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%

RecruitingTaking participants now, according to the registry record.

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In brief

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 sought326 sites31 countries

Registered in 1 registry

ClinicalTrials.govNCT06561386Open this record at ClinicalTrials.govSynced 5 days ago

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Trial information is shown as published by the registry, in its original language.

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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.

Summary

Conditions

Non-small Cell Lung Cancer

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	1,000 participants sought

Sponsor and collaborators

Bristol-Myers Squibb Sponsor

Arms and interventions

Arm AEXPERIMENTAL
Arm BACTIVE_COMPARATOR

Interventions

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

Outcome measures

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

Dates

Dates
Start date	October 7, 2024 (actual)
Primary completion	July 30, 2030 (estimated)
Completion	August 4, 2032 (estimated)
First posted	August 20, 2024 (actual)
Last updated	September 14, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

231 sites are recruiting

Argentina

Argentina
Facility	City	State or region	Status
Hospital Italiano de Buenos Aires	ABB	Buenos Aires F.D.	Recruiting
Local Institution - 0493	Bariloche	Río Negro Province	Not yet recruiting
Hospital Británico de Buenos Aires	Ciudad Autónoma de Buenos Aires	Buenos Aires	Recruiting
Instituto Alexander Fleming	Ciudad Autónoma de Buenos Aires	Buenos Aires	Recruiting
Hospital Privado Universitario de Córdoba	Córdoba		Recruiting
Instituto Oncológico de Córdoba	Córdoba		Recruiting
Hospital Privado de Comunidad	Mar del Plata		Recruiting
Sanatorio Parque	Rosario	Santa Fe Province	Recruiting
Instituto Médico Río Cuarto	Río Cuarto	Córdoba Province	Recruiting

Australia

Australia
Facility	City	State or region	Status
Box Hill Hospital	Box Hill	Victoria	Recruiting
The Prince Charles Hospital	Brisbane	Queensland	Recruiting
Gallipoli Medical Research Ltd	Brisbane	Queensland	Recruiting
Local Institution - 0057	Elizabeth Vale	South Australia	Not yet recruiting
Gosford Hospital	Gosford	New South Wales	Recruiting
Fiona Stanley Hospital	Murdoch	Western Australia	Recruiting
St. John of God Murdoch Hospital	Murdoch	Western Australia	Recruiting
GenesisCare North Shore	St Leonards	New South Wales	Recruiting

Austria

Austria
Facility	City	State or region	Status
Universitätsklinikum Krems	Krems	Lower Austria	Recruiting
Klinik Floridsdorf	Vienna		Recruiting
Klinikum Wels-Grieskirchen GmbH	Wels	Upper Austria	Recruiting

Belgium

Belgium
Facility	City	State or region	Status
UZ Brussel	Brussels	Bruxelles-Capitale, Région de	Recruiting
Antwerp University Hospital	Edegem	Antwerpen	Recruiting
Jessa Ziekenhuis	Hasselt	Limburg	Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman	Liège		Recruiting
AZ Delta vzw	Roeselare	West-Vlaanderen	Recruiting
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne	Yvoir	Namur	Recruiting

Brazil

Brazil
Facility	City	State or region	Status
Fundação Pio XII - Hospital de Câncer de Barretos	Barretos	São Paulo	Recruiting
NAIC - Instituto do Câncer	Bauru	São Paulo	Recruiting
Cetus Oncologia - Unidade Belo Horizonte	Belo Horizonte	Minas Gerais	Recruiting
CTO - Centro de Tratamento Oncológico	Belém	Pará	Recruiting
Pronutrir	Fortaleza	Ceará	Recruiting
Clínica de Neoplasias Litoral	Itajaí	Santa Catarina	Recruiting
Liga Norte Riograndense Contra o Câncer	Natal	Rio Grande do Norte	Recruiting
Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande do Sul	Recruiting
Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Recruiting
Instituto Nacional de Câncer - INCA	Rio de Janeiro		Recruiting
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul	São Caetano do Sul	São Paulo	Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo	São Paulo		Recruiting
Local Institution - 0496	São Paulo		Not yet recruiting
Local Institution - 0497	Taubaté	São Paulo	Not yet recruiting
Local Institution - 0501	Timbó	Santa Catarina	Not yet recruiting

Canada

Canada
Facility	City	State or region	Status
Local Institution - 0494	Montreal	Quebec	Not yet recruiting

Chile

Chile
Facility	City	State or region	Status
Local Institution - 0495	Santiago	Vitacura	Not yet recruiting
Orlandi Oncologia	Santiago	Santiago Metropolitan	Recruiting
Fundacion Arturo Lopez Perez (FALP)	Santiago	Santiago Metropolitan	Recruiting
Pontificia Universidad Catolica de Chile	Santiago	Santiago Metropolitan	Recruiting
Bradfordhill	Santiago	Santiago Metropolitan	Recruiting
Oncocentro Apys	Viña del Mar	Valparaiso	Recruiting

China

China
Facility	City	State or region	Status
Beijing Cancer hospital	Beijing	Beijing Municipality	Recruiting
Hunan Cancer Hospital	Changsha	Hunan	Recruiting

276 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 14, 2026
Site added
4 sites added (326 total)
322326
August 17, 2026
Site added
2 sites added (322 total)
320322

Registry: ClinicalTrials.gov · NCT########

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

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Austria

Belgium

Brazil

Canada

Chile

China

Study documents

Changes over time