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xMedica

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%

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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%

שלב 3דרושים 1,000 משתתפים326 אתרים31 מדינות

קטגוריות

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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%

מצבים רפואיים

  • Non-small Cell Lung Cancer

זכאות

זכאות
מיןהכול
גילאים18 Yearsללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 1,000 משתתפים

נותן חסות ושותפים

  • Bristol-Myers Squibb נותן חסות

זרועות והתערבויות

  • Arm AEXPERIMENTAL
  • Arm BACTIVE_COMPARATOR

התערבויות

  • תרופה Carboplatin

    Specified dose on specified days

  • תרופה Cisplatin

    Specified dose on specified days

  • תרופה Nivolumab

    Specified dose on specified days

  • תרופה Pembrolizumab

    Specified dose on specified days

  • תרופה Pemetrexed

    Specified dose on specified days

  • תרופה Relatlimab

    Specified dose on specified days

מדדי תוצאה

  1. מדד תוצאה ראשוני

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

    מסגרת זמן Up to 5 years

  2. מדד תוצאה משני

    OS in randomized participants with PD-L1 ≥ 1%

    מסגרת זמן Up to 5 years

  3. מדד תוצאה משני

    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)

    מסגרת זמן Up to 5 years

  4. מדד תוצאה משני

    Overall response rate (ORR)

    מסגרת זמן Up to 5 years

  5. מדד תוצאה משני

    Duration of response (DoR)

    מסגרת זמן Up to 5 years

  6. מדד תוצאה משני

    Number of participants with adverse events (AEs)

    מסגרת זמן Up to 2.5 years

  7. מדד תוצאה משני

    Number of participants with serious adverse events (SAEs)

    מסגרת זמן Up to 2.5 years

  8. מדד תוצאה משני

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

    מסגרת זמן Up to 2.5 years

  9. מדד תוצאה משני

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

    מסגרת זמן Up to 2 years

תאריכים

תאריכים
תאריך התחלה7 באוקטובר 2024 (בפועל)
סיום ראשוני30 ביולי 2030 (משוער)
סיום4 באוגוסט 2032 (משוער)
פורסם לראשונה20 באוגוסט 2024 (בפועל)
עודכן לאחרונה14 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

231 אתרים מגייסים

Argentina

Argentina
מתקןעירמדינה או אזורמצב
Hospital Italiano de Buenos AiresABBBuenos Aires F.D.מגייס
Local Institution - 0493BarilocheRío Negro Provinceטרם מגייס
Hospital Británico de Buenos AiresCiudad Autónoma de Buenos AiresBuenos Airesמגייס
Instituto Alexander FlemingCiudad Autónoma de Buenos AiresBuenos Airesמגייס
Hospital Privado Universitario de CórdobaCórdobaמגייס
Instituto Oncológico de CórdobaCórdobaמגייס
Hospital Privado de ComunidadMar del Plataמגייס
Sanatorio ParqueRosarioSanta Fe Provinceמגייס
Instituto Médico Río CuartoRío CuartoCórdoba Provinceמגייס

Australia

Australia
מתקןעירמדינה או אזורמצב
Box Hill HospitalBox HillVictoriaמגייס
The Prince Charles HospitalBrisbaneQueenslandמגייס
Gallipoli Medical Research LtdBrisbaneQueenslandמגייס
Local Institution - 0057Elizabeth ValeSouth Australiaטרם מגייס
Gosford HospitalGosfordNew South Walesמגייס
Fiona Stanley HospitalMurdochWestern Australiaמגייס
St. John of God Murdoch HospitalMurdochWestern Australiaמגייס
GenesisCare North ShoreSt LeonardsNew South Walesמגייס

Austria

Austria
מתקןעירמדינה או אזורמצב
Universitätsklinikum KremsKremsLower Austriaמגייס
Klinik FloridsdorfViennaמגייס
Klinikum Wels-Grieskirchen GmbHWelsUpper Austriaמגייס

Belgium

Belgium
מתקןעירמדינה או אזורמצב
UZ BrusselBrusselsBruxelles-Capitale, Région deמגייס
Antwerp University HospitalEdegemAntwerpenמגייס
Jessa ZiekenhuisHasseltLimburgמגייס
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart TilmanLiègeמגייס
AZ Delta vzwRoeselareWest-Vlaanderenמגייס
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodinneYvoirNamurמגייס

Brazil

Brazil
מתקןעירמדינה או אזורמצב
Fundação Pio XII - Hospital de Câncer de BarretosBarretosSão Pauloמגייס
NAIC - Instituto do CâncerBauruSão Pauloמגייס
Cetus Oncologia - Unidade Belo HorizonteBelo HorizonteMinas Geraisמגייס
CTO - Centro de Tratamento OncológicoBelémParáמגייס
PronutrirFortalezaCearáמגייס
Clínica de Neoplasias LitoralItajaíSanta Catarinaמגייס
Liga Norte Riograndense Contra o CâncerNatalRio Grande do Norteמגייס
Hospital São Lucas da PUCRSPorto AlegreRio Grande do Sulמגייס
Hospital de Clinicas de Porto AlegrePorto AlegreRio Grande do Sulמגייס
Instituto Nacional de Câncer - INCARio de Janeiroמגייס
Centro de Oncologia - CEON+ - Unidade São Caetano do SulSão Caetano do SulSão Pauloמגייס
Icesp - Instituto Do Câncer Do Estado de São PauloSão Pauloמגייס
Local Institution - 0496São Pauloטרם מגייס
Local Institution - 0497TaubatéSão Pauloטרם מגייס
Local Institution - 0501TimbóSanta Catarinaטרם מגייס

Canada

Canada
מתקןעירמדינה או אזורמצב
Local Institution - 0494MontrealQuebecטרם מגייס

Chile

Chile
מתקןעירמדינה או אזורמצב
Local Institution - 0495SantiagoVitacuraטרם מגייס
Orlandi OncologiaSantiagoSantiago Metropolitanמגייס
Fundacion Arturo Lopez Perez (FALP)SantiagoSantiago Metropolitanמגייס
Pontificia Universidad Catolica de ChileSantiagoSantiago Metropolitanמגייס
BradfordhillSantiagoSantiago Metropolitanמגייס
Oncocentro ApysViña del MarValparaisoמגייס

China

China
מתקןעירמדינה או אזורמצב
Beijing Cancer hospitalBeijingBeijing Municipalityמגייס
Hunan Cancer HospitalChangshaHunanמגייס

276 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 14 בספטמבר 2026

    אתר נוסף

    4 sites added (326 total)

    322326

  2. 17 באוגוסט 2026

    אתר נוסף

    2 sites added (322 total)

    320322