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%
Recruiting · NCT06561386 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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%
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 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 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 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.
Where it is running
60 locations listed across 24 US states.
- Local Institution - 0487 - Mobile, Alabama, United States
- Southern Arizona VA Health Care System - Tucson, Arizona, United States
- Local Institution - 0112 - Los Angeles, California, United States
- University of California Davis (UC Davis) Comprehensive Cancer Center - Sacramento, California, United States
- San Francisco Oncology Associates - San Francisco, California, United States
- UCLA Hematology/Oncology - Santa Monica - Santa Monica, California, United States
- Local Institution - 0500 - Grand Junction, Colorado, United States
- Local Institution - 0472 - Westminster, Colorado, United States
- University of Miami Hospital and Clinics, Sylvester Cancer Center - Miami, Florida, United States
- Memorial Hospital West - Pembroke Pines, Florida, United States
- Florida Cancer Specialists - North - St. Petersburg, Florida, United States
- Local Institution - 0477 - Tamarac, Florida, United States
- Florida Cancer Specialists - East - West Palm Beach, Florida, United States
- Local Institution - 0509 - Coeur d'Alene, Idaho, United States
- Affiliated Oncologists, LLC - Chicago Ridge, Illinois, United States
- Cancer Center of Kansas - Wichita, Kansas, United States
- Saint Elizabeth Medical Center Edgewood - Edgewood, Kentucky, United States
- Baptist Health Lexington - Lexington, Kentucky, United States
- Local Institution - 0502 - Paducah, Kentucky, United States
- Local Institution - 0505 - Annapolis, Maryland, United States
- Local Institution - 0473 - Royal Oak, Michigan, United States
- Hattiesburg Clinic Hematology/Oncology - Hattiesburg, Mississippi, United States
- Local Institution - 0498 - Kansas City, Missouri, United States
- Local Institution - 0308 - Bozeman, Montana, United States
- Renown Regional Medical Center - Reno, Nevada, United States
- Local Institution - 0507 - Morristown, New Jersey, United States
- Local Institution - 0346 - Paterson, New Jersey, United States
- Local Institution - 0381 - Albuquerque, New Mexico, United States
- Local Institution - 0356 - Hawthorne, New York, United States
- Veterans Affairs New York Harbor Healthcare System - New York, New York, United States
- Local Institution - 0380 - Northport, New York, United States
- University of Rochester Medical Center - Rochester, New York, United States
- Local Institution - 0511 - Schenectady, New York, United States
- SUNY Upstate Medical University - Syracuse, New York, United States
- Local Institution - 0357 - The Bronx, New York, United States
- Local Institution - 0352 - Asheville, North Carolina, United States
- East Carolina University - Greenville, North Carolina, United States
- Local Institution - 0369 - Canton, Ohio, United States
- Local Institution - 0486 - Centerville, Ohio, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- Local Institution - 0199 - Cleveland, Ohio, United States
- Local Institution - 0366 - Massillon, Ohio, United States
- Local Institution - 0512 - Zanesville, Ohio, United States
- Lancaster General Hospital - Ann B Barshinger Cancer Institute - Lancaster, Pennsylvania, United States
- Local Institution - 0504 - Philadelphia, Pennsylvania, United States
- Texas Oncology - West Texas - Abilene, Texas, United States
- Local Institution - 0305 - Harlingen, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center - Tyler, Texas, United States
- Local Institution - 0302 - Salt Lake City, Utah, United States
- Local Institution - 0499 - Lacey, Washington, United States
- Local Institution - 0508 - Seattle, Washington, United States
- Adana Medical Park Seyhan Hastanesi - Adana, Turkey (Türkiye)
- Adana City Hospital - Adana, Turkey (Türkiye)
- Hyogo Cancer Center - Akashi, Japan
- Hacettepe Universite Hastaneleri - Ankara, Turkey (Türkiye)
- Local Institution - 0362 - Ankara, Turkey (Türkiye)
- Ziekenhuis Rijnstate - Arnhem, Netherlands
- Auckland City Hospital - Auckland, New Zealand
- Local Institution - 0290 - Basel, Switzerland
Showing 60 of 322 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →