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Immunotherapy combo shows promise in advanced lung cancer trial

NCT ID NCT04205812

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 07, 2026 · Updated 4 times

Summary

This phase 3 study tested whether adding the immunotherapy drug retifanlimab (INCMGA00012) to standard platinum-based chemotherapy helps people with advanced non-small cell lung cancer live longer. The trial enrolled 583 patients who had not received prior treatment for metastatic disease. Researchers measured overall survival and progression-free survival to see if the combination works better than chemotherapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Retifanlimab (also called INCMGA00012), a type of immunotherapy, given with standard chemotherapy drugs (pemetrexed, cisplatin, carboplatin, paclitaxel)
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with advanced lung cancer, potentially improving how long they live and delaying disease progression.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely available. Immunotherapies can cause immune-related side effects, and not all patients may benefit. The study also excludes some common patient groups, so findings may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

583 people

The number who actually took part.

Started

Sep 2020

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic nonsquamous non-small cell lung cancer Metastatic squamous non-small cell lung cancer

Contacts and locations

Locations

  • 103 Military Hospital

    Hanoi, 00000, Vietnam

  • Acibadem Adana Hospital

    Adana, 01130, Turkey (Türkiye)

  • Acibadem Cityclinica Mhat Tokuda

    Sofia, 01407, Bulgaria

  • Adana Sehir Hastanesi

    Adana, 01230, Turkey (Türkiye)

  • Advanced Medical and Dental Institute Husm

    Kepala Batas, 13200, Malaysia

  • Archangel St. Michael Multi Profile Clinical Hospital

    Tbilisi, 00102, Georgia

  • Asian Hospital and Medical Center

    City of Muntinlupa, 01781, Philippines

  • Bach Mai Hospital

    Hanoi, 100000, Vietnam

  • Bacs Kiskun Megyei Oktatokorhaz

    Kecskemét, 06000, Hungary

  • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital

    Istanbul, 34147, Turkey (Türkiye)

  • Beacon Hospital Sdn Bhd

    Petaling Jaya, 46050, Malaysia

  • Bhi of Omsk Region Clinical Oncology Dispensary

    Omsk, 644013, Russia

  • Can Tho Oncology Hospital

    Can Tho, 00000, Vietnam

  • Cancer Research Center Ltd

    Tbilisi, 00177, Georgia

  • Cancercare Rondebosch Oncology Centre

    Cape Town, 07700, South Africa

  • Cape Town Oncology Trials (Pty) Ltd

    Cape Town, 07570, South Africa

  • Cebu Doctors University Hospital

    Cebu City, 06000, Philippines

  • Centro Regional Integrado de Oncologia

    Fortaleza, 60336-045, Brazil

  • Centrum Medyczne Plejady

    Krakow, 30-363, Poland

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

    Lodz, 90-242, Poland

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

    Santo André, 09060-870, Brazil

  • Ci Carpathian Clinical Oncological Center

    Ivano-Frankivsk, 76018, Ukraine

  • Ci of Krc Kyiv Regional Oncologic Dispensary

    Kyiv, 04107, Ukraine

  • Clinica de Neoplasias Litoral Ltda

    Itajaí, 88301-220, Brazil

  • Clinical Center Bezanijska Kosa

    Belgrade, 11000, Serbia

  • Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • Clinical Center of Serbia

    Belgrade, 11 000, Serbia

  • Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Cne Ccch of Uzh Cc Oncological Center

    Uzhhorod, 88000, Ukraine

  • Communal Non-Profit Enterprise Regional Center of Oncology

    Kharkiv, 61070, Ukraine

  • Davao Doctors Hospital

    Davao City, 08000, Philippines

  • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital

    Ankara, 06105, Turkey (Türkiye)

  • Fakultni Nemocnice Olomouc

    Olomouc, 775 20, Czechia

  • Fakultni Nemocnice V Motole

    Prague, 150 06, Czechia

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

    Moscow, 121309, Russia

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

    São José, 15090-000, Brazil

  • Fundacao Pio Xii Hospital de Cancer de Barretos

    Barretos, 14784-400, Brazil

  • Gaziantep University Gaziantep Oncology Hospital

    Gaziantep, 27310, Turkey (Türkiye)

  • General Hospital of Tianjin

    Tianjing, 300052, China

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100, Turkey (Türkiye)

  • Hangzhou Cancer Hospital

    Hangzhou, 310002, China

  • Hanoi Oncology Hospital

    Hanoi, 100000, Vietnam

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Hcmc Oncology Hospital

    Ho Chi Minh City, 722681, Vietnam

  • Henan Cancer Hostipal

    Zhengzhou, 450003, China

  • Henan Provincial Peoples Hospital

    Zhengzhou, 450003, China

  • Hgb - Hospital Giovanni Battista - Mae de Deus Center

    Porto Alegre, 90470-340, Brazil

  • High Technology Hospital Medcenter

    Batumi, 06000, Georgia

  • High Technology Medical Center, University Clinic

    Tbilisi, 00144, Georgia

  • Hospital Do Cancer de Londrina

    Londrina, 86015-520, Brazil

  • Hospital Pulau Pinang

    Pulau Pinang, 10990, Malaysia

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100, Malaysia

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • Inca - Instituto Nacional de Cancer

    Rio de Janeiro, 20230-130, Brazil

  • Incan - Instituto Do Cancer - Hospital Pompeia

    Caxias do Sul, 95010-005, Brazil

  • Innovative Clinical Research Institute

    Whittier, California, 90603, United States

  • Inonu Universitesi Turgut Ozal Tip Merkezi

    Malatya, 44280, Turkey (Türkiye)

  • Institut Kanser Negara - National Cancer Institute

    Putrajaya, 62250, Malaysia

  • Institute For Pulmonary Diseases of Vojvodina

    Kamenitz, 21204, Serbia

  • Institute of Clinical Oncology Ltd

    Tbilisi, 00159, Georgia

  • Instituto Mederi de Pesquisa E Saude

    Passo Fundo, 99010-120, Brazil

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

    Cluj-Napoca, 400015, Romania

  • Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi, 00112, Georgia

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098, Turkey (Türkiye)

  • Izmir Medicalpark Hospital

    Izmir, 35530, Turkey (Türkiye)

  • Jinan Central Hospital

    Jinan, 250013, China

  • Jsc Evex Hospitals

    Kutaisi, 04600, Georgia

  • Kherson Regional Oncologic Dispensary

    Kherson, 73000, Ukraine

  • Ko-Med Centra Kliniczne Biala Podlaska

    Biała Podlaska, 21-500, Poland

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115, Ukraine

  • Linyi Cancer Hospital

    Linyi, 276001, China

  • Llc Tonus

    Nizniy Novgorod, 603089, Russia

  • Makati Medical Center

    Makati, 01229, Philippines

  • Makati Medical Center

    Makati City, 01229, Philippines

  • Mary Potter Oncology Centre

    Pretoria, 00181, South Africa

  • Mc Women'S Health-Nadezhda Eood

    Sofia, 01330, Bulgaria

  • Medical Center Asklepion Llc

    Kyiv, 03126, Ukraine

  • Medical Center Oncolife Llc

    Zaporizhzhia, 69059, Ukraine

  • Medipol University Medical Faculty

    Istanbul, 34214, Turkey (Türkiye)

  • Medulla Chemotherapy and Immunotherapy Clinic

    Tbilisi, 00141, Georgia

  • Memorial Ankara Hospital

    Ankara, 06520, Turkey (Türkiye)

  • Memorial Antalya Hastanesi

    Antalya, 07020, Turkey (Türkiye)

  • Mhat Serdika Eood

    Sofia, 01632, Bulgaria

  • Mi Kryviy Rih Center of Dnipropetrovsk Regional Council

    Kryvyi Rih, 50048, Ukraine

  • Multifield Clinical Hospital No 4

    Dnipro, 49102, Ukraine

  • Multiprofile Hospital For Active Treatment Central Onco Hospital Ood

    Sofia, 01797, Bulgaria

  • N.N. Petrov Research Institute of Oncology

    Saint Petersburg, 197758, Russia

  • National Cancer Hospital

    Hanoi, 100000, Vietnam

  • National Lung Hospital

    Hanoi, 10000, Vietnam

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi

    Konya, 42080, Turkey (Türkiye)

  • Nemocnice Agel Ostrava - Vitkovice A.S

    Ostrava - Vitkovice, 703 84, Czechia

  • New Hospitals

    Tbilisi, 00114, Georgia

  • Oncomed Srl

    Timișoara, 300239, Romania

  • Oncomed-System

    Belgrade, 11000, Serbia

  • Oncosite - Centro de Pesquisa Clinica E Oncologia

    Ijuí, 98700-000, Brazil

  • Orszagos Koranyi Tbc Es Pulmonological Intezet

    Budapest, 01121, Hungary

  • Pacific Cancer Medical Center

    Anaheim, California, 92801, United States

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022, Russia

  • Philippine General Hospital

    Manila, 01000, Philippines

  • Pp Ppc Acinus Medical and Diagnostic Centre

    Kropyvnytskyi, 25006, Ukraine

  • Przychodnia Lekarska Komed

    Konin, 62-500, Poland

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

    Poznan, 60-693, Poland

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

    Kursk, 305035, Russia

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612, United States

  • Rmi Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022, Ukraine

  • S C Oncocenter Oncologie Medicala S R L

    Timișoara, 300166, Romania

  • S.C Oncopremium Team S.R.L

    Baia Mare, 430295, Romania

  • Sandton Oncology Centre

    Johannesburg, 02196, South Africa

  • Sao Camilo Oncologia

    S?O Paulo, 03102-002, Brazil

  • Sarawak General Hospital

    Kuching, 93586, Malaysia

  • Sbhi Volgograd Regional Onclogy Dispensary

    Volgograd, 400138, Russia

  • Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary

    Novosibirsk, 630108, Russia

  • Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045, Russia

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shatod Dr Marko Marko - Varna Ltd

    Varna, 09002, Bulgaria

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310001, China

  • Spitalul Clinic Judetean de Urgenta Constanta

    Constanța, 900591, Romania

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

    Cluj-Napoca, 400132, Romania

  • St. Lukes Medical Center

    Quezon City, 01102, Philippines

  • Tbilisi State Medical University First University Clinic

    Tbilisi, 00141, Georgia

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, 830000, China

  • The First Affiliated Hospital Sun Yat-Sen University

    Guangzhou, 510080, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021, China

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052, China

  • The Medical City

    Pasig, 01605, Philippines

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330006, China

  • The Second Hospital of Anhui Medical University

    Hefei, 230601, China

  • Trakya Universitesi Tip Fakultesi

    Edirne, 22030, Turkey (Türkiye)

  • Umhat Sv. Ivan Rilski Ead

    Sofia, 01431, Bulgaria

  • University Hospital Hradec Kralove

    Hradec Králové, 50333, Czechia

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University of Pretoria Oncology Department

    Pretoria, 00002, South Africa

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

    Hefei, 230001, China

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

    Kharkiv, 61103, Ukraine

  • Volyn Regional Oncological Dispensary

    Lutsk, 43018, Ukraine

  • West Visayas State University Medical Center

    Iloilo City, 05000, Philippines

  • Wits Clinical Research

    Johannesburg, 02193, South Africa

  • Yildirim Beyazit University Ankara Ataturk Training and Research Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

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Other studies related to the condition(s) this trial covers.