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 (184)

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

Local Institution - 0010

Fargo, North Dakota, 58102, United States

NOT YET 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

Instituto Alexander Fleming

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

RECRUITING

Hospital Italiano de Buenos Aires

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

RECRUITING

Local Institution - 0100

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

WITHDRAWN

Clinica Adventista Belgrano

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

RECRUITING

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, X5800AEV, Argentina

RECRUITING

GenesisCare - Campbelltown

Campbelltown, New South Wales, 2560, Australia

RECRUITING

Nepean Hospital

Penrith, New South Wales, 2750, Australia

RECRUITING

Gallipoli Medical Research Ltd

Brisbane, Queensland, 4120, Australia

RECRUITING

Grampians Health

Ballarat Central, Victoria, 3350, Australia

RECRUITING

St. John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Medizinische Universität Graz

Graz, Styria, 8036, Austria

RECRUITING

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, 4600, Austria

RECRUITING

Kepler Universitätsklinikum

Linz, 4021, Austria

RECRUITING

Landeskrankenhaus Rankweil

Rankweil, 6830, Austria

RECRUITING

Cliniques universitaires Saint-Luc

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

RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

VITAZ

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

RECRUITING

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

RECRUITING

Hospital São Carlos

Fortaleza, Ceará, 60135-237, Brazil

RECRUITING

Hospital de Clinicas de Porto Alegre

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

RECRUITING

Hospital São Lucas da PUCRS

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

RECRUITING

Instituto de Oncologia Saint Gallen

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

RECRUITING

Clínica de Neoplasias Litoral

Itajaí, Santa Catarina, 88301-220, Brazil

RECRUITING

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784400, Brazil

RECRUITING

A. C. Camargo Cancer Center

São Paulo, São Paulo, 01509-010, Brazil

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, G7H 5H6, Canada

RECRUITING

IUCPQ

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski

Rimouski, Quebec, G5L 5T1, Canada

RECRUITING

Orlandi Oncologia

Santiago, Santiago Metropolitan, 0, Chile

RECRUITING

Fundacion Arturo Lopez Perez (FALP)

Santiago, Santiago Metropolitan, 7500921, Chile

RECRUITING

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330032, Chile

RECRUITING

Bradfordhill

Santiago, Santiago Metropolitan, 8420383, Chile

RECRUITING

Oncocentro Apys

Viña del Mar, Valparaiso, 2520598, Chile

RECRUITING

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing Chest Hospital,Capital Medical University

Beijing, Beijing Municipality, 101149, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

The First Affiliated hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515000, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Wuhan Tongji Hospital

Wuhan, Hubei, 430100, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Jilin Province Tumor Hospital

Changchun, Jilin, 132000, China

RECRUITING

Local Institution - 0235

Shenyang, Liaoning, 110042, China

NOT YET RECRUITING

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710126, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Sichuan Cancer hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, 317000, China

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

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, Hérault, 34090, France

RECRUITING

Chu Grenoble Alpes

La Tronche, Isère, 38700, France

RECRUITING

CHU Lille - Institut Coeur Poumon

Lille, Nord, 59037, France

RECRUITING

L Hopital Nord Ouest

Gleizé, Rhône, 69400, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, Rhône, 69310, France

RECRUITING

Centre Hospitalier Intercommunal de Créteil

Créteil, Val-de-Marne, 94010, France

RECRUITING

Gustave Roussy

Villejuif, Val-de-Marne, 94800, France

RECRUITING

Assistance Publique Hôpitaux de Marseille - Hôpital Nord

Marseille, 13915, France

RECRUITING

Institut Curie

Paris, 75248, France

RECRUITING

Centre Hospitalier de Cornouaille Quimper - Concarneau

Quimper, 29000, France

RECRUITING

Krankenhaus Nordwest GmbH

Frankfurt am Main, Hesse, 60488, Germany

RECRUITING

Pius Hospital Oldenburg

Oldenburg, Lower Saxony, 26121, Germany

RECRUITING

Klinikum Köln-Merheim

Cologne, North Rhine-Westphalia, 51109, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Zentralklinik Bad Berka

Bad Berka, Thuringia, 99437, Germany

RECRUITING

Asklepios Klinik Gauting GmbH

Gauting, 82131, Germany

RECRUITING

LungenClinic Grosshansdorf

Großhansdorf, 22927, Germany

RECRUITING

Thoraxklinik-Heidelberg gGmbH

Heidelberg, 69126, Germany

RECRUITING

Robert Bosch Krankenhaus GmbH

Stuttgart, 70736, Germany

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

ACTIVE NOT RECRUITING

Local Institution - 0058

Thessaloniki, Thessaloníki, 570 01, Greece

ACTIVE NOT RECRUITING

Local Institution - 0059

Larissa, Thessalía, 41110, Greece

ACTIVE NOT RECRUITING

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

Mahamana Pandit Madan Mohan Malviya Cancer Centre

Varanasi, Uttar Pradesh, 221005, India

RECRUITING

Netaji Subhas Chandra Bose Cancer Hospital

Kolkata, West Bengal, 700094, India

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

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 0608648, Japan

RECRUITING

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

RECRUITING

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

RECRUITING

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, 236-0051, Japan

RECRUITING

Sendai Kousei Hospital

Sendai, Miyagi, 9810914, Japan

RECRUITING

Nara Medical University Hospital

Kashihara, Nara, 634-8522, Japan

RECRUITING

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191, Japan

RECRUITING

Kindai University Hospital

Ōsaka-sayama, Osaka, 589-8511, Japan

RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

RECRUITING

Saitama Prefectural Cancer Center

Ina-machi, Saitama, 362-0806, Japan

RECRUITING

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 1138603, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Koto, Tokyo, 135-8550, Japan

RECRUITING

Fukushima Medical University

Fukushima, 960-1295, Japan

RECRUITING

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

RECRUITING

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Centro Inmuno-Oncología Occidente

Guadalajara, Jalisco, 44630, Mexico

RECRUITING

Local Institution - 0147

Monterrey, Nuevo León, 66460, Mexico

NOT YET RECRUITING

Unidad Médica Onco-hematológica

Puebla City, 72424, Mexico

RECRUITING

Amsterdam UMC, locatie VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Ziekenhuis Rijnstate

Arnhem, 6815 AD, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Przychodnia Lekarska KOMED

Konin, Greater Poland Voivodeship, 62-500, Poland

RECRUITING

Centrum Medyczne Pratia Poznań

Poznan, Greater Poland Voivodeship, 60-192, Poland

RECRUITING

Szpital Specjalistyczny w Prabutach Spolka z o.o.

Prabuty, Pomeranian Voivodeship, 82-550, Poland

RECRUITING

Local Institution - 0195

Bydgoszcz, 85796, Poland

ACTIVE NOT RECRUITING

Local Institution - 0189

Lodz, Łódź Voivodeship, 93-338, Poland

ACTIVE NOT RECRUITING

SC Memorial Healthcare International SRL

Bucharest, Bucharest, 013812, Romania

RECRUITING

Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

Bucharest, Bucharest, 022328, Romania

RECRUITING

SC Radiotherapy Center Cluj SRL

Florești, Cluj, 407280, Romania

RECRUITING

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, 200542, Romania

RECRUITING

Institutul Oncologic Cluj

Cluj-Napoca, 400015, Romania

RECRUITING

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

Iași, 700106, Romania

RECRUITING

Institutul Regional de Oncologie

Iași, 700483, Romania

RECRUITING

Chungbuk National University Hospital

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

RECRUITING

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

RECRUITING

Ajou University Hospital

Suwon, Kyǒnggi-do, 16499, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

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

RECRUITING

Asan Medical Center

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

RECRUITING

Keimyung University Dongsan Hospital

Daegu, Taegu-Kwangyǒkshi, 42601, South Korea

RECRUITING

CHUS - Hospital Clinico Universitario

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

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], 08041, Spain

RECRUITING

Hospital Universitario de Jaen

Jaén, Jaén, 23007, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Comunidad de, 28222, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Valenciana, Comunitat, 46014, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Kantonsspital Graubünden

Chur, 7000, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

RECRUITING

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

RECRUITING

T.C. Saglik Bakanligi - Izmir Il Saglik Mudurlugu Cigli Bolge Egitim Hastanesi

Çiğli, İzmir, 35620, Turkey (Türkiye)

RECRUITING

Adana City Hospital

Adana, 01370, Turkey (Türkiye)

RECRUITING

Gulhane Egitim Arastirma Hastanesi

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi

Ankara, 06280, Turkey (Türkiye)

RECRUITING

Istanbul Medeniyet University

Istanbul, 34732, Turkey (Türkiye)

RECRUITING

James Cook University Hospital

Central Middlesbrough, Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, AB9 2ZB, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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: April 21, 2026

Record last verified: 2026-04

Data Sharing

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

Locations

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