Trial Title:
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).
NCT ID:
NCT06646276
Condition:
Extensive-Stage Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Nivolumab
Etoposide
Atezolizumab
Conditions: Keywords:
BMS-986489
BMS-986012
Extensive-Stage Small Cell Lung Cancer
Etoposide
Carboplatin
Nivolumab
TIGOS
fucGM1
SCLC
ES-SCLC
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
BMS-986489 (BMS-986012+Nivolumab)
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Biological
Intervention name:
Atezolizumab
Description:
Specified dose on specified days
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Specified dose on specified days
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Specified dose on specified days
Arm group label:
Arm A
Arm group label:
Arm B
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0245
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Contact:
Last name:
Site 0245
Facility:
Name:
Local Institution - 0009
Address:
City:
Orange City
Zip:
32763
Country:
United States
Contact:
Last name:
Site 0009
Facility:
Name:
Local Institution - 0020
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Contact:
Last name:
Site 0020
Facility:
Name:
Local Institution - 0013
Address:
City:
Marietta
Zip:
30060
Country:
United States
Contact:
Last name:
Site 0013
Facility:
Name:
Local Institution - 0037
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Contact:
Last name:
Site 0037
Facility:
Name:
Local Institution - 0033
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Contact:
Last name:
Site 0033
Facility:
Name:
Local Institution - 0029
Address:
City:
Durham
Zip:
27710
Country:
United States
Contact:
Last name:
Site 0029
Facility:
Name:
Local Institution - 0284
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Contact:
Last name:
Site 0284
Facility:
Name:
Local Institution - 0231
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Contact:
Last name:
Site 0231
Facility:
Name:
Local Institution - 0307
Address:
City:
Knoxville
Zip:
37909
Country:
United States
Contact:
Last name:
Site 0307
Facility:
Name:
Local Institution - 0008
Address:
City:
Nashville
Zip:
37203
Country:
United States
Contact:
Last name:
Site 0008
Facility:
Name:
Local Institution - 0001
Address:
City:
Austin
Zip:
78731
Country:
United States
Contact:
Last name:
Site 0001
Facility:
Name:
Local Institution - 0281
Address:
City:
Tyler
Zip:
75702
Country:
United States
Contact:
Last name:
Site 0281
Facility:
Name:
Local Institution - 0246
Address:
City:
Blacksburg
Zip:
24060
Country:
United States
Contact:
Last name:
Site 0246
Facility:
Name:
Local Institution - 0026
Address:
City:
Seattle
Zip:
98104
Country:
United States
Contact:
Last name:
Site 0026
Facility:
Name:
Local Institution - 0007
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Contact:
Last name:
Site 0007
Facility:
Name:
Local Institution - 0079
Address:
City:
Ciudad Autónoma de Buenos Aires
Zip:
C1426ANZ
Country:
Argentina
Contact:
Last name:
Site 0079
Facility:
Name:
Local Institution - 0077
Address:
City:
ABB
Zip:
C1199ABB
Country:
Argentina
Contact:
Last name:
Site 0077
Facility:
Name:
Local Institution - 0100
Address:
City:
Buenos Aires
Zip:
C1417DTB
Country:
Argentina
Contact:
Last name:
Site 0100
Facility:
Name:
Local Institution - 0080
Address:
City:
Caba
Zip:
C1430EGF
Country:
Argentina
Contact:
Last name:
Site 0080
Facility:
Name:
Local Institution - 0094
Address:
City:
Río Cuarto
Zip:
X5800AEV
Country:
Argentina
Contact:
Last name:
Site 0094
Facility:
Name:
Local Institution - 0202
Address:
City:
Campbelltown
Zip:
2560
Country:
Australia
Contact:
Last name:
Site 0202
Facility:
Name:
Local Institution - 0106
Address:
City:
Penrith
Zip:
2750
Country:
Australia
Contact:
Last name:
Site 0106
Facility:
Name:
Local Institution - 0105
Address:
City:
Brisbane
Zip:
4120
Country:
Australia
Contact:
Last name:
Site 0105
Facility:
Name:
Local Institution - 0190
Address:
City:
Ballarat Central
Zip:
3350
Country:
Australia
Contact:
Last name:
Site 0190
Facility:
Name:
Local Institution - 0175
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Contact:
Last name:
Site 0175
Facility:
Name:
Local Institution - 0251
Address:
City:
Wels
Zip:
4600
Country:
Austria
Contact:
Last name:
Site 0251
Facility:
Name:
Local Institution - 0253
Address:
City:
Graz
Zip:
8036
Country:
Austria
Contact:
Last name:
Site 0253
Facility:
Name:
Local Institution - 0252
Address:
City:
Linz
Zip:
4021
Country:
Austria
Contact:
Last name:
Site 0252
Facility:
Name:
Local Institution - 0255
Address:
City:
Rankweil
Zip:
6830
Country:
Austria
Contact:
Last name:
Site 0255
Facility:
Name:
Local Institution - 0250
Address:
City:
Wien
Zip:
1210
Country:
Austria
Contact:
Last name:
Site 0250
Facility:
Name:
Local Institution - 0091
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Contact:
Last name:
Site 0091
Facility:
Name:
Local Institution - 0187
Address:
City:
Sint-Niklaas
Zip:
B-9100
Country:
Belgium
Contact:
Last name:
Site 0187
Facility:
Name:
Local Institution - 0180
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Contact:
Last name:
Site 0180
Facility:
Name:
Local Institution - 0092
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Contact:
Last name:
Site 0092
Facility:
Name:
Local Institution - 0166
Address:
City:
Fortaleza
Zip:
60135-237
Country:
Brazil
Contact:
Last name:
Site 0166
Facility:
Name:
Local Institution - 0165
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Contact:
Last name:
Site 0165
Facility:
Name:
Local Institution - 0169
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Contact:
Last name:
Site 0169
Facility:
Name:
Local Institution - 0170
Address:
City:
Santa Cruz do Sul
Zip:
96830-180
Country:
Brazil
Contact:
Last name:
Site 0170
Facility:
Name:
Local Institution - 0163
Address:
City:
Itajaí
Zip:
88301-220
Country:
Brazil
Contact:
Last name:
Site 0163
Facility:
Name:
Local Institution - 0178
Address:
City:
Barretos
Zip:
14784400
Country:
Brazil
Contact:
Last name:
Site 0178
Facility:
Name:
Local Institution - 0111
Address:
City:
Sao Paulo
Zip:
01509-010
Country:
Brazil
Contact:
Last name:
Site 0111
Facility:
Name:
Local Institution - 0289
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Contact:
Last name:
Site 0289
Facility:
Name:
Local Institution - 0290
Address:
City:
Chicoutimi
Zip:
G7H 5H6
Country:
Canada
Contact:
Last name:
Site 0290
Facility:
Name:
Local Institution - 0287
Address:
City:
Rimouski
Zip:
G5L 5T1
Country:
Canada
Contact:
Last name:
Site 0287
Facility:
Name:
Local Institution - 0288
Address:
City:
Quebec
Zip:
GIV4G5
Country:
Canada
Contact:
Last name:
Site 0288
Facility:
Name:
Local Institution - 0086
Address:
City:
Santiago
Zip:
0
Country:
Chile
Contact:
Last name:
Site 0086
Facility:
Name:
Local Institution - 0085
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Contact:
Last name:
Site 0085
Facility:
Name:
Local Institution - 0083
Address:
City:
Santiago
Zip:
8330032
Country:
Chile
Contact:
Last name:
Site 0083
Facility:
Name:
Local Institution - 0084
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Contact:
Last name:
Site 0084
Facility:
Name:
Local Institution - 0082
Address:
City:
Viña del Mar
Zip:
2520598
Country:
Chile
Contact:
Last name:
Site 0082
Facility:
Name:
Local Institution - 0114
Address:
City:
Brno
Zip:
656 53
Country:
Czechia
Contact:
Last name:
Site 0114
Facility:
Name:
Local Institution - 0117
Address:
City:
Ostrava
Zip:
703 00
Country:
Czechia
Contact:
Last name:
Site 0117
Facility:
Name:
Local Institution - 0113
Address:
City:
Prague
Zip:
14059
Country:
Czechia
Contact:
Last name:
Site 0113
Facility:
Name:
Local Institution - 0116
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Contact:
Last name:
Site 0116
Facility:
Name:
Local Institution - 0048
Address:
City:
Montpellier
Zip:
34090
Country:
France
Contact:
Last name:
Site 0048
Facility:
Name:
Local Institution - 0040
Address:
City:
La Tronche
Zip:
38700
Country:
France
Contact:
Last name:
Site 0040
Facility:
Name:
Local Institution - 0052
Address:
City:
Lille
Zip:
59037
Country:
France
Contact:
Last name:
Site 0052
Facility:
Name:
Local Institution - 0044
Address:
City:
Gleize
Zip:
69400
Country:
France
Contact:
Last name:
Site 0044
Facility:
Name:
Local Institution - 0051
Address:
City:
Pierre-Bénite
Zip:
69310
Country:
France
Contact:
Last name:
Site 0051
Facility:
Name:
Local Institution - 0047
Address:
City:
Créteil
Zip:
94010
Country:
France
Contact:
Last name:
Site 0047
Facility:
Name:
Local Institution - 0038
Address:
City:
Villejuif
Zip:
94800
Country:
France
Contact:
Last name:
Site 0038
Facility:
Name:
Local Institution - 0043
Address:
City:
Marseille
Zip:
13915
Country:
France
Contact:
Last name:
Site 0043
Facility:
Name:
Local Institution - 0050
Address:
City:
Paris
Zip:
75248
Country:
France
Contact:
Last name:
Site 0050
Facility:
Name:
Local Institution - 0215
Address:
City:
Quimper
Zip:
29000
Country:
France
Contact:
Last name:
Site 0215
Facility:
Name:
Local Institution - 0256
Address:
City:
Frankfurt
Zip:
60488
Country:
Germany
Contact:
Last name:
Site 0256
Facility:
Name:
Local Institution - 0262
Address:
City:
Oldenburg
Zip:
26121
Country:
Germany
Contact:
Last name:
Site 0262
Facility:
Name:
Local Institution - 0261
Address:
City:
Köln
Zip:
51109
Country:
Germany
Contact:
Last name:
Site 0261
Facility:
Name:
Local Institution - 0265
Address:
City:
Halle
Zip:
06120
Country:
Germany
Contact:
Last name:
Site 0265
Facility:
Name:
Local Institution - 0257
Address:
City:
Bad Berka
Zip:
99437
Country:
Germany
Contact:
Last name:
Site 0257
Facility:
Name:
Local Institution - 0263
Address:
City:
Berlin
Zip:
14165
Country:
Germany
Contact:
Last name:
Site 0263
Facility:
Name:
Local Institution - 0258
Address:
City:
Gauting
Zip:
82131
Country:
Germany
Contact:
Last name:
Site 0258
Facility:
Name:
Local Institution - 0259
Address:
City:
Grosshansdorf
Zip:
22927
Country:
Germany
Contact:
Last name:
Site 0259
Facility:
Name:
Local Institution - 0264
Address:
City:
Stuttgart
Zip:
70736
Country:
Germany
Contact:
Last name:
Site 0264
Facility:
Name:
Local Institution - 0063
Address:
City:
Athens
Zip:
115 26
Country:
Greece
Contact:
Last name:
Site 0063
Facility:
Name:
Local Institution - 0064
Address:
City:
Athens
Zip:
115 27
Country:
Greece
Contact:
Last name:
Site 0064
Facility:
Name:
Local Institution - 0062
Address:
City:
Thessaloniki
Zip:
540 07
Country:
Greece
Contact:
Last name:
Site 0062
Facility:
Name:
Local Institution - 0058
Address:
City:
Thessaloniki
Zip:
570 01
Country:
Greece
Contact:
Last name:
Site 0058
Facility:
Name:
Local Institution - 0059
Address:
City:
Larissa
Zip:
41110
Country:
Greece
Contact:
Last name:
Site 0059
Facility:
Name:
Local Institution - 0278
Address:
City:
New Delhi
Zip:
110029
Country:
India
Contact:
Last name:
Site 0278
Facility:
Name:
Local Institution - 0274
Address:
City:
Bengaluru
Zip:
560017
Country:
India
Contact:
Last name:
Site 0274
Facility:
Name:
Local Institution - 0271
Address:
City:
Madurai
Zip:
625107
Country:
India
Contact:
Last name:
Site 0271
Facility:
Name:
Local Institution - 0277
Address:
City:
Varanasi
Zip:
221005
Country:
India
Contact:
Last name:
Site 0277
Facility:
Name:
Local Institution - 0273
Address:
City:
Kolkata
Zip:
700094
Country:
India
Contact:
Last name:
Site 0273
Facility:
Name:
Local Institution - 0072
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Contact:
Last name:
Site 0072
Facility:
Name:
Local Institution - 0068
Address:
City:
Milan
Zip:
20133
Country:
Italy
Contact:
Last name:
Site 0068
Facility:
Name:
Local Institution - 0069
Address:
City:
Rome
Zip:
00144
Country:
Italy
Contact:
Last name:
Site 0069
Facility:
Name:
Local Institution - 0110
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Contact:
Last name:
Site 0110
Facility:
Name:
Local Institution - 0070
Address:
City:
Peschiera del Garda
Zip:
37019
Country:
Italy
Contact:
Last name:
Site 0070
Facility:
Name:
Local Institution - 0074
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Contact:
Last name:
Site 0074
Facility:
Name:
Local Institution - 0067
Address:
City:
Milano
Zip:
20141
Country:
Italy
Contact:
Last name:
Site 0067
Facility:
Name:
Local Institution - 0097
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Contact:
Last name:
Site 0097
Facility:
Name:
Local Institution - 0099
Address:
City:
Arnhem
Zip:
6815 AD
Country:
Netherlands
Contact:
Last name:
Site 0099
Facility:
Name:
Local Institution - 0098
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Contact:
Last name:
Site 0098
Facility:
Name:
Local Institution - 0192
Address:
City:
Prabuty
Zip:
82-550
Country:
Poland
Contact:
Last name:
Site 0192
Facility:
Name:
Local Institution - 0193
Address:
City:
Konin
Zip:
62-500
Country:
Poland
Contact:
Last name:
Site 0193
Facility:
Name:
Local Institution - 0241
Address:
City:
Skorzewo
Zip:
60-185
Country:
Poland
Contact:
Last name:
Site 0241
Facility:
Name:
Local Institution - 0195
Address:
City:
Bydgoszcz
Zip:
85796
Country:
Poland
Contact:
Last name:
Site 0195
Facility:
Name:
Local Institution - 0189
Address:
City:
Łódź
Zip:
93-338
Country:
Poland
Contact:
Last name:
Site 0189
Facility:
Name:
Local Institution - 0135
Address:
City:
Bucuresti
Zip:
022328
Country:
Romania
Contact:
Last name:
Site 0135
Facility:
Name:
Local Institution - 0137
Address:
City:
Florești
Zip:
407280
Country:
Romania
Contact:
Last name:
Site 0137
Facility:
Name:
Local Institution - 0140
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Contact:
Last name:
Site 0140
Facility:
Name:
Local Institution - TEMP7289048470
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Facility:
Name:
Local Institution - 0133
Address:
City:
București
Zip:
022548
Country:
Romania
Contact:
Last name:
Site 0133
Facility:
Name:
Local Institution - 0141
Address:
City:
Cluj
Zip:
400015
Country:
Romania
Contact:
Last name:
Site 0141
Facility:
Name:
Local Institution - 0139
Address:
City:
Iași
Zip:
700106
Country:
Romania
Contact:
Last name:
Site 0139
Facility:
Name:
Local Institution - 0132
Address:
City:
Iași
Zip:
700483
Country:
Romania
Contact:
Last name:
Site 0132
Facility:
Name:
Local Institution - 0294
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Contact:
Last name:
Site 0294
Facility:
Name:
Local Institution - 0302
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Contact:
Last name:
Site 0302
Facility:
Name:
Local Institution - 0301
Address:
City:
Jaen
Zip:
23007
Country:
Spain
Contact:
Last name:
Site 0301
Facility:
Name:
Local Institution - 0296
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Contact:
Last name:
Site 0296
Facility:
Name:
Local Institution - 0248
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Contact:
Last name:
Site 0248
Facility:
Name:
Local Institution - 0249
Address:
City:
Winterthur
Zip:
8401
Country:
Switzerland
Contact:
Last name:
Site 0249
Facility:
Name:
Local Institution - 0247
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Contact:
Last name:
Site 0247
Facility:
Name:
Local Institution - 0158
Address:
City:
Cigli
Zip:
35620
Country:
Turkey
Contact:
Last name:
Site 0158
Facility:
Name:
Local Institution - 0154
Address:
City:
Adana
Zip:
01370
Country:
Turkey
Contact:
Last name:
Site 0154
Facility:
Name:
Local Institution - 0157
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Contact:
Last name:
Site 0157
Facility:
Name:
Local Institution - 0177
Address:
City:
Ankara
Zip:
06280
Country:
Turkey
Contact:
Last name:
Site 0177
Facility:
Name:
Local Institution - 0153
Address:
City:
Istanbul
Zip:
34732
Country:
Turkey
Contact:
Last name:
Site 0153
Facility:
Name:
Local Institution - 0197
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Contact:
Last name:
Site 0197
Facility:
Name:
Local Institution - 0183
Address:
City:
Central Middlesbrough
Zip:
TS4 3BW
Country:
United Kingdom
Contact:
Last name:
Site 0183
Facility:
Name:
Local Institution - 0159
Address:
City:
Aberdeen
Zip:
AB9 2ZB
Country:
United Kingdom
Contact:
Last name:
Site 0159
Facility:
Name:
Local Institution - 0108
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Contact:
Last name:
Site 0108
Facility:
Name:
Local Institution - 0101
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Contact:
Last name:
Site 0101
Start date:
January 21, 2025
Completion date:
September 5, 2031
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06646276
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/home
