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Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
Sponsor: Regeneron Pharmaceuticals
Summary
The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. The key secondary objectives are: Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
Official title: A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
789
Start Date
2018-03-06
Completion Date
2025-02-27
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
REGN2810/chemo/ipi
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
Chemotherapy
Platinum-based doublet chemotherapy Part 1
Placebo
Matching placebo Part 2
Locations (133)
Regeneron Research Site
Rancho Mirage, California, United States
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Riverside, California, United States
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Whittier, California, United States
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Orange City, Florida, United States
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St. Petersburg, Florida, United States
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Wichita, Kansas, United States
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Bethesda, Maryland, United States
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Farmington, New Mexico, United States
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Gettysburg, Pennsylvania, United States
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Vienna, Austria
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Baoding, China
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Beijing, China
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Changsha, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Jinan, China
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Linyi, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Xiangyang, China
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Zhengzhou, China
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Zhengzhou, China
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Bayonne, France
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Créteil, France
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Le Mans, France
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Lille, France
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Lyon, France
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Mont-de-Marsan, France
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Saint-Herblain, France
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Saint-Mandé, France
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Strasbourg, France
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Batumi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
Regeneron Research Site #1
Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Thessaloniki, Macedonia, Greece
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Athens, Greece
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Kifissia, Greece
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Larissa, Greece
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Pylaia, Greece
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Thessaloniki, Greece
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Dublin, Ireland
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Limerick, Ireland
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Cremona, Italy
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Meldola, Italy
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Milan, Italy
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Monserrato, Italy
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Piacenza, Italy
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Saronno, Italy
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Terni, Italy
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Treviglio, Italy
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Kuala Lumpur, Kuala Lumpur, Malaysia
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George Town, Malaysia
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Johor Bahru, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Kuala Lumpur, Malaysia
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Kuantan, Malaysia
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Pulau Pinang, Malaysia
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Tanjung Bungah, Malaysia
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Gdynia, Pomeranian Voivodeship, Poland
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Lodz, Poland
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Lublin, Poland
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Olsztyn, Poland
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Otwock, Poland
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Poznan, Poland
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Rzeszów, Poland
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Torun, Poland
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Wodzisław Śląski, Poland
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Cluj-Napoca, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Craiova, Romania
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Craiova, Romania
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Ufa, Republic Bashkortost, 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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Kursk, Russia
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Moscow, Russia
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Moscow, Russia
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Moscow Region, Russia
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Omsk, Russia
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Pushkin, Russia
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Pyatigorsk, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saransk, Russia
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Sochi, Russia
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Tomsk, Russia
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Tomsk, Russia
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Yekaterinburg, Russia
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Banka, Slovakia
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Cheongju-si, South Korea
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Incheon, South Korea
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Jeonju, South Korea
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Seongnam-si, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Suwon, South Korea
Regeneron Research Site #2
Ratchathewi, Bangkok, Thailand
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Muang, Changwat Chiang Rai, Thailand
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A. Mueang, Changwat Lampang, Thailand
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Muang, Changwat Phitsanulok, Thailand
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Hat Yai, Changwat Songkhla, Thailand
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Udon Thani, Udonthani, Thailand
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Muang, Thailand
Regeneron Research Site #1
Ratchathewi, Thailand
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Dnipro, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kirovohrad, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine