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Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
Sponsor: Incyte Corporation
Summary
The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).
Official title: A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
583
Start Date
2020-09-11
Completion Date
2026-08-28
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Retifanlimab
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Placebo
Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Pemetrexed
Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.
Cisplatin
Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Carboplatin
Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Paclitaxel
Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
nab-Paclitaxel
nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.
Locations (140)
Pacific Cancer Medical Center
Anaheim, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos, Brazil
Incan - Instituto Do Cancer - Hospital Pompeia
Caxias do Sul, Brazil
Centro Regional Integrado de Oncologia
Fortaleza, Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijuí, Brazil
Clinica de Neoplasias Litoral Ltda
Itajaí, Brazil
Hospital Do Cancer de Londrina
Londrina, Brazil
Instituto Mederi de Pesquisa E Saude
Passo Fundo, Brazil
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre, Brazil
Inca - Instituto Nacional de Cancer
Rio de Janeiro, Brazil
Sao Camilo Oncologia
S?O Paulo, Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José, Brazil
Mc Women'S Health-Nadezhda Eood
Sofia, Bulgaria
Acibadem Cityclinica Mhat Tokuda
Sofia, Bulgaria
Umhat Sv. Ivan Rilski Ead
Sofia, Bulgaria
Mhat Serdika Eood
Sofia, Bulgaria
Multiprofile Hospital For Active Treatment Central Onco Hospital Ood
Sofia, Bulgaria
Shatod Dr Marko Marko - Varna Ltd
Varna, Bulgaria
Hunan Cancer Hospital
Changsha, China
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Hangzhou Cancer Hospital
Hangzhou, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei, China
The Second Hospital of Anhui Medical University
Hefei, China
Jinan Central Hospital
Jinan, China
Linyi Cancer Hospital
Linyi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Shanghai Chest Hospital
Shanghai, China
General Hospital of Tianjin
Tianjing, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China
Henan Cancer Hostipal
Zhengzhou, China
Henan Provincial Peoples Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
University Hospital Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Olomouc
Olomouc, Czechia
Nemocnice Agel Ostrava - Vitkovice A.S
Ostrava - Vitkovice, Czechia
Fakultni Nemocnice V Motole
Prague, Czechia
High Technology Hospital Medcenter
Batumi, Georgia
Jsc Evex Hospitals
Kutaisi, Georgia
Archangel St. Michael Multi Profile Clinical Hospital
Tbilisi, Georgia
Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
New Hospitals
Tbilisi, Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia
Tbilisi State Medical University First University Clinic
Tbilisi, Georgia
High Technology Medical Center, University Clinic
Tbilisi, Georgia
Institute of Clinical Oncology Ltd
Tbilisi, Georgia
Cancer Research Center Ltd
Tbilisi, Georgia
Orszagos Koranyi Tbc Es Pulmonological Intezet
Budapest, Hungary
Bacs Kiskun Megyei Oktatokorhaz
Kecskemét, Hungary
Advanced Medical and Dental Institute Husm
Kepala Batas, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya, Malaysia
Hospital Pulau Pinang
Pulau Pinang, Malaysia
Institut Kanser Negara - National Cancer Institute
Putrajaya, Malaysia
Cebu Doctors University Hospital
Cebu City, Philippines
Asian Hospital and Medical Center
City of Muntinlupa, Philippines
Davao Doctors Hospital
Davao City, Philippines
West Visayas State University Medical Center
Iloilo City, Philippines
Makati Medical Center
Makati, Philippines
Makati Medical Center
Makati City, Philippines
Philippine General Hospital
Manila, Philippines
The Medical City
Pasig, Philippines
St. Lukes Medical Center
Quezon City, Philippines
Ko-Med Centra Kliniczne Biala Podlaska
Biała Podlaska, Poland
Przychodnia Lekarska Komed
Konin, Poland
Centrum Medyczne Plejady
Krakow, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
Lodz, Poland
Przychodnia Med-Polonia Sp. Z O.O.
Poznan, Poland
S.C Oncopremium Team S.R.L
Baia Mare, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Romania
Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
Cluj-Napoca, Romania
Spitalul Clinic Judetean de Urgenta Constanta
Constanța, Romania
S C Oncocenter Oncologie Medicala S R L
Timișoara, Romania
Oncomed Srl
Timișoara, Romania
Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Russia
Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
Kursk, Russia
Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
Moscow, Russia
Llc Tonus
Nizniy Novgorod, Russia
Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
Novosibirsk, Russia
Bhi of Omsk Region Clinical Oncology Dispensary
Omsk, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russia
N.N. Petrov Research Institute of Oncology
Saint Petersburg, Russia
Sbhi Volgograd Regional Onclogy Dispensary
Volgograd, Russia
Clinical Center of Serbia
Belgrade, Serbia
Clinical Center Bezanijska Kosa
Belgrade, Serbia
Clinical Center of Serbia
Belgrade, Serbia
Oncomed-System
Belgrade, Serbia
Institute For Pulmonary Diseases of Vojvodina
Kamenitz, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Cape Town Oncology Trials (Pty) Ltd
Cape Town, South Africa
Cancercare Rondebosch Oncology Centre
Cape Town, South Africa
Wits Clinical Research
Johannesburg, South Africa
Sandton Oncology Centre
Johannesburg, South Africa
University of Pretoria Oncology Department
Pretoria, South Africa
Mary Potter Oncology Centre
Pretoria, South Africa
Acibadem Adana Hospital
Adana, Turkey (Türkiye)
Adana Sehir Hastanesi
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
Ankara, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, Turkey (Türkiye)
Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
Ankara, Turkey (Türkiye)
Memorial Antalya Hastanesi
Antalya, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi
Edirne, Turkey (Türkiye)
Gaziantep University Gaziantep Oncology Hospital
Gaziantep, Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
Istanbul, Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, Turkey (Türkiye)
Izmir Medicalpark Hospital
Izmir, Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
Konya, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya, Turkey (Türkiye)
Multifield Clinical Hospital No 4
Dnipro, Ukraine
Ci Carpathian Clinical Oncological Center
Ivano-Frankivsk, Ukraine
Communal Non-Profit Enterprise Regional Center of Oncology
Kharkiv, Ukraine
V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine
Kharkiv, Ukraine
Kherson Regional Oncologic Dispensary
Kherson, Ukraine
Pp Ppc Acinus Medical and Diagnostic Centre
Kropyvnytskyi, Ukraine
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih, Ukraine
Kyiv City Clinical Oncological Center
Kyiv, Ukraine
Medical Center Asklepion Llc
Kyiv, Ukraine
Ci of Krc Kyiv Regional Oncologic Dispensary
Kyiv, Ukraine
Volyn Regional Oncological Dispensary
Lutsk, Ukraine
Rmi Sumy Regional Clinical Oncology Dispensary
Sumy, Ukraine
Cne Ccch of Uzh Cc Oncological Center
Uzhhorod, Ukraine
Medical Center Oncolife Llc
Zaporizhzhia, Ukraine
Can Tho Oncology Hospital
Can Tho, Vietnam
103 Military Hospital
Hanoi, Vietnam
Bach Mai Hospital
Hanoi, Vietnam
Hanoi Oncology Hospital
Hanoi, Vietnam
National Cancer Hospital
Hanoi, Vietnam
National Lung Hospital
Hanoi, Vietnam
Hcmc Oncology Hospital
Ho Chi Minh City, Vietnam