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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%

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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%

المرحلة 3مطلوب 1,000 مشارك326 موقعاً31 دولة

الفئات

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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%

الحالات

  • Non-small Cell Lung Cancer

الأهلية

الأهلية
الجنسالجميع
الأعمار18 Yearsلا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 1,000 مشارك

الجهة الراعية والمتعاونون

  • Bristol-Myers Squibb الجهة الراعية

الأذرع والتدخلات

  • Arm AEXPERIMENTAL
  • Arm BACTIVE_COMPARATOR

التدخلات

  • دواء Carboplatin

    Specified dose on specified days

  • دواء Cisplatin

    Specified dose on specified days

  • دواء Nivolumab

    Specified dose on specified days

  • دواء Pembrolizumab

    Specified dose on specified days

  • دواء Pemetrexed

    Specified dose on specified days

  • دواء Relatlimab

    Specified dose on specified days

مقاييس النتائج

  1. مقياس النتيجة الأولي

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

    الإطار الزمني Up to 5 years

  2. مقياس النتيجة الثانوي

    OS in randomized participants with PD-L1 ≥ 1%

    الإطار الزمني Up to 5 years

  3. مقياس النتيجة الثانوي

    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)

    الإطار الزمني Up to 5 years

  4. مقياس النتيجة الثانوي

    Overall response rate (ORR)

    الإطار الزمني Up to 5 years

  5. مقياس النتيجة الثانوي

    Duration of response (DoR)

    الإطار الزمني Up to 5 years

  6. مقياس النتيجة الثانوي

    Number of participants with adverse events (AEs)

    الإطار الزمني Up to 2.5 years

  7. مقياس النتيجة الثانوي

    Number of participants with serious adverse events (SAEs)

    الإطار الزمني Up to 2.5 years

  8. مقياس النتيجة الثانوي

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

    الإطار الزمني Up to 2.5 years

  9. مقياس النتيجة الثانوي

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

    الإطار الزمني Up to 2 years

التواريخ

التواريخ
تاريخ البدء7 أكتوبر 2024 (فعلي)
الإتمام الأولي30 يوليو 2030 (تقديري)
الإتمام4 أغسطس 2032 (تقديري)
أول نشر20 أغسطس 2024 (فعلي)
آخر تحديث14 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

231 موقعاً قيد التجنيد

Argentina

Argentina
المنشأةالمدينةالولاية أو المنطقةالحالة
Hospital Italiano de Buenos AiresABBBuenos Aires F.D.قيد التجنيد
Local Institution - 0493BarilocheRío Negro Provinceلم يبدأ التجنيد بعد
Hospital Británico de Buenos AiresCiudad Autónoma de Buenos AiresBuenos Airesقيد التجنيد
Instituto Alexander FlemingCiudad Autónoma de Buenos AiresBuenos Airesقيد التجنيد
Hospital Privado Universitario de CórdobaCórdobaقيد التجنيد
Instituto Oncológico de CórdobaCórdobaقيد التجنيد
Hospital Privado de ComunidadMar del Plataقيد التجنيد
Sanatorio ParqueRosarioSanta Fe Provinceقيد التجنيد
Instituto Médico Río CuartoRío CuartoCórdoba Provinceقيد التجنيد

Australia

Australia
المنشأةالمدينةالولاية أو المنطقةالحالة
Box Hill HospitalBox HillVictoriaقيد التجنيد
The Prince Charles HospitalBrisbaneQueenslandقيد التجنيد
Gallipoli Medical Research LtdBrisbaneQueenslandقيد التجنيد
Local Institution - 0057Elizabeth ValeSouth Australiaلم يبدأ التجنيد بعد
Gosford HospitalGosfordNew South Walesقيد التجنيد
Fiona Stanley HospitalMurdochWestern Australiaقيد التجنيد
St. John of God Murdoch HospitalMurdochWestern Australiaقيد التجنيد
GenesisCare North ShoreSt LeonardsNew South Walesقيد التجنيد

Austria

Austria
المنشأةالمدينةالولاية أو المنطقةالحالة
Universitätsklinikum KremsKremsLower Austriaقيد التجنيد
Klinik FloridsdorfViennaقيد التجنيد
Klinikum Wels-Grieskirchen GmbHWelsUpper Austriaقيد التجنيد

Belgium

Belgium
المنشأةالمدينةالولاية أو المنطقةالحالة
UZ BrusselBrusselsBruxelles-Capitale, Région deقيد التجنيد
Antwerp University HospitalEdegemAntwerpenقيد التجنيد
Jessa ZiekenhuisHasseltLimburgقيد التجنيد
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart TilmanLiègeقيد التجنيد
AZ Delta vzwRoeselareWest-Vlaanderenقيد التجنيد
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodinneYvoirNamurقيد التجنيد

Brazil

Brazil
المنشأةالمدينةالولاية أو المنطقةالحالة
Fundação Pio XII - Hospital de Câncer de BarretosBarretosSão Pauloقيد التجنيد
NAIC - Instituto do CâncerBauruSão Pauloقيد التجنيد
Cetus Oncologia - Unidade Belo HorizonteBelo HorizonteMinas Geraisقيد التجنيد
CTO - Centro de Tratamento OncológicoBelémParáقيد التجنيد
PronutrirFortalezaCearáقيد التجنيد
Clínica de Neoplasias LitoralItajaíSanta Catarinaقيد التجنيد
Liga Norte Riograndense Contra o CâncerNatalRio Grande do Norteقيد التجنيد
Hospital São Lucas da PUCRSPorto AlegreRio Grande do Sulقيد التجنيد
Hospital de Clinicas de Porto AlegrePorto AlegreRio Grande do Sulقيد التجنيد
Instituto Nacional de Câncer - INCARio de Janeiroقيد التجنيد
Centro de Oncologia - CEON+ - Unidade São Caetano do SulSão Caetano do SulSão Pauloقيد التجنيد
Icesp - Instituto Do Câncer Do Estado de São PauloSão Pauloقيد التجنيد
Local Institution - 0496São Pauloلم يبدأ التجنيد بعد
Local Institution - 0497TaubatéSão Pauloلم يبدأ التجنيد بعد
Local Institution - 0501TimbóSanta Catarinaلم يبدأ التجنيد بعد

Canada

Canada
المنشأةالمدينةالولاية أو المنطقةالحالة
Local Institution - 0494MontrealQuebecلم يبدأ التجنيد بعد

Chile

Chile
المنشأةالمدينةالولاية أو المنطقةالحالة
Local Institution - 0495SantiagoVitacuraلم يبدأ التجنيد بعد
Orlandi OncologiaSantiagoSantiago Metropolitanقيد التجنيد
Fundacion Arturo Lopez Perez (FALP)SantiagoSantiago Metropolitanقيد التجنيد
Pontificia Universidad Catolica de ChileSantiagoSantiago Metropolitanقيد التجنيد
BradfordhillSantiagoSantiago Metropolitanقيد التجنيد
Oncocentro ApysViña del MarValparaisoقيد التجنيد

China

China
المنشأةالمدينةالولاية أو المنطقةالحالة
Beijing Cancer hospitalBeijingBeijing Municipalityقيد التجنيد
Hunan Cancer HospitalChangshaHunanقيد التجنيد

يُدرَج 276 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 14 سبتمبر 2026

    أُضيف موقع

    4 sites added (326 total)

    322326

  2. 17 أغسطس 2026

    أُضيف موقع

    2 sites added (322 total)

    320322