Taking people in ItalyPhase 3
Compares two immunotherapy combinations with chemotherapy for advanced lung cancer
Compares nivolumab with relatlimab plus chemotherapy against pembrolizumab plus chemotherapy in adults.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Bari, Bergamo, Florence, Milan, Naples, Palermo, Peschiera del Garda, Ravenna, Rome, and Siena, ItalySee the 12 sitesAlso in 30 other countries, 305 sites
- Trial code
- NCT06561386
- EU 2024-513682-40-01
- U1111-1306-8896
- 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%
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,000 people, planned
- Started
- 7 Oct 2024
- Expected to end
- 4 Aug 2032
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Nivolumab
- Relatlimab
- Pembrolizumab
- Carboplatin
- Pemetrexed
- Cisplatin
- Record updated
- 9 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage IV or recurrent non-squamous non-small cell lung cancer who have not had drug treatment for advanced disease and whose tumour has PD-L1 of 1% or more.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Stage IV or recurrent non-squamous non-small cell lung cancer, confirmed by tissue tests. The disease must be measurable on CT or MRI.
- Earlier treatment
- No earlier drug treatment for advanced or metastatic disease. No earlier anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody, except as given around surgery with at least 6 months before the cancer came back.
- Biomarker or test result
- PD-L1 tumour cell score of 1% or more, measured by the central laboratory test VENTANA PD-L1 (SP263) CDx Assay. EGFR, ALK and ROS-1 status must be known and not sensitive to targeted drugs.
Main reasons for not taking part
- Pregnant or breastfeeding
- EGFR, ALK or ROS-1 mutation sensitive to targeted drugs, or unknown status
- Known BRAFV600E mutation sensitive to targeted drugs, or known RET mutation or NTRK fusion
- Untreated brain or spinal cord metastases, or leptomeningeal metastases
- Active autoimmune disease, or a history of myocarditis
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
Also in 30 other countries, 305 sites
- Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
- Cliniche Gavazzeni S.p.A.Bergamo, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Azienda Ospedaliera dei ColliNaples, ItalyTaking people
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyTaking people
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.Peschiera del Garda, ItalyTaking people
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
- San Camillo Forlanini HospitalRome, ItalyTaking people
- Azienda Ospedaliero Universitaria SeneseSiena, ItalyTaking people
About the trial
What the trial wants to find out
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%
The 2 groups in the trial
- Arm ATreatment being tested
Treatment: Nivolumab, Relatlimab, Carboplatin, Pemetrexed, and Cisplatin
- Arm BExisting treatment, for comparison
Treatment: Pembrolizumab, Carboplatin, Pemetrexed, and Cisplatin
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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%
- Plain-language title
- Compares two immunotherapy combinations with chemotherapy for advanced lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06561386, who can take part
- Record updated
- 9 November 2026