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%
In breve
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%
Fase 31000 partecipanti ricercati326 centri31 paesi
Categorie
Registrato in 1 registro
- ClinicalTrials.govNCT06561386Apri questa scheda su ClinicalTrials.govSincronizzato 5 giorni fa
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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.
Sintesi
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%
Patologie
- Non-small Cell Lung Cancer
Idoneità
| Sesso | Tutti |
|---|---|
| Età | 18 Years – Nessun massimo |
| Volontari sani | No |
Idoneità come riportata nel registro
Idoneità in frasi semplici
I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.
Disegno dello studio
| Tipo di studio | Interventistico |
|---|---|
| Fase | Fase 3 |
| Assegnazione | Randomizzata |
| Modello di intervento | PARALLEL |
| Finalità principale | TREATMENT |
| Mascheramento | NONE (0) |
| Arruolamento | 1000 partecipanti ricercati |
Sponsor e collaboratori
- Bristol-Myers Squibb Sponsor
Bracci e interventi
- Arm AEXPERIMENTAL
- Arm BACTIVE_COMPARATOR
Interventi
- Farmaco Carboplatin
Specified dose on specified days
- Farmaco Cisplatin
Specified dose on specified days
- Farmaco Nivolumab
Specified dose on specified days
- Farmaco Pembrolizumab
Specified dose on specified days
- Farmaco Pemetrexed
Specified dose on specified days
- Farmaco Relatlimab
Specified dose on specified days
Esiti misurati
Esito primario
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Orizzonte temporale Up to 5 years
Esito secondario
OS in randomized participants with PD-L1 ≥ 1%
Orizzonte temporale Up to 5 years
Esito secondario
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)
Orizzonte temporale Up to 5 years
Esito secondario
Overall response rate (ORR)
Orizzonte temporale Up to 5 years
Esito secondario
Duration of response (DoR)
Orizzonte temporale Up to 5 years
Esito secondario
Number of participants with adverse events (AEs)
Orizzonte temporale Up to 2.5 years
Esito secondario
Number of participants with serious adverse events (SAEs)
Orizzonte temporale Up to 2.5 years
Esito secondario
Number of participants with immune-mediated adverse events (IMAEs)
Orizzonte temporale Up to 2.5 years
Esito secondario
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
Orizzonte temporale Up to 2 years
Date
| Data di inizio | 7 ottobre 2024 (effettiva) |
|---|---|
| Conclusione primaria | 30 luglio 2030 (stimata) |
| Conclusione | 4 agosto 2032 (stimata) |
| Prima pubblicazione | 20 agosto 2024 (effettiva) |
| Ultimo aggiornamento | 14 settembre 2026 |
| Risultati pubblicati | Non indicato nella scheda del registro |
| Stato verificato l'ultima volta | settembre 2026 |
«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.
Centri
231 centri stanno reclutando
Argentina
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Hospital Italiano de Buenos Aires | ABB | Buenos Aires F.D. | In reclutamento |
| Local Institution - 0493 | Bariloche | Río Negro Province | Non ancora in reclutamento |
| Hospital Británico de Buenos Aires | Ciudad Autónoma de Buenos Aires | Buenos Aires | In reclutamento |
| Instituto Alexander Fleming | Ciudad Autónoma de Buenos Aires | Buenos Aires | In reclutamento |
| Hospital Privado Universitario de Córdoba | Córdoba | In reclutamento | |
| Instituto Oncológico de Córdoba | Córdoba | In reclutamento | |
| Hospital Privado de Comunidad | Mar del Plata | In reclutamento | |
| Sanatorio Parque | Rosario | Santa Fe Province | In reclutamento |
| Instituto Médico Río Cuarto | Río Cuarto | Córdoba Province | In reclutamento |
Australia
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Box Hill Hospital | Box Hill | Victoria | In reclutamento |
| The Prince Charles Hospital | Brisbane | Queensland | In reclutamento |
| Gallipoli Medical Research Ltd | Brisbane | Queensland | In reclutamento |
| Local Institution - 0057 | Elizabeth Vale | South Australia | Non ancora in reclutamento |
| Gosford Hospital | Gosford | New South Wales | In reclutamento |
| Fiona Stanley Hospital | Murdoch | Western Australia | In reclutamento |
| St. John of God Murdoch Hospital | Murdoch | Western Australia | In reclutamento |
| GenesisCare North Shore | St Leonards | New South Wales | In reclutamento |
Austria
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Universitätsklinikum Krems | Krems | Lower Austria | In reclutamento |
| Klinik Floridsdorf | Vienna | In reclutamento | |
| Klinikum Wels-Grieskirchen GmbH | Wels | Upper Austria | In reclutamento |
Belgium
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| UZ Brussel | Brussels | Bruxelles-Capitale, Région de | In reclutamento |
| Antwerp University Hospital | Edegem | Antwerpen | In reclutamento |
| Jessa Ziekenhuis | Hasselt | Limburg | In reclutamento |
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Liège | In reclutamento | |
| AZ Delta vzw | Roeselare | West-Vlaanderen | In reclutamento |
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne | Yvoir | Namur | In reclutamento |
Brazil
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | In reclutamento |
| NAIC - Instituto do Câncer | Bauru | São Paulo | In reclutamento |
| Cetus Oncologia - Unidade Belo Horizonte | Belo Horizonte | Minas Gerais | In reclutamento |
| CTO - Centro de Tratamento Oncológico | Belém | Pará | In reclutamento |
| Pronutrir | Fortaleza | Ceará | In reclutamento |
| Clínica de Neoplasias Litoral | Itajaí | Santa Catarina | In reclutamento |
| Liga Norte Riograndense Contra o Câncer | Natal | Rio Grande do Norte | In reclutamento |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | In reclutamento |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | In reclutamento |
| Instituto Nacional de Câncer - INCA | Rio de Janeiro | In reclutamento | |
| Centro de Oncologia - CEON+ - Unidade São Caetano do Sul | São Caetano do Sul | São Paulo | In reclutamento |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | In reclutamento | |
| Local Institution - 0496 | São Paulo | Non ancora in reclutamento | |
| Local Institution - 0497 | Taubaté | São Paulo | Non ancora in reclutamento |
| Local Institution - 0501 | Timbó | Santa Catarina | Non ancora in reclutamento |
Canada
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0494 | Montreal | Quebec | Non ancora in reclutamento |
Chile
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0495 | Santiago | Vitacura | Non ancora in reclutamento |
| Orlandi Oncologia | Santiago | Santiago Metropolitan | In reclutamento |
| Fundacion Arturo Lopez Perez (FALP) | Santiago | Santiago Metropolitan | In reclutamento |
| Pontificia Universidad Catolica de Chile | Santiago | Santiago Metropolitan | In reclutamento |
| Bradfordhill | Santiago | Santiago Metropolitan | In reclutamento |
| Oncocentro Apys | Viña del Mar | Valparaiso | In reclutamento |
China
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Beijing Cancer hospital | Beijing | Beijing Municipality | In reclutamento |
| Hunan Cancer Hospital | Changsha | Hunan | In reclutamento |
Nella scheda del registro sono indicati altri 276 centri.
Documenti dello studio
In questa scheda del registro non sono collegati documenti.
Modifiche nel tempo
- 14 settembre 2026
Centro aggiunto
4 sites added (326 total)
322326
- 17 agosto 2026
Centro aggiunto
2 sites added (322 total)
320322