NCT04623775CompletedPhase 2
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 468 (actual)
- First submitted
- 5 Nov 2020
- Start date
- 17 Feb 2021
- Primary completion date
- 11 Jan 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Lung cancer
- NCT number
- NCT04623775
- EU CT number
- 2023-508372-10-00
- EudraCT number
- 2020-004026-31
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 468
- From 17 Feb 2021 to the primary completion date, 11 Jan 2024
- 114 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
Lab values
- Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
- Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Other
- Untreated CNS metastases.
- Leptomeningeal metastases (carcinomatous meningitis).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
- Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
- No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (114)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Cuiudad Autonoma de Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | La Rioja | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Río Cuarto | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Viedma | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| - Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| - Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Ballarat | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Bendigo | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Gosford | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Tamworth | Australia | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Completed |
| - Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Grosshansdorf | Germany | Completed |
| SLK-Kliniken Heilbronn GmbH Coordinator of this site? Confirm its status | Loewenstein | Germany | Completed |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Completed |
| MVZ fuer Haematologie und Onkologie Ravensburg GmbH Coordinator of this site? Confirm its status | Ravensburg | Germany | Completed |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Completed |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Unite De Recherche Clinique HIA Begin Coordinator of this site? Confirm its status | Saint-Mande | France | Completed |
| - Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin 4 | Ireland | Completed |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin 9 | Ireland | Completed |
| Azienda Ospedaliera Ospedali Riuniti Marche Nord Coordinator of this site? Confirm its status | Pesaro | Italy | Completed |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | San Pedro Garza García | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Toluca | Mexico | Unknown status |
| Rijnstate Ziekenhuis Stichting Coordinator of this site? Confirm its status | Arnhem | Netherlands | Completed |
| Ziekenhuis St Jansdal Coordinator of this site? Confirm its status | Harderwijk | Netherlands | Completed |
| Mandziuk Slawomir - Specjalistyczna Praktyka Lekarska Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Oncolab S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Onco Clinic Consult S.A. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Oncocenter Oncologie Clinica S.R.L Coordinator of this site? Confirm its status | Timișoara | Romania | Completed |
| Arkhangelsk Clinical Oncological Dispensary Coordinator of this site? Confirm its status | Arkhangelsk | Russia | Unknown status |
| FSBI ",Research Institute of Influenza named after A.A. Smorodintsev ",of the MoH of the Rus Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Llc, Eurocityclinic Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Harlingen | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Howell Township | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Johnson City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Port Saint Lucie | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| - Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
Related publications
- Nivolumab plus relatlimab with platinum-doublet chemotherapy versus nivolumab with platinum-doublet chemotherapy in stage IV or recurrent non-small cell lung cancer: clinical, translational, and patient-reported outcomes results from the phase II RELATIVITY-104 study.Ann Oncol · 2026 · PMID 42918419
This page is information, not medical advice. Discuss any trial with your doctor.