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ACTIVE NOT RECRUITING
NCT04205812
PHASE3

Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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

Interventions

DRUG

Retifanlimab

INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

DRUG

Placebo

Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

DRUG

Pemetrexed

Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.

DRUG

Cisplatin

Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

DRUG

Carboplatin

Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

DRUG

Paclitaxel

Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

DRUG

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