Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT03088540
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
712 participants
INTERVENTIONAL
2017-05-29
2025-04-18
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Standard-of-care chemotherapy
Standard-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
Pemetrexed
Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
Paclitaxel
Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
Gemcitabine
Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
Cisplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Carboplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
cemiplimab
cemiplimab regimen as monotherapy as per study protocol
cemiplimab
Patients will be administered cemiplimab as per protocol.
Interventions
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Pemetrexed
Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
Paclitaxel
Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
Gemcitabine
Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
Cisplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Carboplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
cemiplimab
Patients will be administered cemiplimab as per protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 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
2. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
3. Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
4. At least 1 radiographically measureable lesion per RECIST 1.1
5. ECOG performance status of ≤1
6. Anticipated life expectancy of at least 3 months
7. Adequate organ and bone marrow function
Exclusion Criteria
1. Patients that have never smoked, defined as smoking \<100 cigarettes in a lifetime
2. Active or untreated brain metastases or spinal cord compression
3. Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
5. 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
6. Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
7. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization
8. Another malignancy that is progressing or requires treatment
9. Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
10. Active infection requiring systemic therapy within 14 days prior to randomization
11. Prior therapy with anti-PD 1 or anti-PD L1
12. Treatment-related immune-mediated AEs from immune-modulatory agents
13. Receipt of an investigational drug or device within 30 days
14. Receipt of a live vaccine within 30 days of planned start of study medication
15. Major surgery or significant traumatic injury within 4 weeks prior to first dose
16. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
17. Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
18. Pregnant or breastfeeding women
19. 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
Clinical Study Site
Lajeado, , Brazil
Clinical Study Site
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
Clinical Study Site
Rio de Janeiro, , Brazil
Clinical Study Site
Salvador, , Brazil
Clinical Study Site
Santa Cecília, , Brazil
Clinical Study Site
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
Clinical Study Site
Gabrovo, , Bulgaria
Clinical Study Site
Recoleta, , Chile
Clinical Study Site
Santiago, , Chile
Clinical Study Site
Temuco, , Chile
Clincial Study Site
Viña del Mar, , Chile
Clinical Study Site
Lanshan, Shandong, China
Clinical Study Site
Guangdong, , China
Clinical Study Site
Harbin, , China
Clinical Study Site
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
Clinical Study Site
Xuzhou, , China
Clinical Study Site
Zhejiang, , China
Clinical Study Site
Barranquilla, , Colombia
Clinical Study Site
Bogotá, , Colombia
Clinical Study Site
Floridablanca, , Colombia
Clinical Study Site
Nový Jičín, , Czechia
Clinical Study Site
Pelhřimov, , Czechia
Clinical Study Site
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
Clinical Study Site
Larissa, , Greece
Clinical Study Site
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
Clinical Study Site
Budapest, , Hungary
Clinical Study Site
Debrecen, , Hungary
Clinical Study Site
Zalaegerszeg, , Hungary
Clinical Study Site
Amman, , Jordan
Clinical Study Site
Irbid, , Jordan
Clinical Study Site
Bsalîm, , Lebanon
Clinical Study Site
Mazraat ech Choûf, , Lebanon
Clinical Study Site
Sidon, , Lebanon
Clinical Study Site
Kampung Baharu Nilai, , Malaysia
Clinical Study Site #1
Kuala Lumpur, , Malaysia
Clinical Study Site #2
Kuala Lumpur, , Malaysia
Clinical Study Site
Kuching, , Malaysia
Clinical Study Site
Pulau Pinang, , Malaysia
Clinical Study Site
Tanjong Bungah, , Malaysia
Clinical Study Site
Coahuila, , Mexico
Clinical Study Site
Cuautitlán, , Mexico
Clinical Study Site
Jalisco, , Mexico
Clinical Study Site
León, , Mexico
Clinical Study Site 1
Monterrey, , Mexico
Clinical Study Site 2
Monterrey, , Mexico
Clinical Study Site 3
Monterrey, , Mexico
Clinical Study Site
Oaxaca City, , Mexico
Clinical Study Site
San Luis Potosí City, , Mexico
Clinical Study Site
Bacolod City, , Philippines
Clinical Study Site
Batangas, , Philippines
Clinical Study Site
Cebu, , Philippines
Clinical Study Site
City of Taguig, , Philippines
Clinical Study Site
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
Clinical Study Site
Dąbrowa Górnicza, , Poland
Clinical Study Site
Gdynia, , Poland
Clinical Study Site
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
Clinical Study Site
Wodzisław Śląski, , Poland
Clinical Study Site 1
Craiova, , Romania
Clinical Study Site 2
Craiova, , Romania
Clinical Study Site
Floreşti, , Romania
Clinical Study Site
Ploieşti, , Romania
Clinical Study Site
Timișoara, , Romania
Clinical Study Site
Ufa, Republic Bashkortost, Russia
Clinical Study Site
Pushkin, Sankt-Peterburg, Russia
Clinical Study Site
Arkhangelsk, , Russia
Clinical Study Site
Belgorod, , Russia
Clinical Study Site
Chelyabinsk, , Russia
Clinical Study Site
Kaluga, , Russia
Clinical Study Site
Kazan', , Russia
Clinical Study Site
Kemerovo, , Russia
Clinical Study Site
Kislino, , Russia
Clinical Study Site
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
Clinical Study Site
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
Clinical Study Site
Samara, , Russia
Clinical Study Site
Saransk, , Russia
Clinical Study Site
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
Clinical Study Site
Barcelona, , Spain
Clinical Study Site
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
Clinical Study Site
Lampang, , Thailand
Clinical Study Site
Phitsanulok, , Thailand
Clinical Study Site
Ratchathewi, , Thailand
Clinical Study Site
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
Countries
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References
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Perez 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.
Ozguroglu 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.
Gumus 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.
Sezer 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.
Other Identifiers
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2016-004407-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511454-45-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R2810-ONC-1624
Identifier Type: -
Identifier Source: org_study_id
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