NCT06561386ClinicalTrials.gov
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%
En resumen
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%
Fase 31000 participantes buscados326 centros31 países
Categorías
Registrado en 1 registro
- ClinicalTrials.govNCT06561386Abrir este registro en ClinicalTrials.govSincronizado hace 5 días
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2024-08-20; recorded start 2024-10-07
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 321 other studies in this databaseCounted from the lead sponsor named in the record (Bristol-Myers Squibb)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding0/20
Open-label
- Control arm15/15
Active-comparator control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
- Multi-centre8/8
Multi-centre: 320 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study, international in scope: 1,000 participants (target), run at 326 sites, across 31 countries.
How this score is built
- Enrolment30/40
1,000 participants (target)
- Site count25/25
320 sites
- Country count15/15
31 countries
- Planned duration10/10
Planned over about 95 months
- Sponsor scale9/10
Bristol-Myers Squibb has led 310 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
Resumen
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%
Afecciones
- Non-small Cell Lung Cancer
Elegibilidad
| Sexo | Todos |
|---|---|
| Edades | 18 Years – Sin máximo |
| Voluntarios sanos | No |
Elegibilidad tal como figura en el registro
Elegibilidad en frases sencillas
Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.
Diseño del estudio
| Tipo de estudio | De intervención |
|---|---|
| Fase | Fase 3 |
| Asignación | Aleatorizado |
| Modelo de intervención | PARALLEL |
| Propósito principal | TREATMENT |
| Enmascaramiento | NONE (0) |
| Inscripción | 1000 participantes buscados |
Patrocinador y colaboradores
- Bristol-Myers Squibb Patrocinador
Grupos e intervenciones
- Arm AEXPERIMENTAL
- Arm BACTIVE_COMPARATOR
Intervenciones
- Fármaco Carboplatin
Specified dose on specified days
- Fármaco Cisplatin
Specified dose on specified days
- Fármaco Nivolumab
Specified dose on specified days
- Fármaco Pembrolizumab
Specified dose on specified days
- Fármaco Pemetrexed
Specified dose on specified days
- Fármaco Relatlimab
Specified dose on specified days
Variables de resultado
Variable de resultado principal
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Plazo Up to 5 years
Variable de resultado secundaria
OS in randomized participants with PD-L1 ≥ 1%
Plazo Up to 5 years
Variable de resultado secundaria
Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Plazo Up to 5 years
Variable de resultado secundaria
Overall response rate (ORR)
Plazo Up to 5 years
Variable de resultado secundaria
Duration of response (DoR)
Plazo Up to 5 years
Variable de resultado secundaria
Number of participants with adverse events (AEs)
Plazo Up to 2.5 years
Variable de resultado secundaria
Number of participants with serious adverse events (SAEs)
Plazo Up to 2.5 years
Variable de resultado secundaria
Number of participants with immune-mediated adverse events (IMAEs)
Plazo Up to 2.5 years
Variable de resultado secundaria
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
Plazo Up to 2 years
Fechas
| Fecha de inicio | 7 de octubre de 2024 (real) |
|---|---|
| Finalización principal | 30 de julio de 2030 (estimada) |
| Finalización | 4 de agosto de 2032 (estimada) |
| Primera publicación | 20 de agosto de 2024 (real) |
| Última actualización | 14 de septiembre de 2026 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | septiembre de 2026 |
Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.
Ubicaciones
231 centros están en reclutamiento
Argentina
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Hospital Italiano de Buenos Aires | ABB | Buenos Aires F.D. | En reclutamiento |
| Local Institution - 0493 | Bariloche | Río Negro Province | Aún no recluta |
| Hospital Británico de Buenos Aires | Ciudad Autónoma de Buenos Aires | Buenos Aires | En reclutamiento |
| Instituto Alexander Fleming | Ciudad Autónoma de Buenos Aires | Buenos Aires | En reclutamiento |
| Hospital Privado Universitario de Córdoba | Córdoba | En reclutamiento | |
| Instituto Oncológico de Córdoba | Córdoba | En reclutamiento | |
| Hospital Privado de Comunidad | Mar del Plata | En reclutamiento | |
| Sanatorio Parque | Rosario | Santa Fe Province | En reclutamiento |
| Instituto Médico Río Cuarto | Río Cuarto | Córdoba Province | En reclutamiento |
Australia
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Box Hill Hospital | Box Hill | Victoria | En reclutamiento |
| The Prince Charles Hospital | Brisbane | Queensland | En reclutamiento |
| Gallipoli Medical Research Ltd | Brisbane | Queensland | En reclutamiento |
| Local Institution - 0057 | Elizabeth Vale | South Australia | Aún no recluta |
| Gosford Hospital | Gosford | New South Wales | En reclutamiento |
| Fiona Stanley Hospital | Murdoch | Western Australia | En reclutamiento |
| St. John of God Murdoch Hospital | Murdoch | Western Australia | En reclutamiento |
| GenesisCare North Shore | St Leonards | New South Wales | En reclutamiento |
Austria
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Universitätsklinikum Krems | Krems | Lower Austria | En reclutamiento |
| Klinik Floridsdorf | Vienna | En reclutamiento | |
| Klinikum Wels-Grieskirchen GmbH | Wels | Upper Austria | En reclutamiento |
Belgium
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| UZ Brussel | Brussels | Bruxelles-Capitale, Région de | En reclutamiento |
| Antwerp University Hospital | Edegem | Antwerpen | En reclutamiento |
| Jessa Ziekenhuis | Hasselt | Limburg | En reclutamiento |
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Liège | En reclutamiento | |
| AZ Delta vzw | Roeselare | West-Vlaanderen | En reclutamiento |
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne | Yvoir | Namur | En reclutamiento |
Brazil
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | En reclutamiento |
| NAIC - Instituto do Câncer | Bauru | São Paulo | En reclutamiento |
| Cetus Oncologia - Unidade Belo Horizonte | Belo Horizonte | Minas Gerais | En reclutamiento |
| CTO - Centro de Tratamento Oncológico | Belém | Pará | En reclutamiento |
| Pronutrir | Fortaleza | Ceará | En reclutamiento |
| Clínica de Neoplasias Litoral | Itajaí | Santa Catarina | En reclutamiento |
| Liga Norte Riograndense Contra o Câncer | Natal | Rio Grande do Norte | En reclutamiento |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | En reclutamiento |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | En reclutamiento |
| Instituto Nacional de Câncer - INCA | Rio de Janeiro | En reclutamiento | |
| Centro de Oncologia - CEON+ - Unidade São Caetano do Sul | São Caetano do Sul | São Paulo | En reclutamiento |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | En reclutamiento | |
| Local Institution - 0496 | São Paulo | Aún no recluta | |
| Local Institution - 0497 | Taubaté | São Paulo | Aún no recluta |
| Local Institution - 0501 | Timbó | Santa Catarina | Aún no recluta |
Canada
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0494 | Montreal | Quebec | Aún no recluta |
Chile
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0495 | Santiago | Vitacura | Aún no recluta |
| Orlandi Oncologia | Santiago | Santiago Metropolitan | En reclutamiento |
| Fundacion Arturo Lopez Perez (FALP) | Santiago | Santiago Metropolitan | En reclutamiento |
| Pontificia Universidad Catolica de Chile | Santiago | Santiago Metropolitan | En reclutamiento |
| Bradfordhill | Santiago | Santiago Metropolitan | En reclutamiento |
| Oncocentro Apys | Viña del Mar | Valparaiso | En reclutamiento |
China
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Beijing Cancer hospital | Beijing | Beijing Municipality | En reclutamiento |
| Hunan Cancer Hospital | Changsha | Hunan | En reclutamiento |
En el registro figuran 276 centros más.
Documentos del estudio
No hay documentos enlazados en este registro.
Cambios a lo largo del tiempo
- 14 de septiembre de 2026
Centro añadido
4 sites added (326 total)
322326
- 17 de agosto de 2026
Centro añadido
2 sites added (322 total)
320322