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Compares treatment options for Non-small Cell Lung Cancer
Official 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%
ClinicalTrials.gov ID: NCT06561386
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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%
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no...
- Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1...
- 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.
You likely can't join if
- Participants must not be pregnant and/or breastfeeding.
- Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available...
- Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating...
- Participants must not have untreated central nervous system (CNS) metastases.
- Participants must not have leptomeningeal metastases (carcinomatous meningitis).
- Participants must not have concurrent malignancy requiring treatment.
See the full eligibility 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...
- 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...
- 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.
- Participants must not be pregnant and/or breastfeeding.
- 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...
- 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...
- Participants must not have untreated central nervous system (CNS) metastases.
- Participants must not have leptomeningeal metastases (carcinomatous meningitis).
- Participants must not have concurrent malignancy requiring treatment.
- 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 must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Grand Junction, Colorado, United States
- Westminster, Colorado, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- St. Petersburg, Florida, United States
- Tamarac, Florida, United States
- West Palm Beach, Florida, United States
- Coeur d'Alene, Idaho, United States
- Chicago Ridge, Illinois, United States
- Wichita, Kansas, United States
- Edgewood, Kentucky, United States
- Lexington, Kentucky, United States
- Paducah, Kentucky, United States
- Annapolis, Maryland, United States
+ 264 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Sacramento, California, United States; San Francisco, California, United States; Santa Monica, California, United States and 278 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.