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).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986489 (BMS-986012+Nivolumab), Atezolizumab, Carboplatin, Etoposide.
- Who it may be relevant to
- Registry conditions: Extensive-Stage Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +21
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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).
Overview
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.
Interventions
- Biological BMS-986489 (BMS-986012+Nivolumab)
Specified dose on specified days - Biological Atezolizumab
Specified dose on specified days - Drug Carboplatin
Specified dose on specified days - Drug Etoposide
Specified dose on specified days
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to 5 years]
Secondary outcome measures (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). [Time frame: Up to 5 years]
- Number of participants with Adverse Events (AEs) [Time frame: Up to 135 days after last treatment]
- Number of Participants with Serious Adverse Events (SAEs) [Time frame: Up to 135 days after last treatment]
- Number of Participants with Adverse Events (AEs) leading to discontinuation and death [Time frame: Up to 135 days after last treatment]
- Objective Response (OR) [Time frame: Up to 5 years]
- Duration of Response (DOR) [Time frame: Up to 5 years]
- Progression Free Survival (PFS) [Time frame: Up to 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 23 centers
- Local Institution - 0204 — Beijing
- Local Institution - 0336 — Beijing
- Local Institution - 0203 — Chongqing
- Local Institution - 0308 — Fuzhou
- Local Institution - 0212 — Xiamen
- Local Institution - 0234 — Shantou
- Local Institution - 0227 — Harbin
- Local Institution - 0209 — Wuhan
- … and 15 more centers
United States · 20 centers
- Southern Cancer Center, PC — Daphne
- Local Institution - 0283 — Hot Springs
- Florida Cancer Specialists - South — Fort Myers
- Mid Florida Hematology and Oncology Center — Orange City
- Florida Cancer Specialists - North — St. Petersburg
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Marietta
- Illinois Cancer Care — Peoria
- Local Institution - 0037 — Minneapolis
- … and 12 more centers
Japan · 18 centers
Center list to be confirmed — check the primary protocol.
France · 10 centers
Center list to be confirmed — check the primary protocol.
Spain · 10 centers
Center list to be confirmed — check the primary protocol.
Germany · 9 centers
Center list to be confirmed — check the primary protocol.
Brazil · 7 centers
- Local Institution - 0166 — Fortaleza
- Local Institution - 0165 — Porto Alegre
- Local Institution - 0169 — Porto Alegre
- Local Institution - 0170 — Santa Cruz do Sul
- Local Institution - 0163 — Itajaí
- Local Institution - 0178 — Barretos
- Local Institution - 0111 — São Paulo
Italy · 7 centers
Center list to be confirmed — check the primary protocol.
Romania · 7 centers
Center list to be confirmed — check the primary protocol.
South Korea · 6 centers
Center list to be confirmed — check the primary protocol.
Argentina · 5 centers
- Local Institution - 0079 — Ciudad Autónoma de Buenos Aires
- Local Institution - 0077 — ABB
- Local Institution - 0100 — Buenos Aires
- Local Institution - 0080 — CABA
- Local Institution - 0094 — Río Cuarto
Australia · 5 centers
- Local Institution - 0202 — Campbelltown
- Local Institution - 0106 — Penrith
- Local Institution - 0105 — Brisbane
- Local Institution - 0190 — Ballarat Central
- Local Institution - 0175 — Murdoch
Chile · 5 centers
- Local Institution - 0086 — Santiago
- Local Institution - 0085 — Santiago
- Local Institution - 0083 — Santiago
- Local Institution - 0084 — Santiago
- Local Institution - 0082 — Viña del Mar
Greece · 5 centers
Center list to be confirmed — check the primary protocol.
India · 5 centers
Center list to be confirmed — check the primary protocol.
Poland · 5 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 5 centers
Center list to be confirmed — check the primary protocol.
Austria · 4 centers
- Local Institution - 0253 — Graz
- Local Institution - 0251 — Wels
- Local Institution - 0252 — Linz
- Local Institution - 0255 — Rankweil
Belgium · 4 centers
- Local Institution - 0198 — Brussels
- Local Institution - 0091 — Ghent
- Local Institution - 0187 — Sint-Niklaas
- Local Institution - 0092 — Liège
Canada · 4 centers
- Local Institution - 0289 — Edmonton
- Local Institution - 0290 — Chicoutimi
- Local Institution - 0288 — Québec
- Local Institution - 0287 — Rimouski
Czechia · 4 centers
- Local Institution - 0114 — Brno
- Local Institution - 0117 — Ostrava
- Local Institution - 0113 — Prague
- … and 1 more center
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Malaysia · 3 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 3 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 3 centers
Center list to be confirmed — check the primary protocol.
Mexico · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06646276 · CA245-0001