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).

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06646276Tipo: INTERVENTIONALInicio: 25 de feb de 2025Fin estimado: 5 de sept de 2031

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Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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

Ubicaciones

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Diego Enrico, Site 0079 · +5491132218900

RECRUITING

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Yamila Ferreira, Site 0077 · 11-49590200ext8159

RECRUITING

Local Institution - 0100

Buenos Aires, Buenos Aires F.D., Argentina

WITHDRAWN

Clinica Adventista Belgrano

CABA, Buenos Aires F.D., Argentina

Aldo Perfetti, Site 0080 · 5491132682903

RECRUITING

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Saul Del Grecco, Site 0094 · 03512446211

RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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