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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%

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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%

Phase 31 000 participants recherchés326 sites31 pays

Catégories

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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%

Affections

  • Non-small Cell Lung Cancer

Éligibilité

Éligibilité
SexeTous
Âges18 YearsAucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuNONE (0)
Recrutement1 000 participants recherchés

Promoteur et collaborateurs

  • Bristol-Myers Squibb Promoteur

Groupes et interventions

  • Arm AEXPERIMENTAL
  • Arm BACTIVE_COMPARATOR

Interventions

  • Médicament Carboplatin

    Specified dose on specified days

  • Médicament Cisplatin

    Specified dose on specified days

  • Médicament Nivolumab

    Specified dose on specified days

  • Médicament Pembrolizumab

    Specified dose on specified days

  • Médicament Pemetrexed

    Specified dose on specified days

  • Médicament Relatlimab

    Specified dose on specified days

Critères de jugement

  1. Critère de jugement principal

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

    Délai Up to 5 years

  2. Critère de jugement secondaire

    OS in randomized participants with PD-L1 ≥ 1%

    Délai Up to 5 years

  3. Critère de jugement secondaire

    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)

    Délai Up to 5 years

  4. Critère de jugement secondaire

    Overall response rate (ORR)

    Délai Up to 5 years

  5. Critère de jugement secondaire

    Duration of response (DoR)

    Délai Up to 5 years

  6. Critère de jugement secondaire

    Number of participants with adverse events (AEs)

    Délai Up to 2.5 years

  7. Critère de jugement secondaire

    Number of participants with serious adverse events (SAEs)

    Délai Up to 2.5 years

  8. Critère de jugement secondaire

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

    Délai Up to 2.5 years

  9. Critère de jugement secondaire

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

    Délai Up to 2 years

Dates

Dates
Date de début7 octobre 2024 (réelle)
Achèvement principal30 juillet 2030 (estimée)
Achèvement4 août 2032 (estimée)
Première publication20 août 2024 (réelle)
Dernière mise à jour14 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

231 sites sont en recrutement

Argentina

Argentina
ÉtablissementVilleÉtat ou régionStatut
Hospital Italiano de Buenos AiresABBBuenos Aires F.D.En recrutement
Local Institution - 0493BarilocheRío Negro ProvincePas encore en recrutement
Hospital Británico de Buenos AiresCiudad Autónoma de Buenos AiresBuenos AiresEn recrutement
Instituto Alexander FlemingCiudad Autónoma de Buenos AiresBuenos AiresEn recrutement
Hospital Privado Universitario de CórdobaCórdobaEn recrutement
Instituto Oncológico de CórdobaCórdobaEn recrutement
Hospital Privado de ComunidadMar del PlataEn recrutement
Sanatorio ParqueRosarioSanta Fe ProvinceEn recrutement
Instituto Médico Río CuartoRío CuartoCórdoba ProvinceEn recrutement

Australia

Australia
ÉtablissementVilleÉtat ou régionStatut
Box Hill HospitalBox HillVictoriaEn recrutement
The Prince Charles HospitalBrisbaneQueenslandEn recrutement
Gallipoli Medical Research LtdBrisbaneQueenslandEn recrutement
Local Institution - 0057Elizabeth ValeSouth AustraliaPas encore en recrutement
Gosford HospitalGosfordNew South WalesEn recrutement
Fiona Stanley HospitalMurdochWestern AustraliaEn recrutement
St. John of God Murdoch HospitalMurdochWestern AustraliaEn recrutement
GenesisCare North ShoreSt LeonardsNew South WalesEn recrutement

Austria

Austria
ÉtablissementVilleÉtat ou régionStatut
Universitätsklinikum KremsKremsLower AustriaEn recrutement
Klinik FloridsdorfViennaEn recrutement
Klinikum Wels-Grieskirchen GmbHWelsUpper AustriaEn recrutement

Belgium

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

Brazil

Brazil
ÉtablissementVilleÉtat ou régionStatut
Fundação Pio XII - Hospital de Câncer de BarretosBarretosSão PauloEn recrutement
NAIC - Instituto do CâncerBauruSão PauloEn recrutement
Cetus Oncologia - Unidade Belo HorizonteBelo HorizonteMinas GeraisEn recrutement
CTO - Centro de Tratamento OncológicoBelémParáEn recrutement
PronutrirFortalezaCearáEn recrutement
Clínica de Neoplasias LitoralItajaíSanta CatarinaEn recrutement
Liga Norte Riograndense Contra o CâncerNatalRio Grande do NorteEn recrutement
Hospital São Lucas da PUCRSPorto AlegreRio Grande do SulEn recrutement
Hospital de Clinicas de Porto AlegrePorto AlegreRio Grande do SulEn recrutement
Instituto Nacional de Câncer - INCARio de JaneiroEn recrutement
Centro de Oncologia - CEON+ - Unidade São Caetano do SulSão Caetano do SulSão PauloEn recrutement
Icesp - Instituto Do Câncer Do Estado de São PauloSão PauloEn recrutement
Local Institution - 0496São PauloPas encore en recrutement
Local Institution - 0497TaubatéSão PauloPas encore en recrutement
Local Institution - 0501TimbóSanta CatarinaPas encore en recrutement

Canada

Canada
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0494MontrealQuebecPas encore en recrutement

Chile

Chile
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0495SantiagoVitacuraPas encore en recrutement
Orlandi OncologiaSantiagoSantiago MetropolitanEn recrutement
Fundacion Arturo Lopez Perez (FALP)SantiagoSantiago MetropolitanEn recrutement
Pontificia Universidad Catolica de ChileSantiagoSantiago MetropolitanEn recrutement
BradfordhillSantiagoSantiago MetropolitanEn recrutement
Oncocentro ApysViña del MarValparaisoEn recrutement

China

China
ÉtablissementVilleÉtat ou régionStatut
Beijing Cancer hospitalBeijingBeijing MunicipalityEn recrutement
Hunan Cancer HospitalChangshaHunanEn recrutement

276 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 14 septembre 2026

    Site ajouté

    4 sites added (326 total)

    322326

  2. 17 août 2026

    Site ajouté

    2 sites added (322 total)

    320322