AzTrials
AzTrials

Metastatic Squamous Non-Small Cell Lung CancerPhase 3POD1UM-304NCT04205812

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

A Phase 3 study testing Retifanlimab, Pemetrexed and Cisplatin in people with Metastatic Squamous Non-Small Cell Lung Cancer and Metastatic Nonsquamous Non-Small Cell Lung Cancer, run by Incyte Corporation at 140 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Retifanlimab, Pemetrexed and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
583 participants
Where
140 sitesin 17 countries
Study dates
11 Sep 2020to 28 May 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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)

Trial locations and contacts

140 sites in 17 countries.

140 sites in 17 countries

China19 sites

  • Hunan Cancer Hospital

    Changsha, 410013

  • The First Affiliated Hospital Sun Yat-Sen University

    Guangzhou, 510080

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310001

  • Hangzhou Cancer Hospital

    Hangzhou, 310002

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

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

    Hefei, 230001

  • The Second Hospital of Anhui Medical University

    Hefei, 230601

  • Jinan Central Hospital

    Jinan, 250013

  • Linyi Cancer Hospital

    Linyi, 276001

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

  • Shanghai Chest Hospital

    Shanghai, 200030

  • General Hospital of Tianjin

    Tianjing, 300052

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, 830000

  • Henan Cancer Hostipal

    Zhengzhou, 450003

  • Henan Provincial Peoples Hospital

    Zhengzhou, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Turkey (Türkiye)15 sites

  • Acibadem Adana Hospital

    Adana, 01130

  • Adana Sehir Hastanesi

    Adana, 01230

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100

  • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital

    Ankara, 06105

  • Memorial Ankara Hospital

    Ankara, 06520

  • Yildirim Beyazit University Ankara Ataturk Training and Research Hospital

    Ankara, 06800

  • Memorial Antalya Hastanesi

    Antalya, 07020

  • Trakya Universitesi Tip Fakultesi

    Edirne, 22030

  • Gaziantep University Gaziantep Oncology Hospital

    Gaziantep, 27310

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital

    Istanbul, 34147

  • Medipol University Medical Faculty

    Istanbul, 34214

  • Izmir Medicalpark Hospital

    Izmir, 35530

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi

    Konya, 42080

  • Inonu Universitesi Turgut Ozal Tip Merkezi

    Malatya, 44280

Other trials in Turkey (Türkiye)

Ukraine14 sites

  • Multifield Clinical Hospital No 4

    Dnipro, 49102

  • Ci Carpathian Clinical Oncological Center

    Ivano-Frankivsk, 76018

  • Communal Non-Profit Enterprise Regional Center of Oncology

    Kharkiv, 61070

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

    Kharkiv, 61103

  • Kherson Regional Oncologic Dispensary

    Kherson, 73000

  • Pp Ppc Acinus Medical and Diagnostic Centre

    Kropyvnytskyi, 25006

  • Mi Kryviy Rih Center of Dnipropetrovsk Regional Council

    Kryvyi Rih, 50048

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115

  • Medical Center Asklepion Llc

    Kyiv, 03126

  • Ci of Krc Kyiv Regional Oncologic Dispensary

    Kyiv, 04107

  • Volyn Regional Oncological Dispensary

    Lutsk, 43018

  • Rmi Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022

  • Cne Ccch of Uzh Cc Oncological Center

    Uzhhorod, 88000

  • Medical Center Oncolife Llc

    Zaporizhzhya, 69059

Other trials in Ukraine

Brazil12 sites

  • Fundacao Pio Xii Hospital de Cancer de Barretos

    Barretos, 14784-400

  • Incan - Instituto Do Cancer - Hospital Pompeia

    Caxias do Sul, 95010-005

  • Centro Regional Integrado de Oncologia

    Fortaleza, 60336-045

  • Oncosite - Centro de Pesquisa Clinica E Oncologia

    Ijuí, 98700-000

  • Clinica de Neoplasias Litoral Ltda

    Itajaí, 88301-220

  • Hospital Do Cancer de Londrina

    Londrina, 86015-520

  • Instituto Mederi de Pesquisa E Saude

    Passo Fundo, 99010-120

  • Hgb - Hospital Giovanni Battista - Mae de Deus Center

    Porto Alegre, 90470-340

  • Inca - Instituto Nacional de Cancer

    Rio de Janeiro, 20230-130

  • Sao Camilo Oncologia

    S?O Paulo, 03102-002

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

    Santo André, 09060-870

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

    São José, 15090-000

Other trials in Brazil

Georgia10 sites

  • High Technology Hospital Medcenter

    Batumi, 06000

  • Jsc Evex Hospitals

    Kutaisi, 04600

  • Archangel St. Michael Multi Profile Clinical Hospital

    Tbilisi, 00102

  • Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi, 00112

  • New Hospitals

    Tbilisi, 00114

  • Medulla Chemotherapy and Immunotherapy Clinic

    Tbilisi, 00141

  • Tbilisi State Medical University First University Clinic

    Tbilisi, 00141

  • High Technology Medical Center, University Clinic

    Tbilisi, 00144

  • Institute of Clinical Oncology Ltd

    Tbilisi, 00159

  • Cancer Research Center Ltd

    Tbilisi, 00177

Other trials in Georgia

Philippines9 sites

  • Cebu Doctors University Hospital

    Cebu City, 06000

  • Asian Hospital and Medical Center

    City of Muntinlupa, 01781

  • Davao Doctors Hospital

    Davao City, 08000

  • West Visayas State University Medical Center

    Iloilo City, 05000

  • Makati Medical Center

    Makati, 01229

  • Makati Medical Center

    Makati City, 01229

  • Philippine General Hospital

    Manila, 01000

  • The Medical City

    Pasig, 01605

  • St. Lukes Medical Center

    Quezon City, 01102

Other trials in Philippines

Russia9 sites

  • Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045

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

    Kursk, 305035

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

    Moscow, 121309

  • Llc Tonus

    Nizniy Novgorod, 603089

  • Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary

    Novosibirsk, 630108

  • Bhi of Omsk Region Clinical Oncology Dispensary

    Omsk, 644013

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • N.N. Petrov Research Institute of Oncology

    Saint Petersburg, 197758

  • Sbhi Volgograd Regional Onclogy Dispensary

    Volgograd, 400138

Other trials in Russia

Malaysia7 sites

  • Advanced Medical and Dental Institute Husm

    Kepala Batas, 13200

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Sarawak General Hospital

    Kuching, 93586

  • Beacon Hospital Sdn Bhd

    Petaling Jaya, 46050

  • Hospital Pulau Pinang

    Pulau Pinang, 10990

  • Institut Kanser Negara - National Cancer Institute

    Putrajaya, 62250

Other trials in Malaysia

Vietnam7 sites

  • Can Tho Oncology Hospital

    Can Tho, 00000

  • 103 Military Hospital

    Hanoi, 00000

  • Bach Mai Hospital

    Hanoi, 100000

  • Hanoi Oncology Hospital

    Hanoi, 100000

  • National Cancer Hospital

    Hanoi, 100000

  • National Lung Hospital

    Hanoi, 10000

  • Hcmc Oncology Hospital

    Ho Chi Minh City, 722681

Other trials in Vietnam

Bulgaria6 sites

  • Mc Women'S Health-Nadezhda Eood

    Sofia, 01330

  • Acibadem Cityclinica Mhat Tokuda

    Sofia, 01407

  • Umhat Sv. Ivan Rilski Ead

    Sofia, 01431

  • Mhat Serdika Eood

    Sofia, 01632

  • Multiprofile Hospital For Active Treatment Central Onco Hospital Ood

    Sofia, 01797

  • Shatod Dr Marko Marko - Varna Ltd

    Varna, 09002

Other trials in Bulgaria

Romania6 sites

  • S.C Oncopremium Team S.R.L

    Baia Mare, 430295

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

    Cluj-Napoca, 400015

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

    Cluj-Napoca, 400132

  • Spitalul Clinic Judetean de Urgenta Constanta

    Constanța, 900591

  • S C Oncocenter Oncologie Medicala S R L

    Timișoara, 300166

  • Oncomed Srl

    Timișoara, 300239

Other trials in Romania

Serbia6 sites

  • Clinical Center of Serbia

    Belgrade, 11 000

  • Clinical Center Bezanijska Kosa

    Belgrade, 11000

  • Clinical Center of Serbia

    Belgrade, 11000

  • Oncomed-System

    Belgrade, 11000

  • Institute For Pulmonary Diseases of Vojvodina

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

South Africa6 sites

  • Cape Town Oncology Trials (Pty) Ltd

    Cape Town, 07570

  • Cancercare Rondebosch Oncology Centre

    Cape Town, 07700

  • Wits Clinical Research

    Johannesburg, 02193

  • Sandton Oncology Centre

    Johannesburg, 02196

  • University of Pretoria Oncology Department

    Pretoria, 00002

  • Mary Potter Oncology Centre

    Pretoria, 00181

Other trials in South Africa

Poland5 sites

  • Ko-Med Centra Kliniczne Biala Podlaska

    Biała Podlaska, 21-500

  • Przychodnia Lekarska Komed

    Konin, 62-500

  • Centrum Medyczne Plejady

    Krakow, 30-363

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

    Lodz, 90-242

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

    Poznan, 60-693

Other trials in Poland

Czechia4 sites

  • University Hospital Hradec Kralove

    Hradec Králové, 50333

  • Fakultni Nemocnice Olomouc

    Olomouc, 775 20

  • Nemocnice Agel Ostrava - Vitkovice A.S

    Ostrava - Vitkovice, 703 84

  • Fakultni Nemocnice V Motole

    Prague, 150 06

Other trials in Czechia

United States3 sites

  • Pacific Cancer Medical Center

    Anaheim, California, 92801

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Hungary2 sites

  • Orszagos Koranyi Tbc Es Pulmonological Intezet

    Budapest, 01121

  • Bacs Kiskun Megyei Oktatokorhaz

    Kecskemét, 06000

Other trials in Hungary

About this study

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)

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).

Being tested
Retifanlimab, Placebo, Pemetrexed, Cisplatin, Carboplatin
Keywords
Metastatic, non-small cell lung cancer, nonsquamous, squamous, PD-1, PD-L1
Medical subject headings
Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetifanlimabDrug

    Also called INCMGA00012

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

  • PlaceboDrug

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

  • PemetrexedDrug

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

  • CisplatinDrug

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

  • CarboplatinDrug

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

  • PaclitaxelDrug

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

  • nab-PaclitaxelDrug

    nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.

Study groups in NCT04205812
Study groupRoleWhat they receive
INCMGA00012 + chemotherapy (nonsquamous NSCLC)ExperimentalINCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
Receives: Drug: Retifanlimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Placebo + chemotherapy (nonsquamous NSCLC)Active comparatorPlacebo 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.
Receives: Drug: Placebo; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
INCMGA00012 + chemotherapy (squamous NSCLC)ExperimentalINCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
Receives: Drug: Retifanlimab; Drug: Carboplatin; Drug: Paclitaxel; Drug: nab-Paclitaxel
Placebo + chemotherapy (squamous NSCLC)Active comparatorPlacebo 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.
Receives: Drug: Placebo; Drug: Carboplatin; Drug: Paclitaxel; Drug: nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival was defined as the time between the date of randomization and the date of death due to any cause.

    Measured: up to 39.1 months

Secondary outcomes (11)

  1. 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.

    Measured: up to 35.8 months

  2. 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.

    Measured: up to 35.78 months

  3. 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.

    Measured: up to 34.3 months

  4. 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.

    Measured: up to approximately 39 months

  5. 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.

    Measured: up to approximately 39 months

  6. 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.

    Measured: up to approximately 27 months

  7. 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.

    Measured: up to approximately 27 months

  8. Cmax1 of Retifanlimab When Administered With Chemotherapy

    Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab.

    Measured: Cycle 1 Day 1: pre-infusion and immediately after infusion

  9. AUC1 of Retifanlimab When Administered With Chemotherapy

    AUC1 was defined as the first-dose area under the serum concentration versus time curve.

    Measured: Cycle 1 Day 1: pre-infusion and immediately after infusion

  10. Cmaxss of Retifanlimab When Administered With Chemotherapy

    Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state.

    Measured: 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.

  11. AUCss of Retifanlimab When Administered With Chemotherapy

    AUCss was defined as the area under the serum concentration versus time curve at steady state.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start11 Sep 2020
  3. Primary completion15 Dec 2023
  4. Study completion28 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
583 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04205812
Sponsor's protocol ID
INCMGA 0012-304
Other IDs
2022-501987-16-00, 2019-003372-39, 2019
Acronym
POD1UM-304
Status last verified
May 2026
First submitted
18 Dec 2019
Last updated
6 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

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.

    PubMed 40983066

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retifanlimab, Pemetrexed and Cisplatin in people with Metastatic Squamous Non-Small Cell Lung Cancer and Metastatic Nonsquamous Non-Small Cell Lung Cancer, run by Incyte Corporation at 140 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in China, Turkey (Türkiye), Ukraine, Brazil, Georgia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: up to 39.1 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04205812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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