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Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
EU CTIS ID: 2024-515052-20-00
What this study is testing
The primary objectives of the study are to compare the overall survival (OS) and progression-free survival (PFS) of REGN2810 (cemiplimab) versus standard-of care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand-1 (PD-L1) in ≥50% of tumor cells.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
- Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
- Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
- At least 1 radiographically measureable lesion per RECIST 1.1
- ECOG performance status of ≤1
- Anticipated life expectancy of at least 3 months
You likely can't join if
- Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
- Active infection requiring systemic therapy within 14 days prior to randomization
- Prior therapy with anti-PD 1 or anti-PD L1
- Treatment-related immune-mediated AEs from immune-modulatory agents
- Receipt of an investigational drug or device within 30 days
- Receipt of a live vaccine within 30 days of planned start of study medication
See the full eligibility criteria
- Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
- Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
- Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
- At least 1 radiographically measureable lesion per RECIST 1.1
- ECOG performance status of ≤1
- Anticipated life expectancy of at least 3 months
- Adequate organ and bone marrow function
- Note: Other protocol defined Inclusion criteria apply.
- Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
- Active infection requiring systemic therapy within 14 days prior to randomization
- Prior therapy with anti-PD 1 or anti-PD L1
- Treatment-related immune-mediated AEs from immune-modulatory agents
- Receipt of an investigational drug or device within 30 days
- Receipt of a live vaccine within 30 days of planned start of study medication
- Major surgery or significant traumatic injury within 4 weeks prior to first dose
- Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
- Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
- Pregnant or breastfeeding women
- Women of childbearing potential or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
- Active or untreated brain metastases or spinal cord compression
- Note: Other protocol defined Exclusion criteria apply.
- Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to randomization
- Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
- Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
- Another malignancy that is progressing or requires treatment
- Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Turkey
- Russian Federation
- Lebanon
- Chile
- Mexico
- Brazil
- Belarus
- Australia
- Thailand
- Jordan
- Philippines
- Taiwan
- Malaysia
- Ukraine
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Turkey; Russian Federation; Lebanon; Chile; Mexico and 9 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 EU CTIS; the study team decides eligibility.