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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%

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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

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Methodological rigourSTRONG

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

ScaleLARGE

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

Investigator standingUNKNOWN

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

Elegibilidad
SexoTodos
Edades18 YearsSin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria * Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization. * Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. * Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. * Participants must have a life expectancy of at least 3 months at the time of randomization. Exclusion Criteria * Participants must not be pregnant and/or breastfeeding. * Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded. * Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible. * Participants must not have untreated central nervous system (CNS) metastases. * Participants must not have leptomeningeal metastases (carcinomatous meningitis). * Participants must not have concurrent malignancy requiring treatment. * Participants must not have an active autoimmune disease. * Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management. * Participants must not have a history of myocarditis. * Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. * Other protocol-defined Inclusion/Exclusion criteria apply.

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

Diseño del estudio
Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción1000 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

  1. Variable de resultado principal

    Overall survival (OS) in randomized participants with PD-L1 1% to 49%

    Plazo Up to 5 years

  2. Variable de resultado secundaria

    OS in randomized participants with PD-L1 ≥ 1%

    Plazo Up to 5 years

  3. 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

  4. Variable de resultado secundaria

    Overall response rate (ORR)

    Plazo Up to 5 years

  5. Variable de resultado secundaria

    Duration of response (DoR)

    Plazo Up to 5 years

  6. Variable de resultado secundaria

    Number of participants with adverse events (AEs)

    Plazo Up to 2.5 years

  7. Variable de resultado secundaria

    Number of participants with serious adverse events (SAEs)

    Plazo Up to 2.5 years

  8. Variable de resultado secundaria

    Number of participants with immune-mediated adverse events (IMAEs)

    Plazo Up to 2.5 years

  9. 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

Fechas
Fecha de inicio7 de octubre de 2024 (real)
Finalización principal30 de julio de 2030 (estimada)
Finalización4 de agosto de 2032 (estimada)
Primera publicación20 de agosto de 2024 (real)
Última actualización14 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre 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

Argentina
CentroCiudadEstado o regiónEstado
Hospital Italiano de Buenos AiresABBBuenos Aires F.D.En reclutamiento
Local Institution - 0493BarilocheRío Negro ProvinceAún no recluta
Hospital Británico de Buenos AiresCiudad Autónoma de Buenos AiresBuenos AiresEn reclutamiento
Instituto Alexander FlemingCiudad Autónoma de Buenos AiresBuenos AiresEn reclutamiento
Hospital Privado Universitario de CórdobaCórdobaEn reclutamiento
Instituto Oncológico de CórdobaCórdobaEn reclutamiento
Hospital Privado de ComunidadMar del PlataEn reclutamiento
Sanatorio ParqueRosarioSanta Fe ProvinceEn reclutamiento
Instituto Médico Río CuartoRío CuartoCórdoba ProvinceEn reclutamiento

Australia

Australia
CentroCiudadEstado o regiónEstado
Box Hill HospitalBox HillVictoriaEn reclutamiento
The Prince Charles HospitalBrisbaneQueenslandEn reclutamiento
Gallipoli Medical Research LtdBrisbaneQueenslandEn reclutamiento
Local Institution - 0057Elizabeth ValeSouth AustraliaAún no recluta
Gosford HospitalGosfordNew South WalesEn reclutamiento
Fiona Stanley HospitalMurdochWestern AustraliaEn reclutamiento
St. John of God Murdoch HospitalMurdochWestern AustraliaEn reclutamiento
GenesisCare North ShoreSt LeonardsNew South WalesEn reclutamiento

Austria

Austria
CentroCiudadEstado o regiónEstado
Universitätsklinikum KremsKremsLower AustriaEn reclutamiento
Klinik FloridsdorfViennaEn reclutamiento
Klinikum Wels-Grieskirchen GmbHWelsUpper AustriaEn reclutamiento

Belgium

Belgium
CentroCiudadEstado o regiónEstado
UZ BrusselBrusselsBruxelles-Capitale, Région deEn reclutamiento
Antwerp University HospitalEdegemAntwerpenEn reclutamiento
Jessa ZiekenhuisHasseltLimburgEn reclutamiento
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart TilmanLiègeEn reclutamiento
AZ Delta vzwRoeselareWest-VlaanderenEn reclutamiento
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodinneYvoirNamurEn reclutamiento

Brazil

Brazil
CentroCiudadEstado o regiónEstado
Fundação Pio XII - Hospital de Câncer de BarretosBarretosSão PauloEn reclutamiento
NAIC - Instituto do CâncerBauruSão PauloEn reclutamiento
Cetus Oncologia - Unidade Belo HorizonteBelo HorizonteMinas GeraisEn reclutamiento
CTO - Centro de Tratamento OncológicoBelémParáEn reclutamiento
PronutrirFortalezaCearáEn reclutamiento
Clínica de Neoplasias LitoralItajaíSanta CatarinaEn reclutamiento
Liga Norte Riograndense Contra o CâncerNatalRio Grande do NorteEn reclutamiento
Hospital São Lucas da PUCRSPorto AlegreRio Grande do SulEn reclutamiento
Hospital de Clinicas de Porto AlegrePorto AlegreRio Grande do SulEn reclutamiento
Instituto Nacional de Câncer - INCARio de JaneiroEn reclutamiento
Centro de Oncologia - CEON+ - Unidade São Caetano do SulSão Caetano do SulSão PauloEn reclutamiento
Icesp - Instituto Do Câncer Do Estado de São PauloSão PauloEn reclutamiento
Local Institution - 0496São PauloAún no recluta
Local Institution - 0497TaubatéSão PauloAún no recluta
Local Institution - 0501TimbóSanta CatarinaAún no recluta

Canada

Canada
CentroCiudadEstado o regiónEstado
Local Institution - 0494MontrealQuebecAún no recluta

Chile

Chile
CentroCiudadEstado o regiónEstado
Local Institution - 0495SantiagoVitacuraAún no recluta
Orlandi OncologiaSantiagoSantiago MetropolitanEn reclutamiento
Fundacion Arturo Lopez Perez (FALP)SantiagoSantiago MetropolitanEn reclutamiento
Pontificia Universidad Catolica de ChileSantiagoSantiago MetropolitanEn reclutamiento
BradfordhillSantiagoSantiago MetropolitanEn reclutamiento
Oncocentro ApysViña del MarValparaisoEn reclutamiento

China

China
CentroCiudadEstado o regiónEstado
Beijing Cancer hospitalBeijingBeijing MunicipalityEn reclutamiento
Hunan Cancer HospitalChangshaHunanEn reclutamiento

En el registro figuran 276 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 14 de septiembre de 2026

    Centro añadido

    4 sites added (326 total)

    322326

  2. 17 de agosto de 2026

    Centro añadido

    2 sites added (322 total)

    320322