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COMPLETED
NCT03409614
PHASE3

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

REGN2810

REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2

DRUG

REGN2810/chemo/ipi

REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1

OTHER

Chemotherapy

Platinum-based doublet chemotherapy Part 1

DRUG

Placebo

Matching placebo Part 2

Locations (133)

Regeneron Research Site

Rancho Mirage, California, United States

Regeneron Research Site

Riverside, California, United States

Regeneron Research Site

Whittier, California, United States

Regeneron Research Site

Orange City, Florida, United States

Regeneron Research Site

St. Petersburg, Florida, United States

Regeneron Research Site

Wichita, Kansas, United States

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Bethesda, Maryland, United States

Regeneron Research Site

Farmington, New Mexico, United States

Regeneron Research Site

Gettysburg, Pennsylvania, United States

Regeneron Research Site

Vienna, Austria

Regeneron Research Site

Baoding, China

Regeneron research Site

Beijing, China

Regeneron Research Site

Changsha, China

Regeneron Research Site

Guangzhou, China

Regeneron Research Site

Hangzhou, China

Regeneron Research Site

Hangzhou, China

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Hangzhou, China

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Hangzhou, China

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Jinan, China

Regeneron Research Site

Linyi, China

Regeneron Research Site

Nanjing, China

Regeneron Research Site

Shanghai, China

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Shanghai, China

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Shenyang, China

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Xiangyang, China

Regeneron Research Site

Zhengzhou, China

Regeneron Research Site

Zhengzhou, China

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Bayonne, France

Regeneron Research Site

Créteil, France

Regeneron Research Site

Le Mans, France

Regeneron Research Site

Lille, France

Regeneron Research Site

Lyon, France

Regeneron Research Site

Mont-de-Marsan, France

Regeneron Research Site

Saint-Herblain, France

Regeneron Research Site

Saint-Mandé, France

Regeneron Research Site

Strasbourg, France

Regeneron Research Site

Batumi, Georgia

Regeneron Research Site

Tbilisi, Georgia

Regeneron Research Site

Tbilisi, Georgia

Regeneron Research Site #1

Tbilisi, Georgia

Regeneron Research Site #2

Tbilisi, Georgia

Regeneron Research Site

Tbilisi, Georgia

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Thessaloniki, Macedonia, Greece

Regeneron Research Site

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

Regeneron Research Site

Vilnius, Lithuania

Regeneron Research Site

Kuala Lumpur, Kuala Lumpur, Malaysia

Regeneron Research Site

George Town, Malaysia

Regeneron Research Site

Johor Bahru, Malaysia

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Kota Kinabalu, Malaysia

Regeneron Research Site

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

Regeneron Research Site

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

Regeneron Research Site

Cluj-Napoca, Romania

Regeneron Research Site

Cluj-Napoca, Romania

Regeneron Research Site

Craiova, Romania

Regeneron Research Site

Craiova, Romania

Regeneron Research Site

Craiova, Romania

Regeneron Research Site

Ufa, Republic Bashkortost, Russia

Regeneron Research Site

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

Regeneron Research Site

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

Regeneron Research Site

Cheongju-si, South Korea

Regeneron Research Site

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

Regeneron Research Site

Seoul, South Korea

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Seoul, South Korea

Regeneron Research Site

Seoul, South Korea

Regeneron Research Site

Suwon, South Korea

Regeneron Research Site #2

Ratchathewi, Bangkok, Thailand

Regeneron Research Site

Muang, Changwat Chiang Rai, Thailand

Regeneron Research Site

A. Mueang, Changwat Lampang, Thailand

Regeneron Research Site

Muang, Changwat Phitsanulok, Thailand

Regeneron Research Site

Hat Yai, Changwat Songkhla, Thailand

Regeneron Research Site

Udon Thani, Udonthani, Thailand

Regeneron Research Site

Muang, Thailand

Regeneron Research Site #1

Ratchathewi, Thailand

Regeneron Research Site

Adana, Turkey (Türkiye)

Regeneron Research Site

Ankara, Turkey (Türkiye)

Regeneron Research Site

Istanbul, Turkey (Türkiye)

Regeneron Research Site

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

Regeneron Research Site

Vinnytsia, Ukraine