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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986489 (BMS-986012+Nivolumab) | Biological | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center, PC | Recruiting | Daphne | Alabama | 36526 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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
See Plan Description
See Plan Description
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| Atezolizumab |
| Biological |
Specified dose on specified days |
|
| Carboplatin | Drug | Specified dose on specified days |
|
| Etoposide | Drug | Specified dose on specified days |
|
| 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 |
| Duration of Response (DOR) | Up to 5 years |
| Progression Free Survival (PFS) | Up to 5 years |
| Local Institution - 0283 | Completed | Hot Springs | Arkansas | 71913 | United States |
| Florida Cancer Specialists - South | Recruiting | Fort Myers | Florida | 33901 | United States |
|
| Mid Florida Hematology and Oncology Center | Recruiting | Orange City | Florida | 32763 | United States |
|
| Florida Cancer Specialists - North | Recruiting | St. Petersburg | Florida | 33705 | United States |
|
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Recruiting | Marietta | Georgia | 30060 | United States |
|
| Illinois Cancer Care | Recruiting | Peoria | Illinois | 61615 | United States |
|
| Local Institution - 0037 | Withdrawn | Minneapolis | Minnesota | 55407 | United States |
| University of New Mexico Comprehensive Cancer Center | Recruiting | Albuquerque | New Mexico | 87106 | United States |
|
| Duke Cancer Institute | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Sanford Medical Center | Recruiting | Bismarck | North Dakota | 58501 | United States |
|
| Sanford Fargo Medical Center | Recruiting | Fargo | North Dakota | 58102 | United States |
|
| Oncology Hematology Care | Recruiting | Cincinnati | Ohio | 45242 | United States |
|
| Sanford Cancer Center | Recruiting | Sioux Falls | South Dakota | 57104 | United States |
|
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Texas Oncology - Central/South Texas | Recruiting | Austin | Texas | 78705 | United States |
|
| Texas Oncology - Northeast Texas | Recruiting | Tyler | Texas | 75702 | United States |
|
| Oncology & Hematology Associates of Southwest Virginia, Inc. | Recruiting | Roanoke | Virginia | 24014 | United States |
|
| Swedish Cancer Institute - Edmonds | Recruiting | Edmonds | Washington | 98026 | United States |
|
| Swedish Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
|
| Local Institution - 0079 | Completed | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1426ANZ | Argentina |
| Local Institution - 0077 | Completed | ABB | Buenos Aires F.D. | C1199ABB | Argentina |
| Local Institution - 0100 | Withdrawn | Buenos Aires | Buenos Aires F.D. | C1417DTB | Argentina |
| Local Institution - 0080 | Active, not recruiting | CABA | Buenos Aires F.D. | C1430EGF | Argentina |
| Local Institution - 0094 | Active, not recruiting | Río Cuarto | Córdoba Province | X5800AEV | Argentina |
| Local Institution - 0202 | Active, not recruiting | Campbelltown | New South Wales | 2560 | Australia |
| Local Institution - 0106 | Active, not recruiting | Penrith | New South Wales | 2750 | Australia |
| Local Institution - 0105 | Active, not recruiting | Brisbane | Queensland | 4120 | Australia |
| Local Institution - 0190 | Active, not recruiting | Ballarat Central | Victoria | 3350 | Australia |
| Local Institution - 0175 | Active, not recruiting | Murdoch | Western Australia | 6150 | Australia |
| Local Institution - 0253 | Active, not recruiting | Graz | Styria | 8036 | Austria |
| Local Institution - 0251 | Active, not recruiting | Wels | Upper Austria | 4600 | Austria |
| Local Institution - 0252 | Active, not recruiting | Linz | 4021 | Austria |
| Local Institution - 0255 | Active, not recruiting | Rankweil | 6830 | Austria |
| Local Institution - 0198 | Active, not recruiting | Brussels | Bruxelles-Capitale, Région de | 1200 | Belgium |
| Local Institution - 0091 | Active, not recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Local Institution - 0187 | Active, not recruiting | Sint-Niklaas | Oost-Vlaanderen | B-9100 | Belgium |
| Local Institution - 0092 | Active, not recruiting | Liège | 4000 | Belgium |
| Local Institution - 0166 | Active, not recruiting | Fortaleza | Ceará | 60135-237 | Brazil |
| Local Institution - 0165 | Active, not recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Local Institution - 0169 | Active, not recruiting | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Local Institution - 0170 | Completed | Santa Cruz do Sul | Rio Grande do Sul | 96830-180 | Brazil |
| Local Institution - 0163 | Active, not recruiting | Itajaí | Santa Catarina | 88301-220 | Brazil |
| Local Institution - 0178 | Active, not recruiting | Barretos | São Paulo | 14784400 | Brazil |
| Local Institution - 0111 | Active, not recruiting | São Paulo | São Paulo | 01509-010 | Brazil |
| Local Institution - 0289 | Active, not recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0290 | Active, not recruiting | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Local Institution - 0288 | Active, not recruiting | Québec | Quebec | G1V 4G5 | Canada |
| Local Institution - 0287 | Active, not recruiting | Rimouski | Quebec | G5L 5T1 | Canada |
| Local Institution - 0086 | Active, not recruiting | Santiago | Santiago Metropolitan | 0 | Chile |
| Local Institution - 0085 | Active, not recruiting | Santiago | Santiago Metropolitan | 7500921 | Chile |
| Local Institution - 0083 | Active, not recruiting | Santiago | Santiago Metropolitan | 8330032 | Chile |
| Local Institution - 0084 | Active, not recruiting | Santiago | Santiago Metropolitan | 8420383 | Chile |
| Local Institution - 0082 | Active, not recruiting | Viña del Mar | Valparaiso | 2520598 | Chile |
| Local Institution - 0204 | Completed | Beijing | Beijing Municipality | 100142 | China |
| Local Institution - 0336 | Active, not recruiting | Beijing | Beijing Municipality | 101149 | China |
| Local Institution - 0203 | Active, not recruiting | Chongqing | Chongqing Municipality | 400030 | China |
| Local Institution - 0308 | Active, not recruiting | Fuzhou | Fujian | 350014 | China |
| Local Institution - 0212 | Completed | Xiamen | Fujian | 361003 | China |
| Local Institution - 0234 | Active, not recruiting | Shantou | Guangdong | 515000 | China |
| Local Institution - 0227 | Active, not recruiting | Harbin | Heilongjiang | 150081 | China |
| Local Institution - 0209 | Active, not recruiting | Wuhan | Hubei | 430079 | China |
| Local Institution - 0208 | Active, not recruiting | Wuhan | Hubei | 430100 | China |
| Local Institution - 0216 | Active, not recruiting | Changsha | Hunan | 410013 | China |
| Local Institution - 0233 | Active, not recruiting | Nanchang | Jiangxi | 330006 | China |
| Local Institution - 0244 | Active, not recruiting | Changchun | Jilin | 132000 | China |
| Local Institution - 0235 | Not yet recruiting | Shenyang | Liaoning | 110042 | China |
|
| Local Institution - 0335 | Completed | Xi'an | Shaanxi | 710126 | China |
| Local Institution - 0200 | Active, not recruiting | Jinan | Shandong | 250117 | China |
| Local Institution - 0206 | Active, not recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| Local Institution - 0210 | Active, not recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Local Institution - 0186 | Active, not recruiting | Shanghai | Shanghai Municipality | 200120 | China |
| Local Institution - 0330 | Active, not recruiting | Chengdu | Sichuan | 610041 | China |
| Local Institution - 0213 | Active, not recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| Local Institution - 0236 | Active, not recruiting | Hangzhou | Zhejiang | 310016 | China |
| Local Institution - 0237 | Active, not recruiting | Hangzhou | Zhejiang | 310022 | China |
| Local Institution - 0229 | Active, not recruiting | Linhai | Zhejiang | 317000 | China |
| Local Institution - 0114 | Active, not recruiting | Brno | Brno-město | 656 53 | Czechia |
| Local Institution - 0117 | Active, not recruiting | Ostrava | Ostrava Město | 703 00 | Czechia |
| Local Institution - 0113 | Active, not recruiting | Prague | Praha 4 | 14059 | Czechia |
| Local Institution - 0116 | Active, not recruiting | Olomouc | 779 00 | Czechia |
| Local Institution - 0048 | Completed | Montpellier | Hérault | 34090 | France |
| Local Institution - 0040 | Active, not recruiting | La Tronche | Isère | 38700 | France |
| Local Institution - 0052 | Completed | Lille | Nord | 59037 | France |
| Local Institution - 0044 | Completed | Gleizé | Rhône | 69400 | France |
| Local Institution - 0051 | Active, not recruiting | Pierre-Bénite | Rhône | 69310 | France |
| Local Institution - 0047 | Completed | Créteil | Val-de-Marne | 94010 | France |
| Local Institution - 0038 | Active, not recruiting | Villejuif | Val-de-Marne | 94800 | France |
| Local Institution - 0043 | Active, not recruiting | Marseille | 13915 | France |
| Local Institution - 0050 | Active, not recruiting | Paris | 75248 | France |
| Local Institution - 0215 | Active, not recruiting | Quimper | 29000 | France |
| Local Institution - 0256 | Active, not recruiting | Frankfurt am Main | Hesse | 60488 | Germany |
| Local Institution - 0262 | Active, not recruiting | Oldenburg | Lower Saxony | 26121 | Germany |
| Local Institution - 0261 | Active, not recruiting | Cologne | North Rhine-Westphalia | 51109 | Germany |
| Local Institution - 0265 | Active, not recruiting | Halle | Saxony-Anhalt | 06120 | Germany |
| Local Institution - 0257 | Active, not recruiting | Bad Berka | Thuringia | 99437 | Germany |
| Local Institution - 0258 | Completed | Gauting | 82131 | Germany |
| Local Institution - 0259 | Active, not recruiting | Großhansdorf | 22927 | Germany |
| Thoraxklinik-Heidelberg gGmbH | Recruiting | Heidelberg | 69126 | Germany |
|
| Local Institution - 0264 | Active, not recruiting | Stuttgart | 70736 | Germany |
| Local Institution - 0063 | Active, not recruiting | Athens | Attikí | 115 26 | Greece |
| Local Institution - 0064 | Active, not recruiting | Athens | Attikí | 115 27 | Greece |
| Local Institution - 0062 | Completed | Thessaloniki | Kentrikí Makedonía | 540 07 | Greece |
| Local Institution - 0058 | Active, not recruiting | Thessaloniki | Thessaloníki | 570 01 | Greece |
| Local Institution - 0059 | Completed | Larissa | Thessalía | 41110 | Greece |
| Local Institution - 0274 | Active, not recruiting | Bengaluru | Karnataka | 560017 | India |
| Local Institution - 0278 | Withdrawn | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Local Institution - 0271 | Active, not recruiting | Madurai | Tamil Nadu | 625107 | India |
| Local Institution - 0277 | Active, not recruiting | Varanasi | Uttar Pradesh | 221005 | India |
| Local Institution - 0273 | Active, not recruiting | Kolkata | West Bengal | 700094 | India |
| Local Institution - 0072 | Active, not recruiting | Naples | Campania | 80131 | Italy |
| Local Institution - 0068 | Active, not recruiting | Milan | Lombardy | 20133 | Italy |
| Local Institution - 0069 | Active, not recruiting | Rome | Roma | 00144 | Italy |
| Local Institution - 0110 | Active, not recruiting | Perugia | Umbria | 06132 | Italy |
| Local Institution - 0070 | Active, not recruiting | Peschiera del Garda | Verona | 37019 | Italy |
| Local Institution - 0074 | Active, not recruiting | Bologna | 40138 | Italy |
| Local Institution - 0067 | Active, not recruiting | Milan | 20141 | Italy |
| Local Institution - 0319 | Active, not recruiting | Matsuyama | Ehime | 791-0280 | Japan |
| Local Institution - 0292 | Active, not recruiting | Kurume | Fukuoka | 830-0011 | Japan |
| Local Institution - 0313 | Active, not recruiting | Sapporo | Hokkaido | 0608648 | Japan |
| Local Institution - 0323 | Active, not recruiting | Kobe | Hyōgo | 650-0047 | Japan |
| Local Institution - 0321 | Active, not recruiting | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Local Institution - 0316 | Completed | Yokohama | Kanagawa | 236-0051 | Japan |
| Local Institution - 0291 | Active, not recruiting | Sendai | Miyagi | 9810914 | Japan |
| Local Institution - 0324 | Completed | Kashihara | Nara | 634-8522 | Japan |
| Local Institution - 0328 | Active, not recruiting | Kurashiki | Okayama-ken | 710-8602 | Japan |
| Local Institution - 0317 | Active, not recruiting | Hirakata | Osaka | 573-1191 | Japan |
| Local Institution - 0314 | Active, not recruiting | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| Local Institution - 0325 | Completed | Takatsuki | Osaka | 569-8686 | Japan |
| Local Institution - 0320 | Active, not recruiting | Hidaka | Saitama | 350-1298 | Japan |
| Local Institution - 0318 | Active, not recruiting | Ina-machi | Saitama | 362-0806 | Japan |
| Local Institution - 0322 | Active, not recruiting | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Local Institution - 0326 | Active, not recruiting | Bunkyo-ku | Tokyo | 1138603 | Japan |
| Local Institution - 0315 | Active, not recruiting | Koto | Tokyo | 135-8550 | Japan |
| Local Institution - 0327 | Active, not recruiting | Fukushima | 960-1295 | Japan |
| Hospital Kuala Lumpur | Recruiting | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
|
| Local Institution - 0312 | Completed | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
| Local Institution - 0311 | Active, not recruiting | Kuching | Sarawak | 93586 | Malaysia |
| Local Institution - 0146 | Active, not recruiting | Guadalajara | Jalisco | 44630 | Mexico |
| Local Institution - 0145 | Completed | Puebla City | 72424 | Mexico |
| Local Institution - 0097 | Completed | Amsterdam | North Holland | 1081 HV | Netherlands |
| Local Institution - 0099 | Active, not recruiting | Arnhem | 6815 AD | Netherlands |
| Local Institution - 0098 | Active, not recruiting | Groningen | 9713 GZ | Netherlands |
| Local Institution - 0193 | Active, not recruiting | Konin | Greater Poland Voivodeship | 62-500 | Poland |
| Local Institution - 0241 | Active, not recruiting | Poznan | Greater Poland Voivodeship | 60-192 | Poland |
| Local Institution - 0192 | Active, not recruiting | Prabuty | Pomeranian Voivodeship | 82-550 | Poland |
| Local Institution - 0195 | Active, not recruiting | Bydgoszcz | 85796 | Poland |
| Local Institution - 0189 | Active, not recruiting | Lodz | Łódź Voivodeship | 93-338 | Poland |
| Local Institution - 0133 | Active, not recruiting | Bucharest | Bucharest | 013812 | Romania |
| Local Institution - 0135 | Active, not recruiting | Bucharest | Bucharest | 022328 | Romania |
| Local Institution - 0137 | Active, not recruiting | Florești | Cluj | 407280 | Romania |
| Local Institution - 0140 | Active, not recruiting | Craiova | Dolj | 200542 | Romania |
| Local Institution - 0141 | Active, not recruiting | Cluj-Napoca | 400015 | Romania |
| S.C. Centrul de Oncologie Euroclinic S.R.L. | Recruiting | Iași | 700106 | Romania |
|
| Institutul Regional de Oncologie | Recruiting | Iași | 700483 | Romania |
|
| Local Institution - 0305 | Active, not recruiting | Cheongju-si | Chungcheongbuk-do [Chungbuk] | 28644 | South Korea |
| Local Institution - 0286 | Active, not recruiting | Seongnam | Kyǒnggi-do | 13620 | South Korea |
| Local Institution - 0304 | Active, not recruiting | Suwon | Kyǒnggi-do | 16499 | South Korea |
| Local Institution - 0285 | Active, not recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 03722 | South Korea |
| Local Institution - 0293 | Active, not recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Local Institution - 0309 | Active, not recruiting | Daegu | Taegu-Kwangyǒkshi | 42601 | South Korea |
| Local Institution - 0300 | Active, not recruiting | Santiago de Compostela | A Coruña [La Coruña] | 15706 | Spain |
| Local Institution - 0294 | Completed | Barcelona | Catalunya [Cataluña] | 08036 | Spain |
| Local Institution - 0302 | Active, not recruiting | Barcelona | Catalunya [Cataluña] | 08041 | Spain |
| Local Institution - 0301 | Active, not recruiting | Jaén | Jaén | 23007 | Spain |
| Local Institution - 0298 | Active, not recruiting | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Local Institution - 0296 | Active, not recruiting | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Local Institution - 0297 | Active, not recruiting | Majadahonda | Madrid, Comunidad de | 28222 | Spain |
| Local Institution - 0303 | Active, not recruiting | Valencia | Valenciana, Comunitat | 46014 | Spain |
| Local Institution - 0299 | Active, not recruiting | Seville | 41009 | Spain |
| Local Institution - 0295 | Active, not recruiting | Seville | 41013 | Spain |
| Local Institution - 0248 | Active, not recruiting | Chur | 7000 | Switzerland |
| Local Institution - 0249 | Active, not recruiting | Winterthur | 8401 | Switzerland |
| Local Institution - 0247 | Active, not recruiting | Zurich | 8091 | Switzerland |
| Local Institution - 0158 | Active, not recruiting | Çiğli | İzmir | 35620 | Turkey (Türkiye) |
| Local Institution - 0154 | Active, not recruiting | Adana | 01370 | Turkey (Türkiye) |
| Local Institution - 0157 | Active, not recruiting | Ankara | 06010 | Turkey (Türkiye) |
| Local Institution - 0177 | Active, not recruiting | Ankara | 06280 | Turkey (Türkiye) |
| Local Institution - 0153 | Active, not recruiting | Istanbul | 34732 | Turkey (Türkiye) |
| Local Institution - 0183 | Completed | Central Middlesbrough | Middlesbrough | TS4 3BW | United Kingdom |
| Local Institution - 0159 | Completed | Aberdeen | AB9 2ZB | United Kingdom |
| Local Institution - 0101 | Active, not recruiting | Manchester | M20 4BX | United Kingdom |
| Local Institution - 0226 | Active, not recruiting | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided