Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
May 29, 2026 updated by: Regeneron Pharmaceuticals
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is option to join genomics sub-study.
Study Type
Interventional
Enrollment (Actual)
712
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fitzroy, Australia
- Clinical Study Site
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New South Wales
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Albury, New South Wales, Australia
- Clinical Study Site
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Wollongong, New South Wales, Australia
- Clinical Study Site
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Minsk, Belarus
- Clinical Study Site
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Mogilev, Belarus
- Clinical Study Site
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Barretos, Brazil
- Clinical Study Site
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Curitiba, Brazil
- Clinical Study Site
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Joinville, Brazil
- Clinical Study Site
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Lajeado, Brazil
- Clinical Study Site
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Mogi das Cruzes, Brazil
- Clinical Study Site
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Passo Fundo, Brazil
- Clinical Study Site
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Pelotas, Brazil
- Clinical Study Site
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Porto Alegre, Brazil
- Clinical Study Site 2
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Porto Alegre, Brazil
- Clinical Study Site 3
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Recife, Brazil
- Clinical Study Site
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Rio de Janeiro, Brazil
- Clinical Study Site
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Salvador, Brazil
- Clinical Study Site
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Santa Cecília, Brazil
- Clinical Study Site
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São José do Rio Preto, Brazil
- Clinical Study Site
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São Paulo, Brazil
- Clinical Study Site #3
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São Paulo, Brazil
- Clinical Study Site 1
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São Paulo, Brazil
- Clinical Study Site 2
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São Paulo, Brazil
- Clinical Study Site #4
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil
- Clinical Study Site 1
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Dobrich, Bulgaria
- Clinical Study Site
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Gabrovo, Bulgaria
- Clinical Study Site
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Recoleta, Chile
- Clinical Study Site
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Santiago, Chile
- Clinical Study Site
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Temuco, Chile
- Clinical Study Site
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Viña del Mar, Chile
- Clincial Study Site
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Guangdong, China
- Clinical Study Site
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Harbin, China
- Clinical Study Site
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Linyi, China
- Clinical Study Site
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Shanghai, China
- Clinical Study Site 1
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Shanghai, China
- Clinical Study Site 2
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Tianjin, China
- Clinical Study Site 1
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Tianjin, China
- Clinical Study Site 2
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Xuzhou, China
- Clinical Study Site
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Zhejiang, China
- Clinical Study Site
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Shandong
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Lanshan, Shandong, China
- Clinical Study Site
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Barranquilla, Colombia
- Clinical Study Site
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Bogotá, Colombia
- Clinical Study Site
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Floridablanca, Colombia
- Clinical Study Site
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Nový Jičín, Czechia
- Clinical Study Site
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Pelhřimov, Czechia
- Clinical Study Site
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Prague, Czechia
- Clinical Study Site
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Batumi, Georgia
- Clinical Study Site
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Tbilisi, Georgia
- Clinical Study Site #6
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Tbilisi, Georgia
- Clinical Study Site 1
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Tbilisi, Georgia
- Clinical Study Site 2
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Tbilisi, Georgia
- Clinical Study Site 3
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Tbilisi, Georgia
- Clinical Study Site 4
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Tbilisi, Georgia
- Clinical Study Site 5
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Athens, Greece
- Clinical Study Site 1
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Athens, Greece
- Clinical Study Site 2
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Athens, Greece
- Clinical Study Site 3
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Larissa, Greece
- Clinical Study Site
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Pylaia, Greece
- Clinical Study Site
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Thessaloniki, Greece
- Clinical Study Site 1
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Thessaloniki, Greece
- Clinical Study Site 2
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Thessaloniki, Greece
- Clinical Study Site 3
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Achaia
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Pátrai, Achaia, Greece
- Clinical Study Site
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Attica
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Cholargós, Attica, Greece
- Clinical Study Site
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Budapest, Hungary
- Clinical Study Site
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Debrecen, Hungary
- Clinical Study Site
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Zalaegerszeg, Hungary
- Clinical Study Site
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Bekes County
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Gyula, Bekes County, Hungary
- Clinical Study Site
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Komárom-Esztergom
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Tatabánya, Komárom-Esztergom, Hungary
- Clinical Study Site
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Veszprém megye
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Farkasgyepű, Veszprém megye, Hungary
- Clinical Study Site
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Amman, Jordan
- Clinical Study Site
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Irbid, Jordan
- Clinical Study Site
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Bsalîm, Lebanon
- Clinical Study Site
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Mazraat ech Choûf, Lebanon
- Clinical Study Site
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Sidon, Lebanon
- Clinical Study Site
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Kampung Baharu Nilai, Malaysia
- Clinical Study Site
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Kuala Lumpur, Malaysia
- Clinical Study Site #1
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Kuala Lumpur, Malaysia
- Clinical Study Site #2
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Kuching, Malaysia
- Clinical Study Site
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Pulau Pinang, Malaysia
- Clinical Study Site
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Tanjong Bungah, Malaysia
- Clinical Study Site
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Coahuila, Mexico
- Clinical Study Site
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Cuautitlán, Mexico
- Clinical Study Site
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Jalisco, Mexico
- Clinical Study Site
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León, Mexico
- Clinical Study Site
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Monterrey, Mexico
- Clinical Study Site 1
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Monterrey, Mexico
- Clinical Study Site 2
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Monterrey, Mexico
- Clinical Study Site 3
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Oaxaca City, Mexico
- Clinical Study Site
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San Luis Potosí City, Mexico
- Clinical Study Site
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Bacolod City, Philippines
- Clinical Study Site
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Batangas, Philippines
- Clinical Study Site
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Cebu, Philippines
- Clinical Study Site
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City of Taguig, Philippines
- Clinical Study Site
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Davao City, Philippines
- Clinical Study Site
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Manila, Philippines
- Clinical Study Site 1
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Manila, Philippines
- Clinical Study Site 2
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Quezon City, Philippines
- Clinical Study Site #1
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Quezon City, Philippines
- Clinical Study Site #2
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Dąbrowa Górnicza, Poland
- Clinical Study Site
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Gdynia, Poland
- Clinical Study Site
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Krakow, Poland
- Clinical Study Site
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Lodz, Poland
- Clinical Study Site
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Olsztyn, Poland
- Clinical Study Site
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Poznan, Poland
- Clinical Study Site
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Prabuty, Poland
- Clinical Study Site
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Radom, Poland
- Clinical Study Site
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Rzeszów, Poland
- Clinical Study Site
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Torun, Poland
- Clinical Study Site
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Warsaw, Poland
- Clinical Study Site
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Wodzisław Śląski, Poland
- Clinical Study Site
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Craiova, Romania
- Clinical Study Site 1
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Craiova, Romania
- Clinical Study Site 2
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Floreşti, Romania
- Clinical Study Site
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Ploieşti, Romania
- Clinical Study Site
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Timișoara, Romania
- Clinical Study Site
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Arkhangelsk, Russia
- Clinical Study Site
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Belgorod, Russia
- Clinical Study Site
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Chelyabinsk, Russia
- Clinical Study Site
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Kaluga, Russia
- Clinical Study Site
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Kazan', Russia
- Clinical Study Site
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Kemerovo, Russia
- Clinical Study Site
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Kislino, Russia
- Clinical Study Site
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Kursk, Russia
- Clinical Study Site
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Moscow, Russia
- Clinical Study Site 1
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Moscow, Russia
- Clinical Study Site 2
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Moscow, Russia
- Clinical Study Site 3
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Omsk, Russia
- Clinical Study Site
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Pyatigorsk, Russia
- Clinical Study Site
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Saint Petersburg, Russia
- Clinical Study Site 1
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Saint Petersburg, Russia
- Clinical Study Site 2
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Saint Petersburg, Russia
- Clinical Study Site 3
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Saint Petersburg, Russia
- Clinical Study Site 4
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Samara, Russia
- Clinical Study Site
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Saransk, Russia
- Clinical Study Site
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Sochi, Russia
- Clinical Study Site
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Tomsk, Russia
- Clinical Study Site 1
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Tomsk, Russia
- Clinical Study Site 2
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Yekaterinburg, Russia
- Clinical Study Site
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Republic Bashkortost
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Ufa, Republic Bashkortost, Russia
- Clinical Study Site
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Sankt-Peterburg
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Pushkin, Sankt-Peterburg, Russia
- Clinical Study Site
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Barcelona, Spain
- Clinical Study Site
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Pamplona, Spain
- Clinical Study Site
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Barcelona
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Manresa, Barcelona, Spain
- Clinical Study Site
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Chang-hua, Taiwan
- Clinical Study Site
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Hualien City, Taiwan
- Clinical Study Site
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Kaohsiung City, Taiwan
- Clinical Study Site 1
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Kaohsiung City, Taiwan
- Clinical Study Site 2
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New Taipei City, Taiwan
- Clinical Study Site 1
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New Taipei City, Taiwan
- Clinical Study Site 2
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Taichung, Taiwan
- Clinical Study Site 1
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Taichung, Taiwan
- Clinical Study Site 2
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Taipei, Taiwan
- Clinical Study Site 1
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Taipei, Taiwan
- Clinical Study Site 2
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Taipei, Taiwan
- Clinical Study Site 3
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Bangkok, Thailand
- Clinical Study Site #1
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Bangkok, Thailand
- Clinical Study Site #2
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Chiang Rai, Thailand
- Clinical Study Site
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Khon Kaen, Thailand
- Clinical Study Site
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Lampang, Thailand
- Clinical Study Site
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Phitsanulok, Thailand
- Clinical Study Site
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Ratchathewi, Thailand
- Clinical Study Site
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Udon Thani, Thailand
- Clinical Study Site
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Thailand
- Clinical Study Site
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Muang
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Lopburi, Muang, Thailand
- Clinical Study Site
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Adana, Turkey (Türkiye)
- Clinical Study Site 1
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Adana, Turkey (Türkiye)
- Clinical Study Site 2
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Ankara, Turkey (Türkiye)
- Clinical Study Site 1
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Ankara, Turkey (Türkiye)
- Clinical Study Site 2
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Ankara, Turkey (Türkiye)
- Clinical Study Site 3
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Ankara, Turkey (Türkiye)
- Clinical Study Site 4
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Ankara, Turkey (Türkiye)
- Clinical Study Site 5
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Edirne, Turkey (Türkiye)
- Clinical Study Site
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Istanbul, Turkey (Türkiye)
- Clinical Study Site 1
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Istanbul, Turkey (Türkiye)
- Clinical Study Site 2
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Istanbul, Turkey (Türkiye)
- Clinical Study Site 3
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Istanbul, Turkey (Türkiye)
- Clinical Study Site 4
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Izmir, Turkey (Türkiye)
- Clinical Study Site 1
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Izmir, Turkey (Türkiye)
- Clinical Study Site 2
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Izmir, Turkey (Türkiye)
- Clinical Study Site 3
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Samsun, Turkey (Türkiye)
- Clinical Study Site
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Dnipro, Ukraine
- Clinical Study Site
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Ivano-Frankivsk, Ukraine
- Clinical Study Site
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Kharkiv, Ukraine
- Clinical Study Site
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Kherson, Ukraine
- Clinical Study Site
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Kiev, Ukraine
- Clinical Study Site 1
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Kiev, Ukraine
- Clinical Study Site 2
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Kirovohrad, Ukraine
- Clinical Study Site
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Kyiv, Ukraine
- Clinical Study Site 1
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Kyiv, Ukraine
- Clinical Study Site 2
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Uzhhorod, Ukraine
- Clinical Study Site
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Vinnytsia, Ukraine
- Clinical Study Site
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Zaporizhzhya, Ukraine
- Clinical Study Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
A patient must meet the following criteria to be eligible for inclusion in the study:
- 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
- Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
- Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
- At least 1 radiographically measureable lesion per RECIST 1.1
- ECOG performance status of ≤1
- Anticipated life expectancy of at least 3 months
- Adequate organ and bone marrow function
Key Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
- Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
- Active or untreated brain metastases or spinal cord compression
- Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
- 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
- Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
- Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
- Another malignancy that is progressing or requires treatment
- Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
- Active infection requiring systemic therapy within 14 days prior to randomization
- Prior therapy with anti-PD 1 or anti-PD L1
- Treatment-related immune-mediated AEs from immune-modulatory agents
- Receipt of an investigational drug or device within 30 days
- Receipt of a live vaccine within 30 days of planned start of study medication
- Major surgery or significant traumatic injury within 4 weeks prior to first dose
- Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
- Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
- Pregnant or breastfeeding women
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 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 |
Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
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Experimental: cemiplimab
cemiplimab regimen as monotherapy as per study protocol
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Patients will be administered cemiplimab as per protocol.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Survival (OS)
Time Frame: Up to 94 months
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OS was defined as the time from randomization to the date of death due to any cause.
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Up to 94 months
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Progression-free Survival (PFS) Per Blinded IRC
Time Frame: Up to 94 months
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PFS as assessed by blinded IRC per RECIST 1.1 was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.
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Up to 94 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Objective Response Rate (ORR) Per IRC
Time Frame: Up to 73.5 months
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ORR was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by IRC per RECIST 1.1.
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Up to 73.5 months
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Best Overall Response (BOR) Per IRC
Time Frame: Up to 73.5 months
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BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.
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Up to 73.5 months
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Duration of Response (DoR) Per IRC
Time Frame: Up to 73.5 months
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DoR was defined as the time from date of first documented response of CR or PR to the date of first documented PD (per RECIST 1.1) or death due to any cause, whichever occurred earlier.
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Up to 73.5 months
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Change From Baseline in Global Health Status/Quality of Life (QoL) Scores as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39
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The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants.
It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (physical, role, cognitive, emotional, social), 9 symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact).
Reported here are the EORTC QLQ-C30 GHS/QoL scores only.
GHS/QoL is derived from two items: "How would you rate your overall health during the past week?"
and "How would you rate your overall quality of life during the past week?"
Each scored from 1 (very poor) to 7 (excellent).
The average of these two items is linearly transformed to a score ranging from 0 to 100; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.
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Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39
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Change From Baseline in Coughing Scores as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)
Time Frame: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39
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EORTC QLQ-LC13 is a 13-item questionnaire used in clinical research to assess health-related quality of life in lung cancer patients.
The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia).
Reported here are the EORTC lung cancer coughing scores only.
Scores were calculated and transformed to a range from 0 to 100, with a higher score representing a higher level of symptoms/problems and a negative change from baseline value indicating reduction (i.e.
improvement) in symptoms.
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Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 94 months
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TEAEs were AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.
A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
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Up to 94 months
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Number of Participants With Serious TEAEs
Time Frame: Up to 94 months
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Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.
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Up to 94 months
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Number of Deaths During the On-Treatment Period
Time Frame: Up to approximately 28 months
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The on-treatment period was defined as the day from the first dose of study drug to the day of the last dose of study drug plus 90 days or 1 day before participants receive their first dose of new anti-cancer systemic therapy, whichever is earlier.
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Up to approximately 28 months
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Number of Participants With Laboratory Abnormalities
Time Frame: Up to approximately 28 months
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Reported here is the number of participants with at least one laboratory abnormality of any grade in measurements for hematology, electrolytes, liver function, chemistry, and coagulation.
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Up to approximately 28 months
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Trough Concentration (Ctrough) of Cemiplimab in Serum
Time Frame: Up to 73.5 months
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Up to 73.5 months
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Maximum Plasma Concentration (Cmax) of Cemiplimab in Serum
Time Frame: Up to 73.5 months
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Up to 73.5 months
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Number of Participants With Anti-Cemiplimab Antibodies (ADA)
Time Frame: Up to 73.5 months
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The ADA status of each participant was classified as one of the following:
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Up to 73.5 months
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Number of Participants With Neutralizing Antibodies (NAb)
Time Frame: Up to 73.5 months
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The NAb status of each participant was categorized as follows:
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Up to 73.5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Gandara DR, Gumus M, Kilickap S, Sezer A, Bondarenko I, Ozguroglu M, Gogishvili M, Yan E, Jia X, Kim E, Seebach F, Quek RGW. Review of patient-reported outcomes in EMPOWER-Lung 1 in patients with advanced non-small cell lung cancer treated with cemiplimab versus chemotherapy. Cancer. 2026 Mar 15;132(6):e70339. doi: 10.1002/cncr.70339.
- Kilickap S, Baramidze A, Sezer A, Ozguroglu M, Gumus M, Bondarenko I, Gogishvili M, Nechaeva M, Schenker M, Cicin I, Fuang HG, Kulyaba Y, Zyuhal K, Scheusan RI, Garassino MC, Li Y, Zhu C, Kaul M, Perez J, Seebach F, Lowy I, Pouliot JF, Kim E, Magnan H. Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC With PD-L1 Expression of 50% or Higher: Five-Year Outcomes of EMPOWER-Lung 1. J Thorac Oncol. 2025 Jul;20(7):941-954. doi: 10.1016/j.jtho.2025.03.033. Epub 2025 Mar 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2017
Primary Completion (Actual)
April 18, 2025
Study Completion (Actual)
April 18, 2025
Study Registration Dates
First Submitted
March 3, 2017
First Submitted That Met QC Criteria
March 16, 2017
First Posted (Actual)
March 23, 2017
Study Record Updates
Last Update Posted (Actual)
June 25, 2026
Last Update Submitted That Met QC Criteria
May 29, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Amino Acids, Peptides, and Proteins
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Hydrocarbons
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Terpenes
- Inorganic Chemicals
- Chlorine Compounds
- Nitrogen Compounds
- Coordination Complexes
- Guanine
- Hypoxanthines
- Purinones
- Purines
- Glutamates
- Amino Acids, Acidic
- Amino Acids
- Amino Acids, Dicarboxylic
- Taxoids
- Cyclodecanes
- Diterpenes
- Deoxycytidine
- Cytidine
- Pyrimidine Nucleosides
- Pyrimidines
- Platinum Compounds
- Pemetrexed
- Gemcitabine
- Carboplatin
- Paclitaxel
- Cisplatin
- cemiplimab
Other Study ID Numbers
- R2810-ONC-1624
- 2016-004407-31 (EudraCT Number)
- 2024-515052-20-00 (Registry Identifier: EUCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD Sharing Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli.
Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.