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 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
- ClinicalTrials.govNCT06561386Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 5 jours
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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.
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
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
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
| Sexe | Tous |
|---|---|
| Âges | 18 Years – Aucun maximum |
| Volontaires sains | Non |
Éligibilité telle qu'elle figure dans le registre
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
| Type d'étude | Interventionnelle |
|---|---|
| Phase | Phase 3 |
| Répartition | Randomisée |
| Modèle d'intervention | PARALLEL |
| Objectif principal | TREATMENT |
| Insu | NONE (0) |
| Recrutement | 1 000 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
Critère de jugement principal
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Délai Up to 5 years
Critère de jugement secondaire
OS in randomized participants with PD-L1 ≥ 1%
Délai Up to 5 years
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
Critère de jugement secondaire
Overall response rate (ORR)
Délai Up to 5 years
Critère de jugement secondaire
Duration of response (DoR)
Délai Up to 5 years
Critère de jugement secondaire
Number of participants with adverse events (AEs)
Délai Up to 2.5 years
Critère de jugement secondaire
Number of participants with serious adverse events (SAEs)
Délai Up to 2.5 years
Critère de jugement secondaire
Number of participants with immune-mediated adverse events (IMAEs)
Délai Up to 2.5 years
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
| Date de début | 7 octobre 2024 (réelle) |
|---|---|
| Achèvement principal | 30 juillet 2030 (estimée) |
| Achèvement | 4 août 2032 (estimée) |
| Première publication | 20 août 2024 (réelle) |
| Dernière mise à jour | 14 septembre 2026 |
| Résultats publiés | Non précisé dans la fiche du registre |
| Statut vérifié pour la dernière fois | septembre 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
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Hospital Italiano de Buenos Aires | ABB | Buenos Aires F.D. | En recrutement |
| Local Institution - 0493 | Bariloche | Río Negro Province | Pas encore en recrutement |
| Hospital Británico de Buenos Aires | Ciudad Autónoma de Buenos Aires | Buenos Aires | En recrutement |
| Instituto Alexander Fleming | Ciudad Autónoma de Buenos Aires | Buenos Aires | En recrutement |
| Hospital Privado Universitario de Córdoba | Córdoba | En recrutement | |
| Instituto Oncológico de Córdoba | Córdoba | En recrutement | |
| Hospital Privado de Comunidad | Mar del Plata | En recrutement | |
| Sanatorio Parque | Rosario | Santa Fe Province | En recrutement |
| Instituto Médico Río Cuarto | Río Cuarto | Córdoba Province | En recrutement |
Australia
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Box Hill Hospital | Box Hill | Victoria | En recrutement |
| The Prince Charles Hospital | Brisbane | Queensland | En recrutement |
| Gallipoli Medical Research Ltd | Brisbane | Queensland | En recrutement |
| Local Institution - 0057 | Elizabeth Vale | South Australia | Pas encore en recrutement |
| Gosford Hospital | Gosford | New South Wales | En recrutement |
| Fiona Stanley Hospital | Murdoch | Western Australia | En recrutement |
| St. John of God Murdoch Hospital | Murdoch | Western Australia | En recrutement |
| GenesisCare North Shore | St Leonards | New South Wales | En recrutement |
Austria
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Universitätsklinikum Krems | Krems | Lower Austria | En recrutement |
| Klinik Floridsdorf | Vienna | En recrutement | |
| Klinikum Wels-Grieskirchen GmbH | Wels | Upper Austria | En recrutement |
Belgium
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| UZ Brussel | Brussels | Bruxelles-Capitale, Région de | En recrutement |
| Antwerp University Hospital | Edegem | Antwerpen | En recrutement |
| Jessa Ziekenhuis | Hasselt | Limburg | En recrutement |
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Liège | En recrutement | |
| AZ Delta vzw | Roeselare | West-Vlaanderen | En recrutement |
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne | Yvoir | Namur | En recrutement |
Brazil
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | En recrutement |
| NAIC - Instituto do Câncer | Bauru | São Paulo | En recrutement |
| Cetus Oncologia - Unidade Belo Horizonte | Belo Horizonte | Minas Gerais | En recrutement |
| CTO - Centro de Tratamento Oncológico | Belém | Pará | En recrutement |
| Pronutrir | Fortaleza | Ceará | En recrutement |
| Clínica de Neoplasias Litoral | Itajaí | Santa Catarina | En recrutement |
| Liga Norte Riograndense Contra o Câncer | Natal | Rio Grande do Norte | En recrutement |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | En recrutement |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | En recrutement |
| Instituto Nacional de Câncer - INCA | Rio de Janeiro | En recrutement | |
| Centro de Oncologia - CEON+ - Unidade São Caetano do Sul | São Caetano do Sul | São Paulo | En recrutement |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | En recrutement | |
| Local Institution - 0496 | São Paulo | Pas encore en recrutement | |
| Local Institution - 0497 | Taubaté | São Paulo | Pas encore en recrutement |
| Local Institution - 0501 | Timbó | Santa Catarina | Pas encore en recrutement |
Canada
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Local Institution - 0494 | Montreal | Quebec | Pas encore en recrutement |
Chile
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Local Institution - 0495 | Santiago | Vitacura | Pas encore en recrutement |
| Orlandi Oncologia | Santiago | Santiago Metropolitan | En recrutement |
| Fundacion Arturo Lopez Perez (FALP) | Santiago | Santiago Metropolitan | En recrutement |
| Pontificia Universidad Catolica de Chile | Santiago | Santiago Metropolitan | En recrutement |
| Bradfordhill | Santiago | Santiago Metropolitan | En recrutement |
| Oncocentro Apys | Viña del Mar | Valparaiso | En recrutement |
China
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Beijing Cancer hospital | Beijing | Beijing Municipality | En recrutement |
| Hunan Cancer Hospital | Changsha | Hunan | En 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
- 14 septembre 2026
Site ajouté
4 sites added (326 total)
322326
- 17 août 2026
Site ajouté
2 sites added (322 total)
320322