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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%

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati326 centri31 paesi

Categorie

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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%

Patologie

  • Non-small Cell Lung Cancer

Idoneità

Idoneità
SessoTutti
Età18 YearsNessun massimo
Volontari saniNo

Idoneità come riportata nel 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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoNONE (0)
Arruolamento1000 partecipanti ricercati

Sponsor e collaboratori

  • Bristol-Myers Squibb Sponsor

Bracci e interventi

  • Arm AEXPERIMENTAL
  • Arm BACTIVE_COMPARATOR

Interventi

  • Farmaco Carboplatin

    Specified dose on specified days

  • Farmaco Cisplatin

    Specified dose on specified days

  • Farmaco Nivolumab

    Specified dose on specified days

  • Farmaco Pembrolizumab

    Specified dose on specified days

  • Farmaco Pemetrexed

    Specified dose on specified days

  • Farmaco Relatlimab

    Specified dose on specified days

Esiti misurati

  1. Esito primario

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

    Orizzonte temporale Up to 5 years

  2. Esito secondario

    OS in randomized participants with PD-L1 ≥ 1%

    Orizzonte temporale Up to 5 years

  3. Esito secondario

    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)

    Orizzonte temporale Up to 5 years

  4. Esito secondario

    Overall response rate (ORR)

    Orizzonte temporale Up to 5 years

  5. Esito secondario

    Duration of response (DoR)

    Orizzonte temporale Up to 5 years

  6. Esito secondario

    Number of participants with adverse events (AEs)

    Orizzonte temporale Up to 2.5 years

  7. Esito secondario

    Number of participants with serious adverse events (SAEs)

    Orizzonte temporale Up to 2.5 years

  8. Esito secondario

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

    Orizzonte temporale Up to 2.5 years

  9. Esito secondario

    The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score

    Orizzonte temporale Up to 2 years

Date

Date
Data di inizio7 ottobre 2024 (effettiva)
Conclusione primaria30 luglio 2030 (stimata)
Conclusione4 agosto 2032 (stimata)
Prima pubblicazione20 agosto 2024 (effettiva)
Ultimo aggiornamento14 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

231 centri stanno reclutando

Argentina

Argentina
StrutturaCittàStato o regioneStato
Hospital Italiano de Buenos AiresABBBuenos Aires F.D.In reclutamento
Local Institution - 0493BarilocheRío Negro ProvinceNon ancora in reclutamento
Hospital Británico de Buenos AiresCiudad Autónoma de Buenos AiresBuenos AiresIn reclutamento
Instituto Alexander FlemingCiudad Autónoma de Buenos AiresBuenos AiresIn reclutamento
Hospital Privado Universitario de CórdobaCórdobaIn reclutamento
Instituto Oncológico de CórdobaCórdobaIn reclutamento
Hospital Privado de ComunidadMar del PlataIn reclutamento
Sanatorio ParqueRosarioSanta Fe ProvinceIn reclutamento
Instituto Médico Río CuartoRío CuartoCórdoba ProvinceIn reclutamento

Australia

Australia
StrutturaCittàStato o regioneStato
Box Hill HospitalBox HillVictoriaIn reclutamento
The Prince Charles HospitalBrisbaneQueenslandIn reclutamento
Gallipoli Medical Research LtdBrisbaneQueenslandIn reclutamento
Local Institution - 0057Elizabeth ValeSouth AustraliaNon ancora in reclutamento
Gosford HospitalGosfordNew South WalesIn reclutamento
Fiona Stanley HospitalMurdochWestern AustraliaIn reclutamento
St. John of God Murdoch HospitalMurdochWestern AustraliaIn reclutamento
GenesisCare North ShoreSt LeonardsNew South WalesIn reclutamento

Austria

Austria
StrutturaCittàStato o regioneStato
Universitätsklinikum KremsKremsLower AustriaIn reclutamento
Klinik FloridsdorfViennaIn reclutamento
Klinikum Wels-Grieskirchen GmbHWelsUpper AustriaIn reclutamento

Belgium

Belgium
StrutturaCittàStato o regioneStato
UZ BrusselBrusselsBruxelles-Capitale, Région deIn reclutamento
Antwerp University HospitalEdegemAntwerpenIn reclutamento
Jessa ZiekenhuisHasseltLimburgIn reclutamento
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart TilmanLiègeIn reclutamento
AZ Delta vzwRoeselareWest-VlaanderenIn reclutamento
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodinneYvoirNamurIn reclutamento

Brazil

Brazil
StrutturaCittàStato o regioneStato
Fundação Pio XII - Hospital de Câncer de BarretosBarretosSão PauloIn reclutamento
NAIC - Instituto do CâncerBauruSão PauloIn reclutamento
Cetus Oncologia - Unidade Belo HorizonteBelo HorizonteMinas GeraisIn reclutamento
CTO - Centro de Tratamento OncológicoBelémParáIn reclutamento
PronutrirFortalezaCearáIn reclutamento
Clínica de Neoplasias LitoralItajaíSanta CatarinaIn reclutamento
Liga Norte Riograndense Contra o CâncerNatalRio Grande do NorteIn reclutamento
Hospital São Lucas da PUCRSPorto AlegreRio Grande do SulIn reclutamento
Hospital de Clinicas de Porto AlegrePorto AlegreRio Grande do SulIn reclutamento
Instituto Nacional de Câncer - INCARio de JaneiroIn reclutamento
Centro de Oncologia - CEON+ - Unidade São Caetano do SulSão Caetano do SulSão PauloIn reclutamento
Icesp - Instituto Do Câncer Do Estado de São PauloSão PauloIn reclutamento
Local Institution - 0496São PauloNon ancora in reclutamento
Local Institution - 0497TaubatéSão PauloNon ancora in reclutamento
Local Institution - 0501TimbóSanta CatarinaNon ancora in reclutamento

Canada

Canada
StrutturaCittàStato o regioneStato
Local Institution - 0494MontrealQuebecNon ancora in reclutamento

Chile

Chile
StrutturaCittàStato o regioneStato
Local Institution - 0495SantiagoVitacuraNon ancora in reclutamento
Orlandi OncologiaSantiagoSantiago MetropolitanIn reclutamento
Fundacion Arturo Lopez Perez (FALP)SantiagoSantiago MetropolitanIn reclutamento
Pontificia Universidad Catolica de ChileSantiagoSantiago MetropolitanIn reclutamento
BradfordhillSantiagoSantiago MetropolitanIn reclutamento
Oncocentro ApysViña del MarValparaisoIn reclutamento

China

China
StrutturaCittàStato o regioneStato
Beijing Cancer hospitalBeijingBeijing MunicipalityIn reclutamento
Hunan Cancer HospitalChangshaHunanIn reclutamento

Nella scheda del registro sono indicati altri 276 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 14 settembre 2026

    Centro aggiunto

    4 sites added (326 total)

    322326

  2. 17 agosto 2026

    Centro aggiunto

    2 sites added (322 total)

    320322