Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer (POD1UM-304)

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Squamous Non-Small Cell Lung Cancer; Metastatic Nonsquamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Retifanlimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Placebo; Drug: Paclitaxel; Drug: nab-Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 583
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII Hospital de Câncer de Barretos
  • Caxias do Sul, Brazil, 95010-005
    • Incan - Instituto Do Cancer - Hospital Pompeia
  • Fortaleza, Brazil, 60336-045
    • Centro Regional Integrado de Oncologia
  • Ijuí, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clinica e Oncologia
  • Itajaí, Brazil, 88301-220
    • Clinica de Neoplasias Litoral Ltda
  • Londrina, Brazil, 86015-520
    • Hospital do Cancer de Londrina
  • Passo Fundo, Brazil, 99010-120
    • Instituto Mederi de Pesquisa e Saude
  • Porto Alegre, Brazil, 90470-340
    • Hgb - Hospital Giovanni Battista - Mae de Deus Center
  • Rio de Janeiro, Brazil, 20230-130
    • INCA - Instituto Nacional de Cancer
  • S?O Paulo, Brazil, 03102-002
    • Sao Camilo Oncologia
  • Santo André, Brazil, 09060-870
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • São José, Brazil, 15090-000
    • Fundação Faculdade Regional de Medicina de São José do Rio Preto
• Bulgaria
  • Sofia, Bulgaria, 01330
    • Mc Women'S Health-Nadezhda Eood
  • Sofia, Bulgaria, 01407
    • Acibadem Cityclinica Mhat Tokuda
  • Sofia, Bulgaria, 01431
    • Umhat Sv. Ivan Rilski Ead
  • Sofia, Bulgaria, 01632
    • MHAT Serdika EOOD
  • Sofia, Bulgaria, 01797
    • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
  • Varna, Bulgaria, 09002
    • Shatod Dr Marko Marko - Varna Ltd
• China
  • Changsha, China, 410013
    • Hunan Cancer Hospital
  • Guangzhou, China, 510080
    • The First Affiliated Hospital Sun Yat-Sen University
  • Hangzhou, China, 310003
    • The First Affiliated Hospital of Zhejiang University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310001
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Hangzhou, China, 310002
    • Hangzhou Cancer Hospital
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Hefei, China, 230601
    • The Second Hospital of Anhui Medical University
  • Hefei, China, 230001
    • University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
  • Jinan, China, 250013
    • Jinan Central Hospital
  • Linyi, China, 276001
    • Linyi Cancer Hospital
  • Nanchang, China, 330006
    • The Second Affiliated Hospital of Nanchang University
  • Nanning, China, 530021
    • The First Affiliated Hospital of Guangxi Medical University
  • Shanghai, China, 200030
    • Shanghai Chest Hospital
  • Tianjing, China, 300052
    • General Hospital of Tianjin
  • Zhengzhou, China, 450052
    • The First Affiliated Hospital of Zhengzhou University
  • Zhengzhou, China, 450003
    • Henan Cancer Hostipal
  • Zhengzhou, China, 450003
    • Henan Provincial Peoples Hospital
  • Ürümqi, China, 830000
    • The Affiliated Cancer Hospital of Xinjiang Medical University
• Czechia
  • Hradec Králové, Czechia, 50333
    • University Hospital Hradec Kralove
  • Olomouc, Czechia, 775 20
    • Fakultni nemocnice Olomouc
  • Ostrava - Vitkovice, Czechia, 703 84
    • Nemocnice Agel Ostrava - Vitkovice A.S
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
• Georgia
  • Batumi, Georgia, 06000
    • High Technology Hospital Medcenter
  • Kutaisi, Georgia, 04600
    • Jsc Evex Hospitals
  • Tbilisi, Georgia, 00102
    • Archangel St. Michael Multi Profile Clinical Hospital
  • Tbilisi, Georgia, 00112
    • Israel-Georgian Medical Research Clinic Helsicore
  • Tbilisi, Georgia, 00114
    • New Hospitals
  • Tbilisi, Georgia, 00141
    • Medulla Chemotherapy and Immunotherapy Clinic
  • Tbilisi, Georgia, 00141
    • Tbilisi State Medical University First University Clinic
  • Tbilisi, Georgia, 00144
    • High Technology Medical Center, University Clinic
  • Tbilisi, Georgia, 00159
    • Institute of Clinical Oncology LTD
  • Tbilisi, Georgia, 00177
    • Cancer Research Center Ltd
• Hungary
  • Budapest, Hungary, 01121
    • Orszagos Koranyi Tbc Es Pulmonological Intezet
  • Kecskemét, Hungary, 06000
    • Bacs Kiskun Megyei Oktatokorhaz
• Malaysia
  • Kepala Batas, Malaysia, 13200
    • Advanced Medical and Dental Institute Husm
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuantan, Malaysia, 25100
    • Hospital Tengku Ampuan Afzan
  • Kuching, Malaysia, 93586
    • Sarawak General Hospital
  • Petaling Jaya, Malaysia, 46050
    • Beacon Hospital Sdn Bhd
  • Pulau Pinang, Malaysia, 10990
    • Hospital Pulau Pinang
  • Putrajaya, Malaysia, 62250
    • Institut Kanser Negara - National Cancer Institute
• Philippines
  • Cebu City, Philippines, 06000
    • Cebu Doctors University Hospital
  • City of Muntinlupa, Philippines, 01781
    • Asian Hospital and Medical Center
  • Davao City, Philippines, 08000
    • Davao Doctors Hospital
  • Iloilo City, Philippines, 05000
    • West Visayas State University Medical Center
  • Makati, Philippines, 01229
    • Makati Medical Center
  • Makati City, Philippines, 01229
    • Makati Medical Center
  • Manila, Philippines, 01000
    • Philippine General Hospital
  • Pasig, Philippines, 01605
    • The Medical City
  • Quezon City, Philippines, 01102
    • St. Lukes Medical Center
• Poland
  • Biała Podlaska, Poland, 21-500
    • Ko-Med Centra Kliniczne Biala Podlaska
  • Konin, Poland, 62-500
    • Przychodnia Lekarska KOMED
  • Krakow, Poland, 30-363
    • Centrum Medyczne Plejady
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
  • Poznan, Poland, 60-693
    • Przychodnia Med-Polonia Sp. z o.o.
• Romania
  • Baia Mare, Romania, 430295
    • S.C Oncopremium Team S.R.L
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
  • Cluj-Napoca, Romania, 400132
    • Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
  • Constanța, Romania, 900591
    • Spitalul Clinic Judetean de Urgenta Constanta
  • Timișoara, Romania, 300239
    • Oncomed SRL
  • Timișoara, Romania, 300166
    • S C Oncocenter Oncologie Medicala S R L
• Russia
  • Arkhangelsk, Russia, 163045
    • Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
  • Kursk, Russia, 305035
    • Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
  • Moscow, Russia, 121309
    • Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
  • Nizniy Novgorod, Russia, 603089
    • LLC Tonus
  • Novosibirsk, Russia, 630108
    • Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
  • Omsk, Russia, 644013
    • BHI of Omsk region Clinical Oncology Dispensary
  • Saint Petersburg, Russia, 197758
    • N.N. Petrov Research Institute Of Oncology
  • Saint Petersburg, Russia, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Volgograd, Russia, 400138
    • Sbhi Volgograd Regional Onclogy Dispensary
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11 000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center Bezanijska kosa
  • Belgrade, Serbia, 11000
    • Oncomed-System
  • Kamenitz, Serbia, 21204
    • Institute for Pulmonary Diseases of Vojvodina
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
• South Africa
  • Cape Town, South Africa, 07570
    • Cape Town Oncology Trials (Pty) Ltd
  • Cape Town, South Africa, 07700
    • Cancercare Rondebosch Oncology Centre
  • Johannesburg, South Africa, 02193
    • Wits Clinical Research
  • Johannesburg, South Africa, 02196
    • Sandton Oncology Centre
  • Pretoria, South Africa, 00002
    • University of Pretoria Oncology Department
  • Pretoria, South Africa, 00181
    • Mary Potter Oncology Centre
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01130
    • Acibadem Adana Hospital
  • Adana, Turkey (Türkiye), 01230
    • Adana Şehir Hastanesi
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hospital
  • Ankara, Turkey (Türkiye), 06105
    • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
  • Antalya, Turkey (Türkiye), 07020
    • Memorial Antalya Hastanesi
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Universitesi Tip Fakultesi
  • Gaziantep, Turkey (Türkiye), 27310
    • Gaziantep University Gaziantep Oncology Hospital
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34147
    • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
  • Izmir, Turkey (Türkiye), 35530
    • Izmir Medicalpark Hospital
  • Konya, Turkey (Türkiye), 42080
    • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
  • Malatya, Turkey (Türkiye), 44280
    • Inonu Universitesi Turgut Ozal Tip Merkezi
• Ukraine
  • Dnipro, Ukraine, 49102
    • Multifield Clinical Hospital No 4
  • Ivano-Frankivsk, Ukraine, 76018
    • Ci Carpathian Clinical Oncological Center
  • Kharkiv, Ukraine, 61070
    • Communal Non-Profit Enterprise Regional Center of Oncology
  • Kharkiv, Ukraine, 61103
    • V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine
  • Kherson, Ukraine, 73000
    • Kherson Regional Oncologic Dispensary
  • Kropyvnytskyi, Ukraine, 25006
    • Pp Ppc Acinus Medical and Diagnostic Centre
  • Kryvyi Rih, Ukraine, 50048
    • MI Kryviy Rih Center of Dnipropetrovsk Regional Council
  • Kyiv, Ukraine, 03115
    • Kyiv City Clinical Oncological Center
  • Kyiv, Ukraine, 03126
    • Medical Center Asklepion Llc
  • Kyiv, Ukraine, 04107
    • Ci of Krc Kyiv Regional Oncologic Dispensary
  • Lutsk, Ukraine, 43018
    • Volyn Regional Oncological Dispensary
  • Sumy, Ukraine, 40022
    • RMI Sumy Regional Clinical Oncology Dispensary
  • Uzhhorod, Ukraine, 88000
    • Cne Ccch of Uzh Cc Oncological Center
  • Zaporizhzhia, Ukraine, 69059
    • Medical Center Oncolife Llc
• United States
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center
    • Whittier, California, United States, 90603
      • Innovative Clinical Research Institute
  • Pennsylvania
    • Reading, Pennsylvania, United States, 19612
      • Reading Hospital and Medical Center
• Vietnam
  • Can Tho, Vietnam, 00000
    • Can Tho Oncology Hospital
  • Hanoi, Vietnam, 100000
    • Bach Mai Hospital
  • Hanoi, Vietnam, 10000
    • National Lung Hospital
  • Hanoi, Vietnam, 100000
    • National Cancer Hospital
  • Hanoi, Vietnam, 00000
    • 103 Military Hospital
  • Hanoi, Vietnam, 100000
    • Hanoi Oncology Hospital
  • Ho Chi Minh City, Vietnam, 722681
    • Hcmc Oncology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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:

• 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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INCMGA00012 + chemotherapy (nonsquamous NSCLC); INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.	Drug: Retifanlimab; INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.; Other Names: INCMGA00012; 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.
Active Comparator: 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.	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: Placebo; Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Experimental: INCMGA00012 + chemotherapy (squamous NSCLC); INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.	Drug: Retifanlimab; INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.; Other Names: INCMGA00012; 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.
Active Comparator: 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.	Drug: Carboplatin; Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.; Drug: Placebo; Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival was defined as the time between the date of randomization and the date of death due to any cause.	up to 39.1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the length of time from the date of randomization until the earliest date of disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by blinded independent central review (BICR), or death due to any cause, if occurring sooner than progression.	up to 35.8 months
Objective Response Rate	Objective response rate was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 based on BICR at any post-Baseline visit until the first progressive disease or new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.	up to 35.78 months
Duration of Response	Duration of response was defined as the time from the earliest date of documented response until the earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.	up to 34.3 months
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.	up to approximately 39 months
Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.	up to approximately 39 months
Number of Participants With Any TEAE in the Monotherapy Treatment Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.	up to approximately 27 months
Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.	up to approximately 27 months
Cmax1 of Retifanlimab When Administered With Chemotherapy	Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab.	Cycle 1 Day 1: pre-infusion and immediately after infusion
AUC1 of Retifanlimab When Administered With Chemotherapy	AUC1 was defined as the first-dose area under the serum concentration versus time curve.	Cycle 1 Day 1: pre-infusion and immediately after infusion
Cmaxss of Retifanlimab When Administered With Chemotherapy	Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state.	Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.
AUCss of Retifanlimab When Administered With Chemotherapy	AUCss was defined as the area under the serum concentration versus time curve at steady state.	Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Collaborators: Zai Lab (Shanghai) Co., Ltd.
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

General Publications

• 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 Dec;13(12):1096-1107. doi: 10.1016/S2213-2600(25)00209-7. Epub 2025 Sep 19.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): December 15, 2023
• Study Completion (Estimated): August 28, 2026

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; Metastatic; PD-1; PD-L1; squamous; nonsquamous
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; 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; Platinum Compounds; Pemetrexed; Carboplatin; Paclitaxel; Cisplatin; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: INCMGA 0012-304; 2019-003372-39 (EudraCT Number); 2022-501987-16-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No