Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer
3 other identifiers
interventional
712
24 countries
192
Brief Summary
The primary objectives of the study are:
- To compare the overall survival (OS) of 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 PD-L1 in ≥50% of tumor cells
- To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2017
Longer than P75 for phase_3
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2017
CompletedStudy Start
First participant enrolled
May 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2025
CompletedFebruary 23, 2026
February 1, 2026
7.9 years
March 3, 2017
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival (OS)
From date of randomization until the date of death, assessed up to 68 months
Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1
PFS as assessed by a blinded IRC using RECIST 1.1.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
Secondary Outcomes (11)
Objective response rates (ORR)
From date of randomization to the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first, up to 68 months
Best overall response (BOR)
From date of randomization until the date of first documented progression or the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months
Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Baseline up to 26 months after treatment
Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13)
Baseline up to 26 months after treatment
- +6 more secondary outcomes
Study Arms (2)
Standard-of-care chemotherapy
ACTIVE COMPARATORStandard-of-care chemotherapy will administered from these options: Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance
cemiplimab
EXPERIMENTALcemiplimab regimen as monotherapy as per study protocol
Interventions
Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Patients will be administered cemiplimab as per protocol.
Eligibility Criteria
You may qualify 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
- Adequate organ and bone marrow function
You may not qualify if:
- A patient who meets any of the following criteria will be excluded from the study:
- Patients that have never smoked, defined as smoking \<100 cigarettes in a lifetime
- Active or untreated brain metastases or spinal cord compression
- 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
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (192)
Clinical Study Site
Albury, New South Wales, Australia
Clinical Study Site
Wollongong, New South Wales, Australia
Clinical Study Site
Fitzroy, Australia
Clinical Study Site
Minsk, Belarus
Clinical Study Site
Mogilev, Belarus
Clinical Study Site 1
Porto Alegre, Rio Grande do Sul, Brazil
Clinical Study Site
Barretos, Brazil
Clinical Study Site
Curitiba, Brazil
Clinical Study Site
Joinville, Brazil
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Lajeado, Brazil
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Mogi das Cruzes, Brazil
Clinical Study Site
Passo Fundo, Brazil
Clinical Study Site
Pelotas, Brazil
Clinical Study Site 2
Porto Alegre, Brazil
Clinical Study Site 3
Porto Alegre, Brazil
Clinical Study Site
Recife, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
Clinical Study Site
Santa Cecília, Brazil
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São José do Rio Preto, Brazil
Clinical Study Site #3
São Paulo, Brazil
Clinical Study Site #4
São Paulo, Brazil
Clinical Study Site 1
São Paulo, Brazil
Clinical Study Site 2
São Paulo, Brazil
Clinical Study Site
Dobrich, Bulgaria
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Gabrovo, Bulgaria
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Recoleta, Chile
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Santiago, Chile
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Temuco, Chile
Clincial Study Site
Viña del Mar, Chile
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Lanshan, Shandong, China
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Guangdong, China
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Harbin, China
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Linyi, China
Clinical Study Site 1
Shanghai, China
Clinical Study Site 2
Shanghai, China
Clinical Study Site 1
Tianjin, China
Clinical Study Site 2
Tianjin, China
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Xuzhou, China
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Zhejiang, China
Clinical Study Site
Barranquilla, Colombia
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Bogotá, Colombia
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Floridablanca, Colombia
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Nový Jičín, Czechia
Clinical Study Site
Pelhřimov, Czechia
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Prague, Czechia
Clinical Study Site
Batumi, Georgia
Clinical Study Site #6
Tbilisi, Georgia
Clinical Study Site 1
Tbilisi, Georgia
Clinical Study Site 2
Tbilisi, Georgia
Clinical Study Site 3
Tbilisi, Georgia
Clinical Study Site 4
Tbilisi, Georgia
Clinical Study Site 5
Tbilisi, Georgia
Clinical Study Site
Pátrai, Achaia, Greece
Clinical Study Site
Cholargós, Attica, Greece
Clinical Study Site 1
Athens, Greece
Clinical Study Site 2
Athens, Greece
Clinical Study Site 3
Athens, Greece
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Larissa, Greece
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Pylaia, Greece
Clinical Study Site 1
Thessaloniki, Greece
Clinical Study Site 2
Thessaloniki, Greece
Clinical Study Site 3
Thessaloniki, Greece
Clinical Study Site
Gyula, Bekes County, Hungary
Clinical Study Site
Tatabánya, Komárom-Esztergom, Hungary
Clinical Study Site
Farkasgyepű, Veszprém megye, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Zalaegerszeg, Hungary
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Amman, Jordan
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Irbid, Jordan
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Bsalîm, Lebanon
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Mazraat ech Choûf, Lebanon
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Sidon, Lebanon
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Kampung Baharu Nilai, Malaysia
Clinical Study Site #1
Kuala Lumpur, Malaysia
Clinical Study Site #2
Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Pulau Pinang, Malaysia
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Tanjong Bungah, Malaysia
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Coahuila, Mexico
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Cuautitlán, Mexico
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Jalisco, Mexico
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León, Mexico
Clinical Study Site 1
Monterrey, Mexico
Clinical Study Site 2
Monterrey, Mexico
Clinical Study Site 3
Monterrey, Mexico
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Oaxaca City, Mexico
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San Luis Potosí City, Mexico
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Bacolod City, Philippines
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Batangas, Philippines
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Cebu, Philippines
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City of Taguig, Philippines
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Davao City, Philippines
Clinical Study Site 1
Manila, Philippines
Clinical Study Site 2
Manila, Philippines
Clinical Study Site #1
Quezon City, Philippines
Clinical Study Site #2
Quezon City, Philippines
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Dąbrowa Górnicza, Poland
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Gdynia, Poland
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Krakow, Poland
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Lodz, Poland
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Olsztyn, Poland
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Poznan, Poland
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Prabuty, Poland
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Radom, Poland
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Rzeszów, Poland
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Torun, Poland
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Warsaw, Poland
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Wodzisław Śląski, Poland
Clinical Study Site 1
Craiova, Romania
Clinical Study Site 2
Craiova, Romania
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Floreşti, Romania
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Ploieşti, Romania
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Timișoara, Romania
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Ufa, Republic Bashkortost, Russia
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Pushkin, Sankt-Peterburg, Russia
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Arkhangelsk, Russia
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Belgorod, Russia
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Chelyabinsk, Russia
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Kaluga, Russia
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Kazan', Russia
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Kemerovo, Russia
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Kislino, Russia
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Kursk, Russia
Clinical Study Site 1
Moscow, Russia
Clinical Study Site 2
Moscow, Russia
Clinical Study Site 3
Moscow, Russia
Clinical Study Site
Omsk, Russia
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Pyatigorsk, Russia
Clinical Study Site 1
Saint Petersburg, Russia
Clinical Study Site 2
Saint Petersburg, Russia
Clinical Study Site 3
Saint Petersburg, Russia
Clinical Study Site 4
Saint Petersburg, Russia
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Samara, Russia
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Saransk, Russia
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Sochi, Russia
Clinical Study Site 1
Tomsk, Russia
Clinical Study Site 2
Tomsk, Russia
Clinical Study Site
Yekaterinburg, Russia
Clinical Study Site
Manresa, Barcelona, Spain
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Barcelona, Spain
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Pamplona, Spain
Clinical Study Site
Chang-hua, Taiwan
Clinical Study Site
Hualien City, Taiwan
Clinical Study Site 1
Kaohsiung City, Taiwan
Clinical Study Site 2
Kaohsiung City, Taiwan
Clinical Study Site 1
New Taipei City, Taiwan
Clinical Study Site 2
New Taipei City, Taiwan
Clinical Study Site 1
Taichung, Taiwan
Clinical Study Site 2
Taichung, Taiwan
Clinical Study Site 1
Taipei, Taiwan
Clinical Study Site 2
Taipei, Taiwan
Clinical Study Site 3
Taipei, Taiwan
Clinical Study Site
Hat Yai, Changwat Songkhla, Thailand
Clinical Study Site
Lopburi, Muang, Thailand
Clinical Study Site #1
Bangkok, Thailand
Clinical Study Site #2
Bangkok, Thailand
Clinical Study Site
Chiang Rai, Thailand
Clinical Study Site
Khon Kaen, Thailand
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Lampang, Thailand
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Phitsanulok, Thailand
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Ratchathewi, Thailand
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Udon Thani, Thailand
Clinical Study Site 1
Adana, Turkey (Türkiye)
Clinical Study Site 2
Adana, Turkey (Türkiye)
Clinical Study Site 1
Ankara, Turkey (Türkiye)
Clinical Study Site 2
Ankara, Turkey (Türkiye)
Clinical Study Site 3
Ankara, Turkey (Türkiye)
Clinical Study Site 4
Ankara, Turkey (Türkiye)
Clinical Study Site 5
Ankara, Turkey (Türkiye)
Clinical Study Site
Edirne, Turkey (Türkiye)
Clinical Study Site 1
Istanbul, Turkey (Türkiye)
Clinical Study Site 2
Istanbul, Turkey (Türkiye)
Clinical Study Site 3
Istanbul, Turkey (Türkiye)
Clinical Study Site 4
Istanbul, Turkey (Türkiye)
Clinical Study Site 1
Izmir, Turkey (Türkiye)
Clinical Study Site 2
Izmir, Turkey (Türkiye)
Clinical Study Site 3
Izmir, Turkey (Türkiye)
Clinical Study Site
Samsun, Turkey (Türkiye)
Clinical Study Site
Dnipro, Ukraine
Clinical Study Site
Ivano-Frankivsk, Ukraine
Clinical Study Site
Kharkiv, Ukraine
Clinical Study Site
Kherson, Ukraine
Clinical Study Site 1
Kiev, Ukraine
Clinical Study Site 2
Kiev, Ukraine
Clinical Study Site
Kirovohrad, Ukraine
Clinical Study Site 1
Kyiv, Ukraine
Clinical Study Site 2
Kyiv, Ukraine
Clinical Study Site
Uzhhorod, Ukraine
Clinical Study Site
Vinnytsia, Ukraine
Clinical Study Site
Zaporizhzhya, Ukraine
Related Publications (5)
Gandara DR, Gumus M, Kilickap S, Sezer A, Bondarenko I, Ozguroglu M, Gogishvili M, Yan E, Jia X, Kim E, Seebach F, Quek RGW. Review of patient-reported outcomes in EMPOWER-Lung 1 in patients with advanced non-small cell lung cancer treated with cemiplimab versus chemotherapy. Cancer. 2026 Mar 15;132(6):e70339. doi: 10.1002/cncr.70339.
PMID: 41808570DERIVEDPerez J, Kerr KM, Baker B, Fang F, Li J, McDonald J, Li S, Gao B, Pouliot JF, Seebach F, Lowy I, Gullo G, Herman G, Hamilton J, Rietschel P, McGuire K. Clinical Interchangeability of PD-L1 Immunohistochemistry Assays in First-Line Non-Small Cell Lung Cancer Management With Cemiplimab. JCO Precis Oncol. 2025 Sep;9:e2500177. doi: 10.1200/PO-25-00177. Epub 2025 Sep 24.
PMID: 40991883DERIVEDOzguroglu M, Kilickap S, Sezer A, Gumus M, Bondarenko I, Gogishvili M, Nechaeva M, Schenker M, Cicin I, Ho GF, Kulyaba Y, Zyuhal K, Scheusan RI, Garassino MC, He X, Kaul M, Okoye E, Li Y, Li S, Pouliot JF, Seebach F, Lowy I, Gullo G, Rietschel P. First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 Sep;24(9):989-1001. doi: 10.1016/S1470-2045(23)00329-7. Epub 2023 Aug 14.
PMID: 37591293DERIVEDGumus M, Chen CI, Ivanescu C, Kilickap S, Bondarenko I, Ozguroglu M, Gogishvili M, Turk HM, Cicin I, Harnett J, Mastey V, Naumann U, Reaney M, Konidaris G, Sasane M, Brady KJS, Li S, Gullo G, Rietschel P, Sezer A. Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of >/=50%: The EMPOWER-Lung 1 study. Cancer. 2023 Jan 1;129(1):118-129. doi: 10.1002/cncr.34477. Epub 2022 Oct 29.
PMID: 36308296DERIVEDSezer A, Kilickap S, Gumus M, Bondarenko I, Ozguroglu M, Gogishvili M, Turk HM, Cicin I, Bentsion D, Gladkov O, Clingan P, Sriuranpong V, Rizvi N, Gao B, Li S, Lee S, McGuire K, Chen CI, Makharadze T, Paydas S, Nechaeva M, Seebach F, Weinreich DM, Yancopoulos GD, Gullo G, Lowy I, Rietschel P. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021 Feb 13;397(10274):592-604. doi: 10.1016/S0140-6736(21)00228-2.
PMID: 33581821DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2017
First Posted
March 23, 2017
Study Start
May 29, 2017
Primary Completion
April 18, 2025
Study Completion
April 18, 2025
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
- Access Criteria
- Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing