Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
NCT ID: NCT04205812
Last Updated: 2025-09-25
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
583 participants
INTERVENTIONAL
2020-09-11
2026-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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INCMGA00012 + chemotherapy (nonsquamous NSCLC)
INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
Retifanlimab
INCMGA00012 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.
Placebo + chemotherapy (nonsquamous NSCLC)
Placebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.
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.
INCMGA00012 + chemotherapy (squamous NSCLC)
INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
Retifanlimab
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 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.
Placebo + chemotherapy (squamous NSCLC)
Placebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.
Placebo
Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior systemic treatment for the advanced/metastatic NSCLC
* Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh 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. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.
Exclusion Criteria
* 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 study treatment.
* History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.
* Untreated central nervous system metastases and/or carcinomatous meningitis.
* Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.
* Active infection requiring systemic therapy or active tuberculosis. Note: If required 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-2 infection until both the retesting result is negative and clinical recovery is obtained.
* Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, 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 2 years.
* Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose 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)
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Countries
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References
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Lu S, Vynnychenko O, Kulyaba Y, Kuchava V, Ibrahim A, Moiseenko F, Arslan C, Nguyen DT, Petrovic M, Cicin I, Bibichadze K, Cil T, Shi J, Olmez OF, Gogishvili M, Artac M, Nguyen HG, Cornfeld M, Tian C, Munteanu MC, Sette CVM, Bondarenko I; POD1UM-304 Study Team. Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study. Lancet Respir Med. 2025 Sep 19:S2213-2600(25)00209-7. doi: 10.1016/S2213-2600(25)00209-7. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-003372-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-501987-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCMGA 0012-304
Identifier Type: -
Identifier Source: org_study_id
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