Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

Last updated: April 30, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Carcinoma

Treatment

Cisplatin

Carboplatin

Gemcitabine

Clinical Study ID

NCT03088540
R2810-ONC-1624
2016-004407-31
2024-511454-45-00
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

A patient must meet the following criteria to be eligible for inclusion in the study:

  1. Patients with histologically or cytologically documented squamous or non squamousNSCLC with stage IIIB or stage IIIC disease who are not candidates for treatmentwith definitive concurrent chemoradiation or patients with stage IV disease whoreceived no prior systemic treatment for recurrent or metastatic NSCLC

  2. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrentsite, which has not previously been irradiated

  3. Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHCperformed 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

Key Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

  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 genetranslocations, or ROS1 fusions

  4. Encephalitis, meningitis, or uncontrolled seizures in the year prior torandomization

  5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizingpneumonia) or active, noninfectious pneumonitis that required immune-suppressivedoses of glucocorticoids to assist with management. A history of radiationpneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6months prior to randomization

  6. Patients with active, known, or suspected autoimmune disease that has requiredsystemic therapy in the past 2 years

  7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day orequivalent) 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 immunodeficiencyvirus (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 antibodytreatments

  17. Known psychiatric or substance abuse disorder that would interfere withparticipation with the requirements of the study, including current use of anyillicit drugs

  18. Pregnant or breastfeeding women

  19. Women of childbearing potential or men who are unwilling to practice highlyeffective contraception prior to the initial dose/start of the first treatment,during the study, and for at least 6 months after the last dose

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 712
Treatment Group(s): 6
Primary Treatment: Cisplatin
Phase: 3
Study Start date:
May 29, 2017
Estimated Completion Date:
April 18, 2025

Study Description

There is option to join genomics sub-study.

Connect with a study center

  • Clinical Study Site

    Albury, New South Wales
    Australia

    Site Not Available

  • Clinical Study Site

    Wollongong, New South Wales
    Australia

    Site Not Available

  • Clinical Study Site

    Fitzroy,
    Australia

    Site Not Available

  • Clinical Study Site

    Minsk,
    Belarus

    Site Not Available

  • Clinical Study Site

    Mogilev,
    Belarus

    Site Not Available

  • Clinical Study Site 1

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Clinical Study Site

    Barretos,
    Brazil

    Site Not Available

  • Clinical Study Site

    Curitiba,
    Brazil

    Site Not Available

  • Clinical Study Site

    Joinville,
    Brazil

    Site Not Available

  • Clinical Study Site

    Lajeado,
    Brazil

    Site Not Available

  • Clinical Study Site

    Mogi Das Cruzes,
    Brazil

    Site Not Available

  • Clinical Study Site

    Passo Fundo,
    Brazil

    Site Not Available

  • Clinical Study Site

    Pelotas,
    Brazil

    Site Not Available

  • Clinical Study Site 2

    Porto Alegre,
    Brazil

    Site Not Available

  • Clinical Study Site 3

    Porto Alegre,
    Brazil

    Site Not Available

  • Clinical Study Site

    Recife,
    Brazil

    Site Not Available

  • Clinical Study Site

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Clinical Study Site

    Salvador,
    Brazil

    Site Not Available

  • Clinical Study Site

    Santa Cecília,
    Brazil

    Site Not Available

  • Clinical Study Site #4

    Sao Paulo,
    Brazil

    Site Not Available

  • Clinical Study Site

    São José Do Rio Preto,
    Brazil

    Site Not Available

  • Clinical Study Site #3

    São Paulo,
    Brazil

    Site Not Available

  • Clinical Study Site 1

    São Paulo,
    Brazil

    Site Not Available

  • Clinical Study Site 2

    São Paulo,
    Brazil

    Site Not Available

  • Clinical Study Site

    Dobrich,
    Bulgaria

    Site Not Available

  • Clinical Study Site

    Gabrovo,
    Bulgaria

    Site Not Available

  • Clinical Study Site

    Recoleta,
    Chile

    Site Not Available

  • Clinical Study Site

    Santiago,
    Chile

    Site Not Available

  • Clinical Study Site

    Temuco,
    Chile

    Site Not Available

  • Clincial Study Site

    Viña Del Mar,
    Chile

    Site Not Available

  • Clinical Study Site

    Lanshan, Shandong
    China

    Site Not Available

  • Clinical Study Site

    Guangdong,
    China

    Site Not Available

  • Clinical Study Site

    Harbin,
    China

    Site Not Available

  • Clinical Study Site

    Linyi,
    China

    Site Not Available

  • Clinical Study Site 1

    Shanghai,
    China

    Site Not Available

  • Clinical Study Site 2

    Shanghai,
    China

    Site Not Available

  • Clinical Study Site 1

    Tianjin,
    China

    Site Not Available

  • Clinical Study Site 2

    Tianjin,
    China

    Site Not Available

  • Clinical Study Site

    Xuzhou,
    China

    Site Not Available

  • Clinical Study Site

    Zhejiang,
    China

    Site Not Available

  • Clinical Study Site

    Barranquilla,
    Colombia

    Site Not Available

  • Clinical Study Site

    Bogotá,
    Colombia

    Site Not Available

  • Clinical Study Site

    Floridablanca,
    Colombia

    Site Not Available

  • Clinical Study Site

    Nový Jičín,
    Czechia

    Site Not Available

  • Clinical Study Site

    Pelhřimov,
    Czechia

    Site Not Available

  • Clinical Study Site

    Prague,
    Czechia

    Site Not Available

  • Clinical Study Site

    Praha,
    Czechia

    Site Not Available

  • Clinical Study Site

    Batumi,
    Georgia

    Site Not Available

  • Clinical Study Site #6

    Tbilisi,
    Georgia

    Site Not Available

  • Clinical Study Site 1

    Tbilisi,
    Georgia

    Site Not Available

  • Clinical Study Site 2

    Tbilisi,
    Georgia

    Site Not Available

  • Clinical Study Site 3

    Tbilisi,
    Georgia

    Site Not Available

  • Clinical Study Site 4

    Tbilisi,
    Georgia

    Site Not Available

  • Clinical Study Site 5

    Tbilisi,
    Georgia

    Site Not Available

  • Clinical Study Site

    Patras, Achaia
    Greece

    Site Not Available

  • Clinical Study Site

    Cholargós, Attiki
    Greece

    Site Not Available

  • Clinical Study Site 1

    Athens,
    Greece

    Site Not Available

  • Clinical Study Site 2

    Athens,
    Greece

    Site Not Available

  • Clinical Study Site 3

    Athens,
    Greece

    Site Not Available

  • Clinical Study Site

    Larissa,
    Greece

    Site Not Available

  • Clinical Study Site

    Pylaía,
    Greece

    Site Not Available

  • Clinical Study Site 1

    Thessaloníki,
    Greece

    Site Not Available

  • Clinical Study Site 2

    Thessaloníki,
    Greece

    Site Not Available

  • Clinical Study Site 3

    Thessaloníki,
    Greece

    Site Not Available

  • Clinical Study Site

    Gyula, Bekes
    Hungary

    Site Not Available

  • Clinical Study Site

    Tatabánya, Komarom-Esztergom
    Hungary

    Site Not Available

  • Clinical Study Site

    Farkasgyepű, Veszprém
    Hungary

    Site Not Available

  • Clinical Study Site

    Budapest,
    Hungary

    Site Not Available

  • Clinical Study Site

    Debrecen,
    Hungary

    Site Not Available

  • Clinical Study Site

    Zalaegerszeg,
    Hungary

    Site Not Available

  • Clinical Study Site

    Amman,
    Jordan

    Site Not Available

  • Clinical Study Site

    Irbid,
    Jordan

    Site Not Available

  • Clinical Study Site

    Bsalîm,
    Lebanon

    Site Not Available

  • Clinical Study Site

    Mazraat Ech Choûf,
    Lebanon

    Site Not Available

  • Clinical Study Site

    Sidon,
    Lebanon

    Site Not Available

  • Clinical Study Site

    Kampung Baharu Nilai,
    Malaysia

    Site Not Available

  • Clinical Study Site #1

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Clinical Study Site #2

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Clinical Study Site

    Kuching,
    Malaysia

    Site Not Available

  • Clinical Study Site

    Pulau Pinang,
    Malaysia

    Site Not Available

  • Clinical Study Site

    Tanjong Bungah,
    Malaysia

    Site Not Available

  • Clinical Study Site

    Coahuila,
    Mexico

    Site Not Available

  • Clinical Study Site

    Cuautitlán,
    Mexico

    Site Not Available

  • Clinical Study Site

    Jalisco,
    Mexico

    Site Not Available

  • Clinical Study Site

    León de los Aldama,
    Mexico

    Site Not Available

  • Clinical Study Site 1

    Monterrey,
    Mexico

    Site Not Available

  • Clinical Study Site 2

    Monterrey,
    Mexico

    Site Not Available

  • Clinical Study Site 3

    Monterrey,
    Mexico

    Site Not Available

  • Clinical Study Site

    Oaxaca,
    Mexico

    Site Not Available

  • Clinical Study Site

    San Luis Potosí,
    Mexico

    Site Not Available

  • Clinical Study Site

    Bacolod City,
    Philippines

    Site Not Available

  • Clinical Study Site

    Batangas,
    Philippines

    Site Not Available

  • Clinical Study Site

    Cebu,
    Philippines

    Site Not Available

  • Clinical Study Site

    Davao City,
    Philippines

    Site Not Available

  • Clinical Study Site 1

    Manila,
    Philippines

    Site Not Available

  • Clinical Study Site 2

    Manila,
    Philippines

    Site Not Available

  • Clinical Study Site #1

    Quezon City,
    Philippines

    Site Not Available

  • Clinical Study Site #2

    Quezon City,
    Philippines

    Site Not Available

  • Clinical Study Site

    Taguig,
    Philippines

    Site Not Available

  • Clinical Study Site

    Dąbrowa Górnicza,
    Poland

    Site Not Available

  • Clinical Study Site

    Gdynia,
    Poland

    Site Not Available

  • Clinical Study Site

    Kraków,
    Poland

    Site Not Available

  • Clinical Study Site

    Olsztyn,
    Poland

    Site Not Available

  • Clinical Study Site

    Poznań,
    Poland

    Site Not Available

  • Clinical Study Site

    Prabuty,
    Poland

    Site Not Available

  • Clinical Study Site

    Radom,
    Poland

    Site Not Available

  • Clinical Study Site

    Rzeszów,
    Poland

    Site Not Available

  • Clinical Study Site

    Toruń,
    Poland

    Site Not Available

  • Clinical Study Site

    Warszawa,
    Poland

    Site Not Available

  • Clinical Study Site

    Wodzisław Śląski,
    Poland

    Site Not Available

  • Clinical Study Site

    Łódź,
    Poland

    Site Not Available

  • Clinical Study Site 1

    Craiova,
    Romania

    Site Not Available

  • Clinical Study Site 2

    Craiova,
    Romania

    Site Not Available

  • Clinical Study Site

    Floreşti,
    Romania

    Site Not Available

  • Clinical Study Site

    Ploieşti,
    Romania

    Site Not Available

  • Clinical Study Site

    Timişoara,
    Romania

    Site Not Available

  • Clinical Study Site

    Ufa, Republic Bashkortost
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Pushkin, Saint Petersburg
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Arkhangel'sk,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Belgorod,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Chelyabinsk,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Kaluga,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Kazan,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Kemerovo,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Kislino,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Kursk,
    Russian Federation

    Site Not Available

  • Clinical Study Site 1

    Moscow,
    Russian Federation

    Site Not Available

  • Clinical Study Site 2

    Moscow,
    Russian Federation

    Site Not Available

  • Clinical Study Site 3

    Moscow,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Omsk,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Pyatigorsk,
    Russian Federation

    Site Not Available

  • Clinical Study Site 1

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Clinical Study Site 2

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Clinical Study Site 3

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Clinical Study Site 4

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Samara,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Saransk,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Sochi,
    Russian Federation

    Site Not Available

  • Clinical Study Site 1

    Tomsk,
    Russian Federation

    Site Not Available

  • Clinical Study Site 2

    Tomsk,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Yekaterinburg,
    Russian Federation

    Site Not Available

  • Clinical Study Site

    Manresa, Barcelona
    Spain

    Site Not Available

  • Clinical Study Site

    Barcelona,
    Spain

    Site Not Available

  • Clinical Study Site

    Pamplona,
    Spain

    Site Not Available

  • Clinical Study Site

    Chang Hua,
    Taiwan

    Site Not Available

  • Clinical Study Site

    Hualien City,
    Taiwan

    Site Not Available

  • Clinical Study Site 1

    Kaohsiung,
    Taiwan

    Site Not Available

  • Clinical Study Site 2

    Kaohsiung,
    Taiwan

    Site Not Available

  • Clinical Study Site 2

    New Taipei,
    Taiwan

    Site Not Available

  • Clinical Study Site 1

    New Taipei City,
    Taiwan

    Site Not Available

  • Clinical Study Site 1

    Taichung,
    Taiwan

    Site Not Available

  • Clinical Study Site 2

    Taichung,
    Taiwan

    Site Not Available

  • Clinical Study Site 1

    Taipei,
    Taiwan

    Site Not Available

  • Clinical Study Site 2

    Taipei,
    Taiwan

    Site Not Available

  • Clinical Study Site 3

    Taipei,
    Taiwan

    Site Not Available

  • Clinical Study Site

    Lop Buri, Muang
    Thailand

    Site Not Available

  • Clinical Study Site

    Hat Yai, Songkhla
    Thailand

    Site Not Available

  • Clinical Study Site #1

    Bangkok,
    Thailand

    Site Not Available

  • Clinical Study Site #2

    Bangkok,
    Thailand

    Site Not Available

  • Clinical Study Site

    Chiang Rai,
    Thailand

    Site Not Available

  • Clinical Study Site

    Khon Kaen,
    Thailand

    Site Not Available

  • Clinical Study Site

    Lampang,
    Thailand

    Site Not Available

  • Clinical Study Site

    Phitsanulok,
    Thailand

    Site Not Available

  • Clinical Study Site

    Ratchathewi,
    Thailand

    Site Not Available

  • Clinical Study Site

    Udon Thani,
    Thailand

    Site Not Available

  • Clinical Study Site 1

    Adana,
    Turkey

    Site Not Available

  • Clinical Study Site 2

    Adana,
    Turkey

    Site Not Available

  • Clinical Study Site 1

    Ankara,
    Turkey

    Site Not Available

  • Clinical Study Site 2

    Ankara,
    Turkey

    Site Not Available

  • Clinical Study Site 3

    Ankara,
    Turkey

    Site Not Available

  • Clinical Study Site 4

    Ankara,
    Turkey

    Site Not Available

  • Clinical Study Site 5

    Ankara,
    Turkey

    Site Not Available

  • Clinical Study Site

    Edirne,
    Turkey

    Site Not Available

  • Clinical Study Site 1

    Istanbul,
    Turkey

    Site Not Available

  • Clinical Study Site 2

    Istanbul,
    Turkey

    Site Not Available

  • Clinical Study Site 3

    Istanbul,
    Turkey

    Site Not Available

  • Clinical Study Site 4

    Istanbul,
    Turkey

    Site Not Available

  • Clinical Study Site

    Samsun,
    Turkey

    Site Not Available

  • Clinical Study Site 1

    İzmir,
    Turkey

    Site Not Available

  • Clinical Study Site 2

    İzmir,
    Turkey

    Site Not Available

  • Clinical Study Site 3

    İzmir,
    Turkey

    Site Not Available

  • Clinical Study Site

    Dnepropetrovsk,
    Ukraine

    Site Not Available

  • Clinical Study Site

    Ivano-Frankivs'k,
    Ukraine

    Site Not Available

  • Clinical Study Site

    Kharkiv,
    Ukraine

    Site Not Available

  • Clinical Study Site

    Kherson,
    Ukraine

    Site Not Available

  • Clinical Study Site 1

    Kiev,
    Ukraine

    Site Not Available

  • Clinical Study Site 2

    Kiev,
    Ukraine

    Site Not Available

  • Clinical Study Site

    Kirovohrad,
    Ukraine

    Site Not Available

  • Clinical Study Site 1

    Kyiv,
    Ukraine

    Site Not Available

  • Clinical Study Site 2

    Kyiv,
    Ukraine

    Site Not Available

  • Clinical Study Site

    Vinnytsia,
    Ukraine

    Site Not Available

  • Clinical Study Site

    Zaporozhye,
    Ukraine

    Site Not Available

  • Clinical Study Site

    Úzhgorod,
    Ukraine

    Site Not Available

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