NCT06561386 · Bristol-Myers Squibb
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%
(RELATIVITY1093)
What this study is about
The purpose of this study is to compare the effectiveness 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%
View original scientific 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%
Interventions
DRUG
Nivolumab
Specified dose on specified days
DRUG
Relatlimab
Specified dose on specified days
DRUG
Pembrolizumab
Specified dose on specified days
DRUG
Carboplatin
Specified dose on specified days
DRUG
Pemetrexed
Specified dose on specified days
DRUG
Cisplatin
Specified dose on specified days
Primary outcome measures
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Time frame: Up to 5 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Participants must not be pregnant and/or breastfeeding.
- Participants with epidermal growth factor receptor (EGFR), anaplastic ly
Where
- Mobile, Alabama
- Tucson, Arizona
- Los Angeles, California
- Sacramento, California
- San Francisco, California
- Santa Monica, California
- Grand Junction, Colorado
- Westminster, Colorado
- Miami, Florida
- Pembroke Pines, Florida
- St. Petersburg, Florida
- Tamarac, Florida
And 38 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations