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Набира участници Фаза 3 NCT06646276

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).

Фаза 3 – широко изпитване преди одобрение
Заболявания: Extensive-Stage Small Cell Lung Cancer

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
BMS-986489 (BMS-986012+Nivolumab)
BIOLOGICAL
Atezolizumab
BIOLOGICAL
Carboplatin
DRUG
Etoposide
DRUG
Места на провеждане 184
Argentina (5)
Hospital Italiano de Buenos Aires
ABB , Buenos Aires F.D.
Yamila Ferreira, Site 0077
Local Institution - 0100
Buenos Aires , Buenos Aires F.D.
WITHDRAWN
Clinica Adventista Belgrano
CABA , Buenos Aires F.D.
Aldo Perfetti, Site 0080
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires , Buenos Aires
Diego Enrico, Site 0079
Instituto Médico Río Cuarto
Río Cuarto , Córdoba Province
Saul Del Grecco, Site 0094
Австралия (5)
Grampians Health
Ballarat Central , Victoria
Wasek Faisal, Site 0190
Gallipoli Medical Research Ltd
Brisbane , Queensland
Kenneth O'Byrne, Site 0105
GenesisCare - Campbelltown
Campbelltown , New South Wales
Jessica Smith, Site 0202
St. John of God Murdoch Hospital
Murdoch , Western Australia
Adeoluwa FREEMAN, Site 0175
Nepean Hospital
Penrith , New South Wales
Deme Karikios, Site 0106
Австрия (4)
Medizinische Universität Graz
Graz , Styria
Nikolaus Kneidinger, Site 0253
Kepler Universitätsklinikum
Linz
David Lang, Site 0252
Landeskrankenhaus Rankweil
Rankweil
Thomas Winder, Site 0255
Klinikum Wels-Grieskirchen GmbH
Wels , Upper Austria
Philipp Vinatzer, Site 0251
Белгия (4)
Cliniques universitaires Saint-Luc
Brussels , Bruxelles-Capitale, Région de
Frank Nana Aboubakar, Site 0198
UZ Gent
Ghent , Oost-Vlaanderen
Veerle Surmont, Site 0091
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège
Anne Sibille, Site 0092
VITAZ
Sint-Niklaas , Oost-Vlaanderen
Koenraad Deschepper, Site 0187
Бразилия (7)
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos , São Paulo
Flavio Augusto Ferreria Da Silva, Site 0178
Hospital São Carlos
Fortaleza , Ceará
Fábio Santos, Site 0166
Clínica de Neoplasias Litoral
Itajaí , Santa Catarina
Giuliano Borges, Site 0163
Hospital de Clinicas de Porto Alegre
Porto Alegre , Rio Grande do Sul
Rodrigo Pereira, Site 0165
Hospital São Lucas da PUCRS
Porto Alegre , Rio Grande do Sul
Ana Caroline Gelatti, Site 0169
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul , Rio Grande do Sul
Bianca Correa Tabajara Weiss, Site 0170
A. C. Camargo Cancer Center
São Paulo , São Paulo
Thiago Oliveira, Site 0111
Канада (4)
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi , Quebec
Marc Trudeau, Site 0290
Cross Cancer Institute
Edmonton , Alberta
Quincy Chu, Site 0289
IUCPQ
Québec , Quebec
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
Rimouski , Quebec
Samuel Nadeau, Site 0287
Chile (5)
Orlandi Oncologia
Santiago , Santiago Metropolitan
Francisco Orlandi, Site 0086
Fundacion Arturo Lopez Perez (FALP)
Santiago , Santiago Metropolitan
Christian Caglevic, Site 0085
Pontificia Universidad Catolica de Chile
Santiago , Santiago Metropolitan
Hector Galindo, Site 0083
Bradfordhill
Santiago , Santiago Metropolitan
Carlos Rojas, Site 0084
Oncocentro Apys
Viña del Mar , Valparaiso
Alejandro Acevedo Gaete, Site 0082
Китай (23)
Beijing Cancer hospital
Beijing , Beijing Municipality
Jun Zhao, Site 0204
Beijing Chest Hospital,Capital Medical University
Beijing , Beijing Municipality
Gen Lin, Site 0336
Jilin Province Tumor Hospital
Changchun , Jilin
Xueying Zhang, Site 0244
Hunan Cancer Hospital
Changsha , Hunan
Lin Wu, Site 0216
Sichuan Cancer hospital
Chengdu , Sichuan
Juan Li, Site 0330
Chongqing University Cancer Hospital
Chongqing , Chongqing Municipality
Huiwen Ma, Site 0203
Fujian Cancer Hospital
Fuzhou , Fujian
Zhiyong He, Site 0308
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou , Zhejiang
Enguo Chen, Site 0236
Zhejiang Cancer Hospital
Hangzhou , Zhejiang
Yun Fan, Site 0237
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
Yan Yu, Site 0227
Shandong Cancer Hospital
Jinan , Shandong
Ligang Xing, Site 0200
Taizhou Hospital of Zhejiang Province
Linhai , Zhejiang
Dongqing LV, Site 0229
The First Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Wei Zhang, Site 0233
Shanghai Chest Hospital
Shanghai , Shanghai Municipality
Hua Zhong, Site 0206
Zhongshan Hospital,Fudan University
Shanghai , Shanghai Municipality
Yuanling Song, Site 0210
Shanghai East Hospital
Shanghai , Shanghai Municipality
Caicun Zhou, Site 0186
Cancer Hospital of Shantou University Medical College
Shantou , Guangdong
Wen Lin, Site 0234
Local Institution - 0235
Shenyang , Liaoning
NOT_YET_RECRUITING
Tianjin Medical University Cancer Institute & Hospital
Tianjin , Tianjin Municipality
Dingzhi Huang, Site 0213
Hubei Cancer Hospital
Wuhan , Hubei
Guang Han, Site 0209
Wuhan Tongji Hospital
Wuhan , Hubei
Qian Chu, Site 0208
Xi'an International Medical Center Hospital
Xi'an , Shaanxi
Kejun Nan, Site 0335
The First Affiliated hospital of Xiamen University
Xiamen , Fujian
Feng Ye, Site 0212
Чехия (4)
Local Institution - 0114
Brno , Brno-město
ACTIVE_NOT_RECRUITING
Local Institution - 0116
Olomouc
ACTIVE_NOT_RECRUITING
Local Institution - 0117
Ostrava , Ostrava Město
ACTIVE_NOT_RECRUITING
Local Institution - 0113
Prague , Praha 4
ACTIVE_NOT_RECRUITING
Франция (10)
Centre Hospitalier Intercommunal de Créteil
Créteil , Val-de-Marne
Christos Chouaid, Site 0047
L Hopital Nord Ouest
Gleizé , Rhône
LIONEL FALCHERO, Site 0044
Chu Grenoble Alpes
La Tronche , Isère
Denis Moro-Sibilot, Site 0040
CHU Lille - Institut Coeur Poumon
Lille , Nord
Arnaud Scherpereel, Site 0052
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille
Laurent Greillier, Site 0043
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier , Hérault
Benoit Roch, Site 0048
Institut Curie
Paris
nicolas girard, Site 0050
Centre Hospitalier Lyon Sud
Pierre-Bénite , Rhône
Sebastien Couraud, Site 0051
Centre Hospitalier de Cornouaille Quimper - Concarneau
Quimper
Romain Corre, Site 0215
Gustave Roussy
Villejuif , Val-de-Marne
Pernelle Lavaud, Site 0038
Германия (9)
Zentralklinik Bad Berka
Bad Berka , Thuringia
Ekkehard Eigendorff, Site 0257
Klinikum Köln-Merheim
Cologne , North Rhine-Westphalia
Eva-Lotte Buchmeier, Site 0261
Krankenhaus Nordwest GmbH
Frankfurt am Main , Hesse
Akin Atmaca, Site 0256
Asklepios Klinik Gauting GmbH
Gauting
Niels Reinmuth, Site 0258
LungenClinic Grosshansdorf
Großhansdorf
Martin Reck, Site 0259
Krankenhaus Martha-Maria Halle-Dölau
Halle , Saxony-Anhalt
Miriam Moeller, Site 0265
Thoraxklinik-Heidelberg gGmbH
Heidelberg
Michael Thomas, Site 0260
Pius Hospital Oldenburg
Oldenburg , Lower Saxony
Frank Griesinger, Site 0262
Robert Bosch Krankenhaus GmbH
Stuttgart
Martin Kimmich, Site 0264
Гърция (5)
Local Institution - 0063
Athens , Attikí
ACTIVE_NOT_RECRUITING
Local Institution - 0064
Athens , Attikí
ACTIVE_NOT_RECRUITING
Local Institution - 0059
Larissa , Thessalía
ACTIVE_NOT_RECRUITING
Local Institution - 0062
Thessaloniki , Kentrikí Makedonía
ACTIVE_NOT_RECRUITING
Local Institution - 0058
Thessaloniki , Thessaloníki
ACTIVE_NOT_RECRUITING
Индия (5)
Local Institution - 0274
Bengaluru , Karnataka
ACTIVE_NOT_RECRUITING
Netaji Subhas Chandra Bose Cancer Hospital
Kolkata , West Bengal
Poulami Basu, Site 0273
Local Institution - 0271
Madurai , Tamil Nadu
ACTIVE_NOT_RECRUITING
Local Institution - 0278
New Delhi , National Capital Territory of Delhi
WITHDRAWN
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Varanasi , Uttar Pradesh
Bipinesh Sansar, Site 0277
Италия (7)
Local Institution - 0074
Bologna
ACTIVE_NOT_RECRUITING
Local Institution - 0068
Milan , Lombardy
ACTIVE_NOT_RECRUITING
Local Institution - 0067
Milan
ACTIVE_NOT_RECRUITING
Local Institution - 0072
Naples , Campania
ACTIVE_NOT_RECRUITING
Local Institution - 0110
Perugia , Umbria
ACTIVE_NOT_RECRUITING
Local Institution - 0070
Peschiera del Garda , Verona
ACTIVE_NOT_RECRUITING
Local Institution - 0069
Rome , Roma
ACTIVE_NOT_RECRUITING
Япония (18)
Nippon Medical School Hospital
Bunkyo-ku , Tokyo
Kazuo Kasahara, Site 0326
Fukushima Medical University
Fukushima
Naoyuki Okabe, Site 0327
Hamamatsu University Hospital
Hamamatsu , Shizuoka
Naoki Inui, Site 0322
Saitama Medical University International Medical Center
Hidaka , Saitama
Hiroshi Kagamu, Site 0320
Kansai Medical University Hospital
Hirakata , Osaka
Takayasu Kurata, Site 0317
Saitama Prefectural Cancer Center
Ina-machi , Saitama
Gen Kida, Site 0318
Kanazawa University Hospital
Kanazawa , Ishikawa-ken
Seiji Yano, Site 0321
Nara Medical University Hospital
Kashihara , Nara
Masayuki Takeda, Site 0324
Kobe City Medical Center General Hospital
Kobe , Hyōgo
Yuki Sato, Site 0323
The Cancer Institute Hospital of JFCR
Koto , Tokyo
Ryo Ariyasu, Site 0315
Kurashiki Central Hospital
Kurashiki , Okayama-ken
Yasushi Fukuda, Site 0328
Kurume University Hospital
Kurume , Fukuoka
Koichi Azuma, Site 0292
National Hospital Organization Shikoku Cancer Center
Matsuyama , Ehime
Takashi Ninomiya, Site 0319
Kindai University Hospital
Ōsaka-sayama , Osaka
Takayuki Takahama, Site 0314
Hokkaido University Hospital
Sapporo , Hokkaido
Yasuyuki Ikezawa, Site 0313
Sendai Kousei Hospital
Sendai , Miyagi
Shunichi Sugawara, Site 0291
Osaka Medical and Pharmaceutical University Hospital
Takatsuki , Osaka
Yasuhito Fujisaka, Site 0325
Kanagawa Cardiovascular and Respiratory Center
Yokohama , Kanagawa
Malaysia (3)
Hospital Kuala Lumpur
Kuala Lumpur , Kuala Lumpur
Prathepamalar Yehgambaram, Site 0310
University Malaya Medical Centre
Kuala Lumpur , Kuala Lumpur
SRI KISHA SUBRAMANIAM, Site 0312
Sarawak General Hospital
Kuching , Sarawak
Pei Jye Voon, Site 0311
Mexico (3)
Centro Inmuno-Oncología Occidente
Guadalajara , Jalisco
Noel Luna-Romero, Site 0146
Local Institution - 0147
Monterrey , Nuevo León
NOT_YET_RECRUITING
Unidad Médica Onco-hematológica
Puebla City
Salvador Macias Diaz, Site 0145
Нидерландия (3)
Amsterdam UMC, locatie VUmc
Amsterdam , North Holland
I Bahce, Site 0097
Ziekenhuis Rijnstate
Arnhem
Niels Claessens, Site 0099
University Medical Center Groningen
Groningen
T.Jeroen Hiltermann, Site 0098
Полша (5)
Local Institution - 0195
Bydgoszcz
ACTIVE_NOT_RECRUITING
Przychodnia Lekarska KOMED
Konin , Greater Poland Voivodeship
Boguslawa Karaszewska, Site 0193
Local Institution - 0189
Lodz , Łódź Voivodeship
ACTIVE_NOT_RECRUITING
Centrum Medyczne Pratia Poznań
Poznan , Greater Poland Voivodeship
Marek Kotlarski, Site 0241
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty , Pomeranian Voivodeship
Anna Lowczak, Site 0192
Румъния (7)
SC Memorial Healthcare International SRL
Bucharest , Bucharest
Ingrid Iordan, Site 0133
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest , Bucharest
Aurelia Alexandru, Site 0135
Institutul Oncologic Cluj
Cluj-Napoca
Tudor Ciuleanu, Site 0141
Centrul de Oncologie "Sfântul Nectarie"
Craiova , Dolj
Michael Schenker, Site 0140
SC Radiotherapy Center Cluj SRL
Florești , Cluj
Andrei Ungureanu, Site 0137
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași
Constantin Volovat, Site 0139
Institutul Regional de Oncologie
Iași
Dana Clement, Site 0132
Южна Корея (6)
Chungbuk National University Hospital
Cheongju-si , Chungcheongbuk-do [Chungbuk]
Ki Hyeong Lee, Site 0305
Keimyung University Dongsan Hospital
Daegu , Taegu-Kwangyǒkshi
Keon Park, Site 0309
Seoul National University Bundang Hospital
Seongnam , Kyǒnggi-do
Yu Jung Kim, Site 0286
Severance Hospital, Yonsei University Health System
Seoul , Seoul-teukbyeolsi [Seoul]
Byoung Chul Cho, Site 0285
Asan Medical Center
Seoul , Seoul-teukbyeolsi [Seoul]
Dae Ho Lee, Site 0293
Ajou University Hospital
Suwon , Kyǒnggi-do
Hyun Woo Lee, Site 0304
Испания (10)
Hospital Clínic de Barcelona
Barcelona , Catalunya [Cataluña]
Laura Mezquita Perez, Site 0294
Hospital de la Santa Creu i Sant Pau
Barcelona , Catalunya [Cataluña]
Margarita Majem Tarruella, Site 0302
Hospital Universitario de Jaen
Jaén , Jaén
Ana Laura Ortega Granados, Site 0301
Hospital Universitario Ramón y Cajal
Madrid , Madrid, Comunidad de
Maria Eugenia Olmedo Garcia, Site 0298
Hospital Universitario 12 de Octubre
Madrid , Madrid, Comunidad de
Luis Paz-Ares Rodriguez, Site 0296
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , Madrid, Comunidad de
Mariano Provencio Pulla, Site 0297
CHUS - Hospital Clinico Universitario
Santiago de Compostela , A Coruña [La Coruña]
Jorge Garcia Gonzalez, Site 0300
Hospital Universitario Virgen Macarena
Seville
David Vicente Baz, Site 0299
Hospital Universitario Virgen Del Rocio
Seville
Reyes Bernabe Caro, Site 0295
Hospital General Universitario de Valencia
Valencia , Valenciana, Comunitat
Paula Espinosa Olarte, Site 0303
Швейцария (3)
Kantonsspital Graubünden
Chur
Michael Mark, Site 0248
Kantonsspital Winterthur
Winterthur
Laetitia Mauti, Site 0249
UniversitätsSpital Zürich
Zurich
Ulrich Richter, Site 0247
Турция (5)
Adana City Hospital
Adana
Timucin Cil, Site 0154
Gulhane Egitim Arastirma Hastanesi
Ankara
Nuri Karadurmus, Site 0157
Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi
Ankara
Serdar Karakaya, Site 0177
T.C. Saglik Bakanligi - Izmir Il Saglik Mudurlugu Cigli Bolge Egitim Hastanesi
Çiğli , İzmir
Murat Akyol, Site 0158
Istanbul Medeniyet University
Istanbul
Mahmut Gumus, Site 0153
Великобритания (4)
Aberdeen Royal Infirmary
Aberdeen
Gillian Price, Site 0159
James Cook University Hospital
Central Middlesbrough , Middlesbrough
Talal Mansy, Site 0183
The Christie NHS Foundation Trust
Manchester
Raffaele Califano, Site 0101
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral
Carles Escriu, Site 0226
САЩ (20)
University of New Mexico Comprehensive Cancer Center
Albuquerque , New Mexico
Moises Harari-Turquie, Site 0033
Texas Oncology - Central/South Texas
Austin , Texas
James Uyeki, Site 0001
Sanford Medical Center
Bismarck , North Dakota
Thandiwe Gray, Site 0232
Oncology Hematology Care
Cincinnati , Ohio
Patrick Ward, Site 0284
Southern Cancer Center, PC
Daphne , Alabama
Michael Meshad, Site 0337
Duke Cancer Institute
Durham , North Carolina
Neal Ready, Site 0029
Swedish Cancer Institute - Edmonds
Edmonds , Washington
Siddhartha Devarakonda, Site 0339
Local Institution - 0010
Fargo , North Dakota
NOT_YET_RECRUITING
Florida Cancer Specialists - South
Fort Myers , Florida
Alexander Glick, Site 0245
Local Institution - 0283
Hot Springs , Arkansas
COMPLETED
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta , Georgia
Walid Shaib, Site 0013
Local Institution - 0037
Minneapolis , Minnesota
WITHDRAWN
SCRI Oncology Partners
Nashville , Tennessee
Melissa Johnson, Site 0008
Mid Florida Hematology and Oncology Center
Orange City , Florida
Santosh Nair, Site 0009
Illinois Cancer Care
Peoria , Illinois
Gary MacVicar, Site 0019
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke , Virginia
Jerome Goldschmidt, Site 0246
Swedish Medical Center
Seattle , Washington
Siddhartha Devarakonda, Site 0026
Sanford Cancer Center
Sioux Falls , South Dakota
Allison Watson, Site 0231
Florida Cancer Specialists - North
St. Petersburg , Florida
Maen Hussein, Site 0020
Texas Oncology - Northeast Texas
Tyler , Texas
Sarah Wang, Site 0281
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
25.02.2025
Крайна дата
05.09.2031
Регистрационен номер
NCT06646276
Източник
clinicaltrials.gov
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