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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06646276




Registration number
NCT06646276
Ethics application status
Date submitted
16/10/2024
Date registered
17/10/2024

Titles & IDs
Public 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).
Scientific title
A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
Secondary ID [1] 0 0
CA245-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive-Stage Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BMS-986489 (BMS-986012+Nivolumab)
Treatment: Other - Atezolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide

Experimental: Arm A -

Active comparator: Arm B -


Treatment: Other: BMS-986489 (BMS-986012+Nivolumab)
Specified dose on specified days

Treatment: Other: Atezolizumab
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Etoposide
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to 135 days after last treatment
Secondary outcome [3] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to 135 days after last treatment
Secondary outcome [4] 0 0
Number of Participants with Adverse Events (AEs) leading to discontinuation and death
Timepoint [4] 0 0
Up to 135 days after last treatment
Secondary outcome [5] 0 0
Objective Response (OR)
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Progression Free Survival (PFS)
Timepoint [7] 0 0
Up to 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
21/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/09/2031
Actual
Sample size
Target
530
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0202 - Campbelltown
Recruitment hospital [2] 0 0
Local Institution - 0106 - Penrith
Recruitment hospital [3] 0 0
Local Institution - 0105 - Brisbane
Recruitment hospital [4] 0 0
Local Institution - 0190 - Ballarat Central
Recruitment hospital [5] 0 0
Local Institution - 0175 - Murdoch
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2750 - Penrith
Recruitment postcode(s) [3] 0 0
4120 - Brisbane
Recruitment postcode(s) [4] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
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United States of America
State/province [3] 0 0
Minnesota
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United States of America
State/province [4] 0 0
New Mexico
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United States of America
State/province [5] 0 0
North Carolina
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United States of America
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Ohio
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
State/province [9] 0 0
Texas
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United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad Autónoma De Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Córdoba
Country [15] 0 0
Austria
State/province [15] 0 0
Oberösterreich
Country [16] 0 0
Austria
State/province [16] 0 0
Steiermark
Country [17] 0 0
Austria
State/province [17] 0 0
Linz
Country [18] 0 0
Austria
State/province [18] 0 0
Rankweil
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Belgium
State/province [20] 0 0
Oost-Vlaanderen
Country [21] 0 0
Belgium
State/province [21] 0 0
Vlaams-Brabant
Country [22] 0 0
Belgium
State/province [22] 0 0
Liège
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Brazil
State/province [23] 0 0
Ceará
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Brazil
State/province [24] 0 0
Rio Grande Do Sul
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Brazil
State/province [25] 0 0
Santa Catarina
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Brazil
State/province [26] 0 0
São Paulo
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Canada
State/province [27] 0 0
Alberta
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Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Chile
State/province [29] 0 0
Región Metropolitana De Santiago
Country [30] 0 0
Chile
State/province [30] 0 0
Valparaíso
Country [31] 0 0
Czechia
State/province [31] 0 0
Brno-mesto
Country [32] 0 0
Czechia
State/province [32] 0 0
Ostrava Mesto
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 4
Country [34] 0 0
Czechia
State/province [34] 0 0
Olomouc
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France
State/province [35] 0 0
Hérault
Country [36] 0 0
France
State/province [36] 0 0
Isère
Country [37] 0 0
France
State/province [37] 0 0
Nord-Pas-de-Calais
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France
State/province [38] 0 0
Rhône
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France
State/province [39] 0 0
Val-de-Marne
Country [40] 0 0
France
State/province [40] 0 0
Marseille
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France
State/province [41] 0 0
Paris
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France
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Quimper
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Germany
State/province [43] 0 0
Hessen
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Germany
State/province [44] 0 0
Niedersachsen
Country [45] 0 0
Germany
State/province [45] 0 0
Nordrhein-Westfalen
Country [46] 0 0
Germany
State/province [46] 0 0
Sachsen-Anhalt
Country [47] 0 0
Germany
State/province [47] 0 0
Thüringen
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Gauting
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Germany
State/province [50] 0 0
Grosshansdorf
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Germany
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Stuttgart
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Greece
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Attikí
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Greece
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Kentrikí Makedonía
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Greece
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Thessaloníki
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Greece
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Thessalía
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India
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Delhi
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India
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Karnataka
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India
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Tamil Nadu
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India
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Uttar Pradesh
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India
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West Bengal
Country [61] 0 0
Italy
State/province [61] 0 0
Campania
Country [62] 0 0
Italy
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Lombardia
Country [63] 0 0
Italy
State/province [63] 0 0
Roma
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Italy
State/province [64] 0 0
Umbria
Country [65] 0 0
Italy
State/province [65] 0 0
Verona
Country [66] 0 0
Italy
State/province [66] 0 0
Bologna
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Italy
State/province [67] 0 0
Milano
Country [68] 0 0
Netherlands
State/province [68] 0 0
Noord-Holland
Country [69] 0 0
Netherlands
State/province [69] 0 0
Arnhem
Country [70] 0 0
Netherlands
State/province [70] 0 0
Groningen
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Poland
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Pomorskie
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Poland
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Wielkopolskie
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Poland
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Bydgoszcz
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Poland
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Lódzkie
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Romania
State/province [75] 0 0
Bucure?ti
Country [76] 0 0
Romania
State/province [76] 0 0
Cluj
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Romania
State/province [77] 0 0
Dolj
Country [78] 0 0
Romania
State/province [78] 0 0
Ia?i
Country [79] 0 0
Spain
State/province [79] 0 0
Catalunya [Cataluña]
Country [80] 0 0
Spain
State/province [80] 0 0
Jaén
Country [81] 0 0
Spain
State/province [81] 0 0
Madrid, Comunidad De
Country [82] 0 0
Switzerland
State/province [82] 0 0
Chur
Country [83] 0 0
Switzerland
State/province [83] 0 0
Winterthur
Country [84] 0 0
Switzerland
State/province [84] 0 0
Zürich
Country [85] 0 0
Turkey
State/province [85] 0 0
Izmir
Country [86] 0 0
Turkey
State/province [86] 0 0
Adana
Country [87] 0 0
Turkey
State/province [87] 0 0
Ankara
Country [88] 0 0
Turkey
State/province [88] 0 0
Istanbul
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London, City Of
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Middlesbrough
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Aberdeen
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Leicester
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicaltrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@BMS.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol-Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06646276