer Care

Peoria, Illinois, 61615, United States

RECRUITING

Local Institution - 0037

Minneapolis, Minnesota, 55407, United States

WITHDRAWN

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Sanford Medical Center

Bismarck, North Dakota, 58501, United States

RECRUITING

Sanford Fargo Medical Center

Fargo, North Dakota, 58102, United States

RECRUITING

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

RECRUITING

Sanford Cancer Center

Sioux Falls, South Dakota, 57104, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Central/South Texas

Austin, Texas, 78705, United States

RECRUITING

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

RECRUITING

Swedish Cancer Institute - Edmonds

Edmonds, Washington, 98026, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Local Institution - 0079

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

COMPLETED

Local Institution - 0077

ABB, Buenos Aires F.D., C1199ABB, Argentina

COMPLETED

Local Institution - 0100

Buenos Aires, Buenos Aires F.D., C1417DTB, Argentina

WITHDRAWN

Local Institution - 0080

CABA, Buenos Aires F.D., C1430EGF, Argentina

ACTIVE NOT RECRUITING

Local Institution - 0094

Río Cuarto, Córdoba Province, X5800AEV, Argentina

ACTIVE NOT RECRUITING

Local Institution - 0202

Campbelltown, New South Wales, 2560, Australia

ACTIVE NOT RECRUITING

Local Institution - 0106

Penrith, New South Wales, 2750, Australia

ACTIVE NOT RECRUITING

Local Institution - 0105

Brisbane, Queensland, 4120, Australia

ACTIVE NOT RECRUITING

Local Institution - 0190

Ballarat Central, Victoria, 3350, Australia

COMPLETED

Local Institution - 0175

Murdoch, Western Australia, 6150, Australia

ACTIVE NOT RECRUITING

Local Institution - 0253

Graz, Styria, 8036, Austria

ACTIVE NOT RECRUITING

Local Institution - 0251

Wels, Upper Austria, 4600, Austria

ACTIVE NOT RECRUITING

Local Institution - 0252

Linz, 4021, Austria

ACTIVE NOT RECRUITING

Local Institution - 0255

Rankweil, 6830, Austria

ACTIVE NOT RECRUITING

Local Institution - 0198

Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

ACTIVE NOT RECRUITING

Local Institution - 0091

Ghent, Oost-Vlaanderen, 9000, Belgium

ACTIVE NOT RECRUITING

Local Institution - 0187

Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium

ACTIVE NOT RECRUITING

Local Institution - 0092

Liège, 4000, Belgium

ACTIVE NOT RECRUITING

Local Institution - 0166

Fortaleza, Ceará, 60135-237, Brazil

ACTIVE NOT RECRUITING

Local Institution - 0165

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

ACTIVE NOT RECRUITING

Local Institution - 0169

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

ACTIVE NOT RECRUITING

Local Institution - 0170

Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil

COMPLETED

Local Institution - 0163

Itajaí, Santa Catarina, 88301-220, Brazil

ACTIVE NOT RECRUITING

Local Institution - 0178

Barretos, São Paulo, 14784400, Brazil

ACTIVE NOT RECRUITING

Local Institution - 0111

São Paulo, São Paulo, 01509-010, Brazil

ACTIVE NOT RECRUITING

Local Institution - 0289

Edmonton, Alberta, T6G 1Z2, Canada

ACTIVE NOT RECRUITING

Local Institution - 0290

Chicoutimi, Quebec, G7H 5H6, Canada

ACTIVE NOT RECRUITING

Local Institution - 0288

Québec, Quebec, G1V 4G5, Canada

ACTIVE NOT RECRUITING

Local Institution - 0287

Rimouski, Quebec, G5L 5T1, Canada

ACTIVE NOT RECRUITING

Local Institution - 0086

Santiago, Santiago Metropolitan, 0, Chile

ACTIVE NOT RECRUITING

Local Institution - 0085

Santiago, Santiago Metropolitan, 7500921, Chile

ACTIVE NOT RECRUITING

Local Institution - 0083

Santiago, Santiago Metropolitan, 8330032, Chile

COMPLETED

Local Institution - 0084

Santiago, Santiago Metropolitan, 8420383, Chile

ACTIVE NOT RECRUITING

Local Institution - 0082

Viña del Mar, Valparaiso, 2520598, Chile

ACTIVE NOT RECRUITING

Local Institution - 0204

Beijing, Beijing Municipality, 100142, China

COMPLETED

Local Institution - 0336

Beijing, Beijing Municipality, 101149, China

ACTIVE NOT RECRUITING

Local Institution - 0203

Chongqing, Chongqing Municipality, 400030, China

ACTIVE NOT RECRUITING

Local Institution - 0308

Fuzhou, Fujian, 350014, China

ACTIVE NOT RECRUITING

Local Institution - 0212

Xiamen, Fujian, 361003, China

COMPLETED

Local Institution - 0234

Shantou, Guangdong, 515000, China

ACTIVE NOT RECRUITING

Local Institution - 0227

Harbin, Heilongjiang, 150081, China

ACTIVE NOT RECRUITING

Local Institution - 0209

Wuhan, Hubei, 430079, China

ACTIVE NOT RECRUITING

Local Institution - 0208

Wuhan, Hubei, 430100, China

ACTIVE NOT RECRUITING

Local Institution - 0216

Changsha, Hunan, 410013, China

ACTIVE NOT RECRUITING

Local Institution - 0233

Nanchang, Jiangxi, 330006, China

ACTIVE NOT RECRUITING

Local Institution - 0244

Changchun, Jilin, 132000, China

ACTIVE NOT RECRUITING

Local Institution - 0235

Shenyang, Liaoning, 110042, China

NOT YET RECRUITING

Local Institution - 0335

Xi'an, Shaanxi, 710126, China

COMPLETED

Local Institution - 0200

Jinan, Shandong, 250117, China

ACTIVE NOT RECRUITING

Local Institution - 0206

Shanghai, Shanghai Municipality, 200030, China

ACTIVE NOT RECRUITING

Local Institution - 0210

Shanghai, Shanghai Municipality, 200032, China

ACTIVE NOT RECRUITING

Local Institution - 0186

Shanghai, Shanghai Municipality, 200120, China

ACTIVE NOT RECRUITING

Local Institution - 0330

Chengdu, Sichuan, 610041, China

ACTIVE NOT RECRUITING

Local Institution - 0213

Tianjin, Tianjin Municipality, 300060, China

ACTIVE NOT RECRUITING

Local Institution - 0236

Hangzhou, Zhejiang, 310016, China

ACTIVE NOT RECRUITING

Local Institution - 0237

Hangzhou, Zhejiang, 310022, China

ACTIVE NOT RECRUITING

Local Institution - 0229

Linhai, Zhejiang, 317000, China

ACTIVE NOT RECRUITING

Local Institution - 0114

Brno, Brno-město, 656 53, Czechia

ACTIVE NOT RECRUITING

Local Institution - 0117

Ostrava, Ostrava Město, 703 00, Czechia

ACTIVE NOT RECRUITING

Local Institution - 0113

Prague, Praha 4, 14059, Czechia

ACTIVE NOT RECRUITING

Local Institution - 0116

Olomouc, 779 00, Czechia

ACTIVE NOT RECRUITING

Local Institution - 0048

Montpellier, Hérault, 34090, France

COMPLETED

Local Institution - 0040

La Tronche, Isère, 38700, France

ACTIVE NOT RECRUITING

Local Institution - 0052

Lille, Nord, 59037, France

COMPLETED

Local Institution - 0044

Gleizé, Rhône, 69400, France

COMPLETED

Local Institution - 0051

Pierre-Bénite, Rhône, 69310, France

ACTIVE NOT RECRUITING

Local Institution - 0047

Créteil, Val-de-Marne, 94010, France

COMPLETED

Local Institution - 0038

Villejuif, Val-de-Marne, 94800, France

ACTIVE NOT RECRUITING

Local Institution - 0043

Marseille, 13915, France

ACTIVE NOT RECRUITING

Local Institution - 0050

Paris, 75248, France

ACTIVE NOT RECRUITING

Local Institution - 0215

Quimper, 29000, France

ACTIVE NOT RECRUITING

Local Institution - 0256

Frankfurt am Main, Hesse, 60488, Germany

ACTIVE NOT RECRUITING

Local Institution - 0262

Oldenburg, Lower Saxony, 26121, Germany

ACTIVE NOT RECRUITING

Local Institution - 0261

Cologne, North Rhine-Westphalia, 51109, Germany

ACTIVE NOT RECRUITING

Local Institution - 0265

Halle, Saxony-Anhalt, 06120, Germany

ACTIVE NOT RECRUITING

Local Institution - 0257

Bad Berka, Thuringia, 99437, Germany

ACTIVE NOT RECRUITING

Local Institution - 0258

Gauting, 82131, Germany

COMPLETED

Local Institution - 0259

Großhansdorf, 22927, Germany

ACTIVE NOT RECRUITING

Thoraxklinik-Heidelberg gGmbH

Heidelberg, 69126, Germany

RECRUITING

Local Institution - 0264

Stuttgart, 70736, Germany

ACTIVE NOT RECRUITING

Local Institution - 0063

Athens, Attikí, 115 26, Greece

ACTIVE NOT RECRUITING

Local Institution - 0064

Athens, Attikí, 115 27, Greece

ACTIVE NOT RECRUITING

Local Institution - 0062

Thessaloniki, Kentrikí Makedonía, 540 07, Greece

COMPLETED

Local Institution - 0058

Thessaloniki, Thessaloníki, 570 01, Greece

ACTIVE NOT RECRUITING

Local Institution - 0059

Larissa, Thessalía, 41110, Greece

COMPLETED

Local Institution - 0274

Bengaluru, Karnataka, 560017, India

ACTIVE NOT RECRUITING

Local Institution - 0278

New Delhi, National Capital Territory of Delhi, 110029, India

WITHDRAWN

Local Institution - 0271

Madurai, Tamil Nadu, 625107, India

ACTIVE NOT RECRUITING

Local Institution - 0277

Varanasi, Uttar Pradesh, 221005, India

ACTIVE NOT RECRUITING

Local Institution - 0273

Kolkata, West Bengal, 700094, India

ACTIVE NOT RECRUITING

Local Institution - 0072

Naples, Campania, 80131, Italy

ACTIVE NOT RECRUITING

Local Institution - 0068

Milan, Lombardy, 20133, Italy

ACTIVE NOT RECRUITING

Local Institution - 0069

Rome, Roma, 00144, Italy

ACTIVE NOT RECRUITING

Local Institution - 0110

Perugia, Umbria, 06132, Italy

ACTIVE NOT RECRUITING

Local Institution - 0070

Peschiera del Garda, Verona, 37019, Italy

ACTIVE NOT RECRUITING

Local Institution - 0074

Bologna, 40138, Italy

ACTIVE NOT RECRUITING

Local Institution - 0067

Milan, 20141, Italy

ACTIVE NOT RECRUITING

Local Institution - 0319

Matsuyama, Ehime, 791-0280, Japan

ACTIVE NOT RECRUITING

Local Institution - 0292

Kurume, Fukuoka, 830-0011, Japan

ACTIVE NOT RECRUITING

Local Institution - 0313

Sapporo, Hokkaido, 0608648, Japan

ACTIVE NOT RECRUITING

Local Institution - 0323

Kobe, Hyōgo, 650-0047, Japan

ACTIVE NOT RECRUITING

Local Institution - 0321

Kanazawa, Ishikawa-ken, 920-8641, Japan

ACTIVE NOT RECRUITING

Local Institution - 0316

Yokohama, Kanagawa, 236-0051, Japan

COMPLETED

Local Institution - 0291

Sendai, Miyagi, 9810914, Japan

ACTIVE NOT RECRUITING

Local Institution - 0324

Kashihara, Nara, 634-8522, Japan

COMPLETED

Local Institution - 0328

Kurashiki, Okayama-ken, 710-8602, Japan

ACTIVE NOT RECRUITING

Local Institution - 0317

Hirakata, Osaka, 573-1191, Japan

ACTIVE NOT RECRUITING

Local Institution - 0314

Ōsaka-sayama, Osaka, 589-8511, Japan

ACTIVE NOT RECRUITING

Local Institution - 0325

Takatsuki, Osaka, 569-8686, Japan

COMPLETED

Local Institution - 0320

Hidaka, Saitama, 350-1298, Japan

ACTIVE NOT RECRUITING

Local Institution - 0318

Ina-machi, Saitama, 362-0806, Japan

ACTIVE NOT RECRUITING

Local Institution - 0322

Hamamatsu, Shizuoka, 431-3192, Japan

ACTIVE NOT RECRUITING

Local Institution - 0326

Bunkyo-ku, Tokyo, 1138603, Japan

ACTIVE NOT RECRUITING

Local Institution - 0315

Koto, Tokyo, 135-8550, Japan

ACTIVE NOT RECRUITING

Local Institution - 0327

Fukushima, 960-1295, Japan

ACTIVE NOT RECRUITING

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

RECRUITING

Local Institution - 0312

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

COMPLETED

Local Institution - 0311

Kuching, Sarawak, 93586, Malaysia

ACTIVE NOT RECRUITING

Local Institution - 0146

Guadalajara, Jalisco, 44630, Mexico

ACTIVE NOT RECRUITING

Local Institution - 0145

Puebla City, 72424, Mexico

COMPLETED

Local Institution - 0097

Amsterdam, North Holland, 1081 HV, Netherlands

COMPLETED

Local Institution - 0099

Arnhem, 6815 AD, Netherlands

ACTIVE NOT RECRUITING

Local Institution - 0098

Groningen, 9713 GZ, Netherlands

ACTIVE NOT RECRUITING

Local Institution - 0193

Konin, Greater Poland Voivodeship, 62-500, Poland

ACTIVE NOT RECRUITING

Local Institution - 0241

Poznan, Greater Poland Voivodeship, 60-192, Poland

ACTIVE NOT RECRUITING

Local Institution - 0192

Prabuty, Pomeranian Voivodeship, 82-550, Poland

ACTIVE NOT RECRUITING

Local Institution - 0195

Bydgoszcz, 85796, Poland

ACTIVE NOT RECRUITING

Local Institution - 0189

Lodz, Łódź Voivodeship, 93-338, Poland

ACTIVE NOT RECRUITING

Local Institution - 0133

Bucharest, Bucharest, 013812, Romania

ACTIVE NOT RECRUITING

Local Institution - 0135

Bucharest, Bucharest, 022328, Romania

ACTIVE NOT RECRUITING

Local Institution - 0137

Florești, Cluj, 407280, Romania

ACTIVE NOT RECRUITING

Local Institution - 0140

Craiova, Dolj, 200542, Romania

ACTIVE NOT RECRUITING

Local Institution - 0141

Cluj-Napoca, 400015, Romania

ACTIVE NOT RECRUITING

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

Iași, 700106, Romania

RECRUITING

Institutul Regional de Oncologie

Iași, 700483, Romania

RECRUITING

Local Institution - 0305

Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea

ACTIVE NOT RECRUITING

Local Institution - 0286

Seongnam, Kyǒnggi-do, 13620, South Korea

ACTIVE NOT RECRUITING

Local Institution - 0304

Suwon, Kyǒnggi-do, 16499, South Korea

ACTIVE NOT RECRUITING

Local Institution - 0285

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

ACTIVE NOT RECRUITING

Local Institution - 0293

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

ACTIVE NOT RECRUITING

Local Institution - 0309

Daegu, Taegu-Kwangyǒkshi, 42601, South Korea

ACTIVE NOT RECRUITING

Local Institution - 0300

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

ACTIVE NOT RECRUITING

Local Institution - 0294

Barcelona, Catalunya [Cataluña], 08036, Spain

COMPLETED

Local Institution - 0302

Barcelona, Catalunya [Cataluña], 08041, Spain

ACTIVE NOT RECRUITING

Local Institution - 0301

Jaén, Jaén, 23007, Spain

ACTIVE NOT RECRUITING

Local Institution - 0298

Madrid, Madrid, Comunidad de, 28034, Spain

ACTIVE NOT RECRUITING

Local Institution - 0296

Madrid, Madrid, Comunidad de, 28041, Spain

ACTIVE NOT RECRUITING

Local Institution - 0297

Majadahonda, Madrid, Comunidad de, 28222, Spain

ACTIVE NOT RECRUITING

Local Institution - 0303

Valencia, Valenciana, Comunitat, 46014, Spain

COMPLETED

Local Institution - 0299

Seville, 41009, Spain

ACTIVE NOT RECRUITING

Local Institution - 0295

Seville, 41013, Spain

COMPLETED

Local Institution - 0248

Chur, 7000, Switzerland

ACTIVE NOT RECRUITING

Local Institution - 0249

Winterthur, 8401, Switzerland

ACTIVE NOT RECRUITING

Local Institution - 0247

Zurich, 8091, Switzerland

ACTIVE NOT RECRUITING

Local Institution - 0158

Çiğli, İzmir, 35620, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0154

Adana, 01370, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0157

Ankara, 06010, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0177

Ankara, 06280, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0153

Istanbul, 34732, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 0183

Central Middlesbrough, Middlesbrough, TS4 3BW, United Kingdom

COMPLETED

Local Institution - 0159

Aberdeen, AB9 2ZB, United Kingdom

COMPLETED

Local Institution - 0101

Manchester, M20 4BX, United Kingdom

ACTIVE NOT RECRUITING

Local Institution - 0226

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

ACTIVE NOT RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): April 6, 2028
• Study Completion (Estimated): September 5, 2031
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CL (5); AR (5); IN (5); FR (10); GB (4); PL (5); MY (3); AU (5); JP (18); BR (7); BE (4); CN (23); CZ (4); ME (2); US (20); KR (6); CA (4); RO (7); TU (5); DE (9); CH (3); NL (3); IT (7); ES (10); GR (5)