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

Last updated: April 23, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Cisplatin

Placebo

Paclitaxel

Clinical Study ID

NCT04205812
INCMGA 0012-304
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous)that is Stage IV (AJCC v8).

  • No prior systemic treatment for the advanced/metastatic NSCLC

  • Able to provide a formalin-fixed archival tumor tissue sample during screening, or afresh tumor biopsy

  • Measurable disease per RECIST v1.1.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Life expectancy of at least 3 months.

  • Willingness to avoid pregnancy or fathering children.

  • Adequate organ function as indicated by protocol-specified laboratory values. - Hasbeen fully vaccinated against SARS-CoV-2 or is willing and able to be fullyvaccinated against SARS-CoV-2 during the study by starting the vaccination processduring screening.

Exclusion

Exclusion Criteria:

  • Clinically significant cardiac disease within 6 months of start of study treatment.

  • Any major surgery within 3 weeks of the first dose of study treatment.

  • Thoracic radiation therapy of > 30 Gy within 6 months of the first dose of studytreatment.

  • History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receivecisplatin, paclitaxel, or nab-paclitaxel.

  • Untreated central nervous system metastases and/or carcinomatous meningitis.

  • Evidence or history of interstitial lung disease or noninfectious pneumonitis thatrequired systemic steroids.

  • Active infection requiring systemic therapy or active tuberculosis. Note: Ifrequired by country or local regulations to be tested for COVID-19 during screening,a participant should be excluded if they have a positive test result for SARS CoV-2infection until both the retesting result is negative and clinical recovery isobtained.

  • Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervicalcancer, or other in situ cancers.

  • Has contraindications to chemotherapy agents used in the study.

  • Has an active autoimmune disease that has required systemic treatment in past 2years.

  • Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the firstdose of study treatment.

  • Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug).

Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained.

• Has known active HBV or HCV (testing must be performed to determine eligibility)

Study Design

Total Participants: 583
Treatment Group(s): 7
Primary Treatment: Cisplatin
Phase: 3
Study Start date:
September 11, 2020
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Instituto de Investigaciones Metabolicas (Idim)

    Ciudad Autonoma Buenos Aires, C1012AAR
    Argentina

    Site Not Available

  • Hospital Privado Centro Medico de Cordoba S.A

    Cordoba, 05016
    Argentina

    Site Not Available

  • Sanatorio Parque S.A.

    Rosario, S2000DSV
    Argentina

    Site Not Available

  • Cer San Juan Centro Polivalente de Asistencia E Inv. Clinica

    San Juan, 05400
    Argentina

    Site Not Available

  • Centro Medico San Roque S.R.L.

    San Miguel de Tucuman, 04000
    Argentina

    Site Not Available

  • Clinicas Viedma S.A.

    Viedma, R8500ACE
    Argentina

    Site Not Available

  • Fundacao Pio Xii Hospital de Cancer de Barretos

    Barretos, 14784-400
    Brazil

    Site Not Available

  • Incan - Instituto Do Cancer - Hospital Pompeia

    Caxias Do Sul, 95010-005
    Brazil

    Site Not Available

  • Centro Regional Integrado de Oncologia

    Fortaleza, 60336-045
    Brazil

    Site Not Available

  • Oncosite - Centro de Pesquisa Clinica E Oncologia

    IJU, 98700-000
    Brazil

    Site Not Available

  • Oncosite - Centro de Pesquisa Clinica E Oncologia

    Ijua, 98700-000
    Brazil

    Site Not Available

  • Oncosite - Centro de Pesquisa Clinica E Oncologia

    Ijui, 98700-000
    Brazil

    Site Not Available

  • Clinica de Neoplasias Litoral Ltda

    Itaja, 88301-220
    Brazil

    Site Not Available

  • Clinica de Neoplasias Litoral Ltda

    Itajai, 88301-220
    Brazil

    Site Not Available

  • Clinica de Neoplasias Litoral Ltda

    Itajaí, 88301-220
    Brazil

    Site Not Available

  • Hospital Do Cancer de Londrina

    Londrina, 86015-520
    Brazil

    Site Not Available

  • Instituto Mederi de Pesquisa E Saude

    Passo Fundo, 99010-120
    Brazil

    Site Not Available

  • Hgb - Hospital Giovanni Battista - Mae de Deus Center

    Porto Alegre, 90470-340
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    Rio Preto, 5524
    Brazil

    Site Not Available

  • Inca - Instituto Nacional de Cancer

    Rio de Janeiro, 20230-130
    Brazil

    Site Not Available

  • Sao Camilo Oncologia

    S?O Paulo, 03102-002
    Brazil

    Site Not Available

  • Ibcc - Instituto Brasileiro de Controle Do Cancer

    San Paulo, 03102-002
    Brazil

    Site Not Available

  • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo ANDR, 09060-870
    Brazil

    Site Not Available

  • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo Andra, 09060-870
    Brazil

    Site Not Available

  • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo Andre, 09060-870
    Brazil

    Site Not Available

  • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo André, 09060-870
    Brazil

    Site Not Available

  • A. C. Camargo Cancer Center

    Santo Paulo, 01509-900
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    Sao Jose, 15090-000
    Brazil

    Site Not Available

  • Sao Camilo Oncologia

    Sao Paulo, 03102-002
    Brazil

    Site Not Available

  • Sao Camilo Oncologia

    São Paulo, 03102-002
    Brazil

    Site Not Available

  • Sao Camilo Oncologia

    S�O Paulo, 03102-002
    Brazil

    Site Not Available

  • Acibadem Cityclinica Mhat Tokuda

    Sofia, 01407
    Bulgaria

    Site Not Available

  • Mc Women'S Health-Nadezhda Eood

    Sofia, 01330
    Bulgaria

    Site Not Available

  • Mhat Serdika Eood

    Sofia, 01632
    Bulgaria

    Site Not Available

  • Multiprofile Hospital For Active Treatment Central Onco Hospital Ood

    Sofia, 01797
    Bulgaria

    Site Not Available

  • Umhat Sv. Ivan Rilski Ead

    Sofia, 01431
    Bulgaria

    Site Not Available

  • Shatod Dr Marko Marko - Varna Ltd

    Varna, 09002
    Bulgaria

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, 410013
    China

    Site Not Available

  • The First Affiliated Hospital Sun Yat-Sen University

    Guangzhou, 510080
    China

    Site Not Available

  • Hangzhou Cancer Hospital

    Hangzhou, 310002
    China

    Site Not Available

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310001
    China

    Site Not Available

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, 310003
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, 310022
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, 150081
    China

    Site Not Available

  • The Second Hospital of Anhui Medical University

    Hefei, 230601
    China

    Site Not Available

  • University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)

    Hefei, 230001
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, 250013
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi, 276001
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, 200030
    China

    Site Not Available

  • General Hospital of Tianjin

    Tianjing, 300052
    China

    Site Not Available

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Urumqi, 830000
    China

    Site Not Available

  • Henan Cancer Hostipal

    Zhengzhou, 450003
    China

    Site Not Available

  • Henan Provincial Peoples Hospital

    Zhengzhou, 450003
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052
    China

    Site Not Available

  • University Hospital Hradec Kralove

    Hradec Kralove, 50333
    Czechia

    Site Not Available

  • Fakultni Nemocnice Olomouc

    Olomouc, 775 20
    Czechia

    Site Not Available

  • Nemocnice Agel Ostrava - Vitkovice A.S

    Ostrava - Vitkovice, 703 84
    Czechia

    Site Not Available

  • Fakultni Nemocnice V Motole

    Praha 5, 150 06
    Czechia

    Site Not Available

  • High Technology Hospital Medcenter

    Batumi, 06000
    Georgia

    Site Not Available

  • Jsc Evex Hospitals

    Kutaisi, 04600
    Georgia

    Site Not Available

  • Archangel St. Michael Multi Profile Clinical Hospital

    Tbilisi, 00102
    Georgia

    Site Not Available

  • Cancer Research Center Ltd

    Tbilisi, 00177
    Georgia

    Site Not Available

  • HIGH TECHNOLOGY MEDICAL�CENTER, UNIVERSITY CLINIC

    Tbilisi, 00144
    Georgia

    Active - Recruiting

  • High Technology Medical Center, University Clinic

    Tbilisi, 00144
    Georgia

    Site Not Available

  • Institute of Clinical Oncology Ltd

    Tbilisi, 00159
    Georgia

    Site Not Available

  • Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi, 00112
    Georgia

    Site Not Available

  • Medulla Chemotherapy and Immunotherapy Clinic

    Tbilisi, 00141
    Georgia

    Site Not Available

  • New Hospitals

    Tbilisi, 00114
    Georgia

    Site Not Available

  • Tbilisi State Medical University First University Clinic

    Tbilisi, 00141
    Georgia

    Site Not Available

  • Orszagos Koranyi Tbc Es Pulmonological Intezet

    Budapest, 01121
    Hungary

    Site Not Available

  • Bacs Kiskun Megyei Oktatokorhaz

    Kecskemet, 06000
    Hungary

    Site Not Available

  • Advanced Medical and Dental Institute Husm

    Kepala Batas, 13200
    Malaysia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching, 93586
    Malaysia

    Site Not Available

  • Beacon Hospital Sdn Bhd

    Petaling Jaya, 46050
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang

    Pulau Pinang, 10990
    Malaysia

    Site Not Available

  • Institut Kanser Negara - National Cancer Institute

    Putrajaya, 62250
    Malaysia

    Site Not Available

  • Centro Oncologico de Chihuahua (Coc)

    Chihuahua, 31217
    Mexico

    Site Not Available

  • Investigacion Onco Farmaceutica S. de R.L. de C.V. (Oncotech)

    La Paz, 23040
    Mexico

    Site Not Available

  • Coi Centro Oncologico Internacional S.A.P.I. de C.V.

    Mexico, 04700
    Mexico

    Site Not Available

  • Health Pharma Professional Research S.A. de C.V.

    Mexico City, 03810
    Mexico

    Site Not Available

  • Axis Heilsa S. de R.L. de C.V.

    Monterrey, 64060
    Mexico

    Site Not Available

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, 64460
    Mexico

    Site Not Available

  • Clinical Medical Research S.C.

    Orizaba, 94300
    Mexico

    Site Not Available

  • Oncologico Potosino

    SAN LUIS Potos, 78250
    Mexico

    Site Not Available

  • Oncologico Potosino

    San Luis, 78250
    Mexico

    Site Not Available

  • Oncologico Potosino

    San Luis Potosi, 78250
    Mexico

    Site Not Available

  • Oncologico Potosino

    San Luis Potosí, 78250
    Mexico

    Site Not Available

  • Cebu Doctors University Hospital

    Cebu City, 06000
    Philippines

    Site Not Available

  • Davao Doctors Hospital

    Davao City, 08000
    Philippines

    Site Not Available

  • West Visayas State University Medical Center

    Iloilo City, 05000
    Philippines

    Site Not Available

  • Makati Medical Center

    Makati, 01229
    Philippines

    Site Not Available

  • Makati Medical Center

    Makati City, 01229
    Philippines

    Site Not Available

  • Philippine General Hospital

    Manila, 01000
    Philippines

    Site Not Available

  • Asian Hospital and Medical Center

    Muntinlupa, 01781
    Philippines

    Site Not Available

  • The Medical City

    Pasig City, 01605
    Philippines

    Site Not Available

  • St. Lukes Medical Center

    Quezon City, 01102
    Philippines

    Site Not Available

  • Ko-Med Centra Kliniczne Biala Podlaska

    Biala Podlaska, 21-500
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    KRAK�W, 30-363
    Poland

    Site Not Available

  • Przychodnia Lekarska Komed

    Konin, 62-500
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, 30-363
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna

    Lodz, 90-242
    Poland

    Site Not Available

  • Przychodnia Med-Polonia Sp. Z O.O.

    Poznan, 60-693
    Poland

    Site Not Available

  • S.C Oncopremium Team S.R.L

    Baia Mare, 430295
    Romania

    Site Not Available

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj Napoca, 400015
    Romania

    Site Not Available

  • Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca

    Cluj-napoca, 400132
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Constanta

    Constanta, 900591
    Romania

    Site Not Available

  • Oncomed Srl

    Timisoara, 300239
    Romania

    Site Not Available

  • S C Oncocenter Oncologie Medicala S R L

    Timisoara, 300166
    Romania

    Site Not Available

  • Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee

    Kursk, 305035
    Russian Federation

    Site Not Available

  • Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams

    Moscow, 121309
    Russian Federation

    Site Not Available

  • Llc Tonus

    Nizniy Novgorod, 603089
    Russian Federation

    Site Not Available

  • Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary

    Novosibirsk, 630108
    Russian Federation

    Site Not Available

  • Bhi of Omsk Region Clinical Oncology Dispensary

    Omsk, 644013
    Russian Federation

    Site Not Available

  • N.N. Petrov Research Institute of Oncology

    Pos.pesochnyi, 197758
    Russian Federation

    Site Not Available

  • N.N. Petrov Research Institute of Oncology

    Saint-petersburg, 197758
    Russian Federation

    Site Not Available

  • Pavlov First Saint Petersburg State Medical University

    Saint-petersburg, 197022
    Russian Federation

    Site Not Available

  • N.N. Petrov Research Institute of Oncology

    St Petersburg, 197758
    Russian Federation

    Site Not Available

  • Sbhi Volgograd Regional Onclogy Dispensary

    Volgograd, 400138
    Russian Federation

    Site Not Available

  • Oncomed-System

    Belgrad, 11000
    Serbia

    Site Not Available

  • Clinical Center Bezanijska Kosa

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center of Serbia

    Belgrade, 11 000
    Serbia

    Site Not Available

  • Oncomed-System

    Beograd, 11000
    Serbia

    Site Not Available

  • Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Institute For Pulmonary Diseases of Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Cancercare Rondebosch Oncology Centre

    Cape Town, 07700
    South Africa

    Site Not Available

  • Cape Town Oncology Trials (Pty) Ltd

    Cape Town, 07570
    South Africa

    Site Not Available

  • Sandton Oncology Centre

    Johannesburg, 02196
    South Africa

    Site Not Available

  • Wits Clinical Research

    Johannesburg, 02193
    South Africa

    Site Not Available

  • Mary Potter Oncology Centre

    Pretoria, 00181
    South Africa

    Site Not Available

  • University of Pretoria Oncology Department

    Pretoria, 00002
    South Africa

    Site Not Available

  • Acibadem Adana Hospital

    Adana, 01130
    Turkey

    Site Not Available

  • Adana Sehir Hastanesi

    Adana, 01230
    Turkey

    Site Not Available

  • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital

    Ankara, 06105
    Turkey

    Site Not Available

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100
    Turkey

    Site Not Available

  • Memorial Ankara Hospital

    Ankara, 06520
    Turkey

    Site Not Available

  • Yildirim Beyazit University Ankara Ataturk Training and Research Hospital

    Ankara, 06800
    Turkey

    Site Not Available

  • Memorial Antalya Hastanesi

    Antalya, 07020
    Turkey

    Site Not Available

  • Trakya Universitesi Tip Fakultesi

    Edirne, 22030
    Turkey

    Site Not Available

  • Gaziantep University Gaziantep Oncology Hospital

    Gaziantep, 27310
    Turkey

    Site Not Available

  • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital

    Istanbul, 34147
    Turkey

    Site Not Available

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098
    Turkey

    Site Not Available

  • Medipol University Medical Faculty

    Istanbul, 34214
    Turkey

    Site Not Available

  • Izmir Medicalpark Hospital

    Izmir, 35530
    Turkey

    Site Not Available

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi

    Konya, 42080
    Turkey

    Site Not Available

  • Inonu Universitesi Turgut Ozal Tip Merkezi

    Malatya, 44280
    Turkey

    Site Not Available

  • Multifield Clinical Hospital No 4

    Dnipro, 49102
    Ukraine

    Site Not Available

  • Ci Carpathian Clinical Oncological Center

    Ivano-frankivsk, 76018
    Ukraine

    Site Not Available

  • Communal Non-Profit Enterprise Regional Center of Oncology

    Kharkiv, 61070
    Ukraine

    Site Not Available

  • V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • Kherson Regional Oncologic Dispensary

    Kherson, 73000
    Ukraine

    Site Not Available

  • Pp Ppc Acinus Medical and Diagnostic Centre

    Kropyvnytskyi, 25006
    Ukraine

    Site Not Available

  • Mi Kryviy Rih Center of Dnipropetrovsk Regional Council

    Kryvyi Rih, 50048
    Ukraine

    Site Not Available

  • Ci of Krc Kyiv Regional Oncologic Dispensary

    Kyiv, 04107
    Ukraine

    Site Not Available

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115
    Ukraine

    Site Not Available

  • Medical Center Asklepion Llc

    Kyiv, 03126
    Ukraine

    Site Not Available

  • Volyn Regional Oncological Dispensary

    Lutsk, 43018
    Ukraine

    Site Not Available

  • Rmi Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022
    Ukraine

    Site Not Available

  • Cne Ccch of Uzh Cc Oncological Center

    Uzhgorod, 88000
    Ukraine

    Site Not Available

  • Medical Center Oncolife Llc

    Zaporizhzhia, 69059
    Ukraine

    Site Not Available

  • Pacific Cancer Medical Center

    Anaheim, California 92801
    United States

    Site Not Available

  • Innovative Clinical Research Institute

    Whittier, California 90603
    United States

    Site Not Available

  • Reading Hospital and Medical Center

    Reading, Pennsylvania 19612
    United States

    Site Not Available

  • Can Tho Oncology Hospital

    Can Tho, 00000
    Vietnam

    Site Not Available

  • 103 Military Hospital

    Hanoi, 00000
    Vietnam

    Site Not Available

  • Bach Mai Hospital

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Hanoi Oncology Hospital

    Hanoi, 100000
    Vietnam

    Site Not Available

  • National Cancer Hospital

    Hanoi, 100000
    Vietnam

    Site Not Available

  • National Lung Hospital

    Hanoi, 10000
    Vietnam

    Site Not Available

  • Hcmc Oncology Hospital

    Ho Chi Minh City, 722681
    Vietnam

    Site Not Available

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