Compares two immunotherapy combinations with chemotherapy for advanced lung cancer
Compares nivolumab with relatlimab plus chemotherapy against pembrolizumab plus chemotherapy in adults.
Plain-language title generated from the registry record
Registry title: 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%
Key facts
- Where
- Berlin, Bonn, Chemnitz, Dortmund, Essen, Esslingen am Neckar, Gauting, Grosshansdorf, Hannover, Herne, Kempten (Allgau), Luebeck, Marburg, Muenster, Munich, and Ulm, GermanySee the 16 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- What was the PD-L1 result of your tumour test?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT06561386, who can take part
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Klinikum Chemnitz gGmbHChemnitz, GermanyTaking people
- GEFOS Gesellschaft fuer onkologische Studien Dortmund mbHDortmund, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Klinikum Esslingen GmbHEsslingen am Neckar, GermanyTaking people
- Asklepios Klinik Gauting GmbHGauting, GermanyTaking people
- LungenClinic Grosshansdorf GmbHGrosshansdorf, GermanyTaking people
- Onkologie am Raschplatz Dr. Ingo Zander & Dr. Eyck von der HeydeHannover, GermanyTaking people
- Evangelische Krankenhausgemeinschaft Herne/Castrop-Rauxel gGmbHHerne, GermanyTaking people
- Klinikverbund Allgaeu gGmbHKempten (Allgau), GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, GermanyTaking people
- Philipps-Universitaet MarburgMarburg, GermanyTaking people
- Universitaet MuensterMuenster, GermanyTaking people
- Klinikum der Universitaet Muenchen AöRMunich, GermanyTaking people
- Bundeswehrkrankenhaus UlmUlm, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06561386EU 2024-513682-40-01
- Record updated
- 9 November 2026
- Original description
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%Read full original descriptionShow less
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%
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%
Inclusion: 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: 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 concurrent malignancy requiring treatment; Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Note: Anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy given in an adjuvant, neoadjuvant or perioperative setting with at least 6 months between the last dose and date of recurrence are allowed; 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 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 must not be pregnant and/or breastfeeding; Participants must not have untreated central nervous system (CNS) metastases; Participants must not have leptomeningeal metastases (carcinomatous meningitis); Other protocol-defined Inclusion/Exclusion criteria apply.