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%

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

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 Teilnehmende gesucht326 Studienzentren31 Länder

Kategorien

Onkologie79%Atemwege21%

In 1 Register registriert

ClinicalTrials.govNCT06561386Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 5 Tagen

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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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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.

Zusammenfassung

Erkrankungen

Non-small Cell Lung Cancer

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	1.000 Teilnehmende gesucht

Sponsor und Mitwirkende

Bristol-Myers Squibb Sponsor

Studienarme und Interventionen

Arm AEXPERIMENTAL
Arm BACTIVE_COMPARATOR

Interventionen

Arzneimittel Carboplatin
Specified dose on specified days
Arzneimittel Cisplatin
Specified dose on specified days
Arzneimittel Nivolumab
Specified dose on specified days
Arzneimittel Pembrolizumab
Specified dose on specified days
Arzneimittel Pemetrexed
Specified dose on specified days
Arzneimittel Relatlimab
Specified dose on specified days

Endpunkte

Primärer Endpunkt
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
OS in randomized participants with PD-L1 ≥ 1%
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
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)
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
Overall response rate (ORR)
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
Duration of response (DoR)
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
Number of participants with adverse events (AEs)
Zeitrahmen Up to 2.5 years
Sekundärer Endpunkt
Number of participants with serious adverse events (SAEs)
Zeitrahmen Up to 2.5 years
Sekundärer Endpunkt
Number of participants with immune-mediated adverse events (IMAEs)
Zeitrahmen Up to 2.5 years
Sekundärer Endpunkt
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
Zeitrahmen Up to 2 years

Daten

Daten
Startdatum	7. Oktober 2024 (tatsächlich)
Primärer Abschluss	30. Juli 2030 (geschätzt)
Abschluss	4. August 2032 (geschätzt)
Erstveröffentlichung	20. August 2024 (tatsächlich)
Zuletzt aktualisiert	14. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	September 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

231 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Bundesland oder Region	Status
Hospital Italiano de Buenos Aires	ABB	Buenos Aires F.D.	Rekrutiert
Local Institution - 0493	Bariloche	Río Negro Province	Rekrutierung noch nicht begonnen
Hospital Británico de Buenos Aires	Ciudad Autónoma de Buenos Aires	Buenos Aires	Rekrutiert
Instituto Alexander Fleming	Ciudad Autónoma de Buenos Aires	Buenos Aires	Rekrutiert
Hospital Privado Universitario de Córdoba	Córdoba		Rekrutiert
Instituto Oncológico de Córdoba	Córdoba		Rekrutiert
Hospital Privado de Comunidad	Mar del Plata		Rekrutiert
Sanatorio Parque	Rosario	Santa Fe Province	Rekrutiert
Instituto Médico Río Cuarto	Río Cuarto	Córdoba Province	Rekrutiert

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Box Hill Hospital	Box Hill	Victoria	Rekrutiert
The Prince Charles Hospital	Brisbane	Queensland	Rekrutiert
Gallipoli Medical Research Ltd	Brisbane	Queensland	Rekrutiert
Local Institution - 0057	Elizabeth Vale	South Australia	Rekrutierung noch nicht begonnen
Gosford Hospital	Gosford	New South Wales	Rekrutiert
Fiona Stanley Hospital	Murdoch	Western Australia	Rekrutiert
St. John of God Murdoch Hospital	Murdoch	Western Australia	Rekrutiert
GenesisCare North Shore	St Leonards	New South Wales	Rekrutiert

Austria

Austria
Einrichtung	Stadt	Bundesland oder Region	Status
Universitätsklinikum Krems	Krems	Lower Austria	Rekrutiert
Klinik Floridsdorf	Vienna		Rekrutiert
Klinikum Wels-Grieskirchen GmbH	Wels	Upper Austria	Rekrutiert

Belgium

Belgium
Einrichtung	Stadt	Bundesland oder Region	Status
UZ Brussel	Brussels	Bruxelles-Capitale, Région de	Rekrutiert
Antwerp University Hospital	Edegem	Antwerpen	Rekrutiert
Jessa Ziekenhuis	Hasselt	Limburg	Rekrutiert
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman	Liège		Rekrutiert
AZ Delta vzw	Roeselare	West-Vlaanderen	Rekrutiert
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne	Yvoir	Namur	Rekrutiert

Brazil

Brazil
Einrichtung	Stadt	Bundesland oder Region	Status
Fundação Pio XII - Hospital de Câncer de Barretos	Barretos	São Paulo	Rekrutiert
NAIC - Instituto do Câncer	Bauru	São Paulo	Rekrutiert
Cetus Oncologia - Unidade Belo Horizonte	Belo Horizonte	Minas Gerais	Rekrutiert
CTO - Centro de Tratamento Oncológico	Belém	Pará	Rekrutiert
Pronutrir	Fortaleza	Ceará	Rekrutiert
Clínica de Neoplasias Litoral	Itajaí	Santa Catarina	Rekrutiert
Liga Norte Riograndense Contra o Câncer	Natal	Rio Grande do Norte	Rekrutiert
Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande do Sul	Rekrutiert
Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Rekrutiert
Instituto Nacional de Câncer - INCA	Rio de Janeiro		Rekrutiert
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul	São Caetano do Sul	São Paulo	Rekrutiert
Icesp - Instituto Do Câncer Do Estado de São Paulo	São Paulo		Rekrutiert
Local Institution - 0496	São Paulo		Rekrutierung noch nicht begonnen
Local Institution - 0497	Taubaté	São Paulo	Rekrutierung noch nicht begonnen
Local Institution - 0501	Timbó	Santa Catarina	Rekrutierung noch nicht begonnen

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Local Institution - 0494	Montreal	Quebec	Rekrutierung noch nicht begonnen

Chile

Chile
Einrichtung	Stadt	Bundesland oder Region	Status
Local Institution - 0495	Santiago	Vitacura	Rekrutierung noch nicht begonnen
Orlandi Oncologia	Santiago	Santiago Metropolitan	Rekrutiert
Fundacion Arturo Lopez Perez (FALP)	Santiago	Santiago Metropolitan	Rekrutiert
Pontificia Universidad Catolica de Chile	Santiago	Santiago Metropolitan	Rekrutiert
Bradfordhill	Santiago	Santiago Metropolitan	Rekrutiert
Oncocentro Apys	Viña del Mar	Valparaiso	Rekrutiert

China

China
Einrichtung	Stadt	Bundesland oder Region	Status
Beijing Cancer hospital	Beijing	Beijing Municipality	Rekrutiert
Hunan Cancer Hospital	Changsha	Hunan	Rekrutiert

276 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

14. September 2026
Studienzentrum hinzugefügt
4 sites added (326 total)
322326
17. August 2026
Studienzentrum hinzugefügt
2 sites added (322 total)
320322

https://xmedica.io/trials/ctgov/NCT06561386