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NCT03088540

PHASE3

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

712

Start Date

2017-05-29

Completion Date

2025-04-18

Last Updated

2026-06-25

Healthy Volunteers

Conditions

Carcinoma，Non-Small-Cell Lung Lung Carcinomas, Non-Small-Cell Non-small-cell Lung Carcinoma Nonsmall Cell Lung Cancer

Interventions

DRUG

Pemetrexed

Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin

DRUG

Paclitaxel

Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin

DRUG

Gemcitabine

Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin

DRUG

Cisplatin

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

DRUG

Carboplatin

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

DRUG

cemiplimab

Patients will be administered cemiplimab as per protocol.

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 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 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 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 Note: Other protocol defined Inclusion/Exclusion criteria apply.

Locations (192)

Clinical Study Site

Albury, New South Wales, Australia

Clinical Study Site

Wollongong, New South Wales, Australia

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Fitzroy, Australia

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Minsk, Belarus

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Mogilev, Belarus

Clinical Study Site 1

Porto Alegre, Rio Grande do Sul, Brazil

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Barretos, Brazil

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Curitiba, Brazil

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Joinville, Brazil

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Lajeado, Brazil

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Mogi das Cruzes, Brazil

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Passo Fundo, Brazil

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Pelotas, Brazil

Clinical Study Site 2

Porto Alegre, Brazil

Clinical Study Site 3

Porto Alegre, Brazil

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Recife, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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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

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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

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Tianjin, China

Clinical Study Site 2

Tianjin, China

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Xuzhou, China

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Zhejiang, China

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Barranquilla, Colombia

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Bogotá, Colombia

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Floridablanca, Colombia

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Nový Jičín, Czechia

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Pelhřimov, Czechia

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Prague, Czechia

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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

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Pátrai, Achaia, Greece

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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

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Gyula, Bekes County, Hungary

Clinical Study Site

Tatabánya, Komárom-Esztergom, Hungary

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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

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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

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Yekaterinburg, Russia

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Manresa, Barcelona, Spain

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Barcelona, Spain

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Pamplona, Spain

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Chang-hua, Taiwan

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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

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Chiang Rai, Thailand

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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)

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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)

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Samsun, Turkey (Türkiye)

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Dnipro, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kherson, Ukraine

Clinical Study Site 1

Kiev, Ukraine

Clinical Study Site 2

Kiev, Ukraine

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Kirovohrad, Ukraine

Clinical Study Site 1

Kyiv, Ukraine

Clinical Study Site 2

Kyiv, Ukraine

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Uzhhorod, Ukraine

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Vinnytsia, Ukraine

Clinical Study Site

Zaporizhzhya, Ukraine

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (192)