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

NCT04205812 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: INCMGA 0012-3042022-501987-16-002019-003372-39
• Study Type: interventional
• Target: 583
• Locations: 17 countries
• Sites: 140

Brief 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).

Conditions

Metastatic Squamous Non-Small Cell Lung Cancer; Metastatic Nonsquamous Non-Small Cell Lung Cancer

Keywords

Metastatic; non-small cell lung cancer; nonsquamous; squamous; PD-1; PD-L1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Progression-free Survival (PFS)

  up to 35.8 months

• Objective Response Rate

  up to 35.78 months

• Duration of Response

  up to 34.3 months

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period

  up to approximately 39 months

• Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period

  up to approximately 39 months

Study Arms (4)

INCMGA00012 + chemotherapy (nonsquamous NSCLC)

EXPERIMENTAL

INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.

Drug: Retifanlimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Placebo + chemotherapy (nonsquamous NSCLC)

ACTIVE COMPARATOR

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: Placebo; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

INCMGA00012 + chemotherapy (squamous NSCLC)

EXPERIMENTAL

INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.

Drug: Retifanlimab; Drug: Carboplatin; Drug: Paclitaxel; Drug: nab-Paclitaxel

Placebo + chemotherapy (squamous NSCLC)

ACTIVE COMPARATOR

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: Placebo; Drug: Carboplatin; Drug: Paclitaxel; Drug: nab-Paclitaxel

Interventions

Retifanlimab DRUG

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

Also known as: INCMGA00012

INCMGA00012 + chemotherapy (nonsquamous NSCLC); INCMGA00012 + chemotherapy (squamous NSCLC)

Placebo DRUG

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

Placebo + chemotherapy (nonsquamous NSCLC); Placebo + chemotherapy (squamous NSCLC)

Pemetrexed DRUG

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

INCMGA00012 + chemotherapy (nonsquamous NSCLC); Placebo + chemotherapy (nonsquamous NSCLC)

Cisplatin DRUG

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

INCMGA00012 + chemotherapy (nonsquamous NSCLC); Placebo + chemotherapy (nonsquamous NSCLC)

Carboplatin DRUG

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

INCMGA00012 + chemotherapy (nonsquamous NSCLC); INCMGA00012 + chemotherapy (squamous NSCLC); Placebo + chemotherapy (nonsquamous NSCLC); Placebo + chemotherapy (squamous NSCLC)

Paclitaxel DRUG

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

INCMGA00012 + chemotherapy (squamous NSCLC); Placebo + chemotherapy (squamous NSCLC)

nab-Paclitaxel DRUG

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

INCMGA00012 + chemotherapy (squamous NSCLC); Placebo + chemotherapy (squamous NSCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (140)

Pacific Cancer Medical Center

Anaheim, California, 92801, United States

Location

Innovative Clinical Research Institute

Whittier, California, 90603, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612, United States

Location

Fundacao Pio Xii Hospital de Cancer de Barretos

Barretos, 14784-400, Brazil

Location

Incan - Instituto Do Cancer - Hospital Pompeia

Caxias do Sul, 95010-005, Brazil

Location

Centro Regional Integrado de Oncologia

Fortaleza, 60336-045, Brazil

Location

Oncosite - Centro de Pesquisa Clinica E Oncologia

Ijuí, 98700-000, Brazil

Location

Clinica de Neoplasias Litoral Ltda

Itajaí, 88301-220, Brazil

Location

Hospital Do Cancer de Londrina

Londrina, 86015-520, Brazil

Location

Instituto Mederi de Pesquisa E Saude

Passo Fundo, 99010-120, Brazil

Location

Hgb - Hospital Giovanni Battista - Mae de Deus Center

Porto Alegre, 90470-340, Brazil

Location

Inca - Instituto Nacional de Cancer

Rio de Janeiro, 20230-130, Brazil

Location

Sao Camilo Oncologia

S?O Paulo, 03102-002, Brazil

Location

Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

Santo André, 09060-870, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José, 15090-000, Brazil

Location

Mc Women'S Health-Nadezhda Eood

Sofia, 01330, Bulgaria

Location

Acibadem Cityclinica Mhat Tokuda

Sofia, 01407, Bulgaria

Location

Umhat Sv. Ivan Rilski Ead

Sofia, 01431, Bulgaria

Location

Mhat Serdika Eood

Sofia, 01632, Bulgaria

Location

Multiprofile Hospital For Active Treatment Central Onco Hospital Ood

Sofia, 01797, Bulgaria

Location

Shatod Dr Marko Marko - Varna Ltd

Varna, 09002, Bulgaria

Location

Hunan Cancer Hospital

Changsha, 410013, China

Location

The First Affiliated Hospital Sun Yat-Sen University

Guangzhou, 510080, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310001, China

Location

Hangzhou Cancer Hospital

Hangzhou, 310002, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

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

Hefei, 230001, China

Location

The Second Hospital of Anhui Medical University

Hefei, 230601, China

Location

Jinan Central Hospital

Jinan, 250013, China

Location

Linyi Cancer Hospital

Linyi, 276001, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, 330006, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, 530021, China

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

General Hospital of Tianjin

Tianjing, 300052, China

Location

The Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, 830000, China

Location

Henan Cancer Hostipal

Zhengzhou, 450003, China

Location

Henan Provincial Peoples Hospital

Zhengzhou, 450003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

University Hospital Hradec Kralove

Hradec Králové, 50333, Czechia

Location

Fakultni Nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Nemocnice Agel Ostrava - Vitkovice A.S

Ostrava - Vitkovice, 703 84, Czechia

Location

Fakultni Nemocnice V Motole

Prague, 150 06, Czechia

Location

High Technology Hospital Medcenter

Batumi, 06000, Georgia

Location

Jsc Evex Hospitals

Kutaisi, 04600, Georgia

Location

Archangel St. Michael Multi Profile Clinical Hospital

Tbilisi, 00102, Georgia

Location

Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, 00112, Georgia

Location

New Hospitals

Tbilisi, 00114, Georgia

Location

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi, 00141, Georgia

Location

Tbilisi State Medical University First University Clinic

Tbilisi, 00141, Georgia

Location

High Technology Medical Center, University Clinic

Tbilisi, 00144, Georgia

Location

Institute of Clinical Oncology Ltd

Tbilisi, 00159, Georgia

Location

Cancer Research Center Ltd

Tbilisi, 00177, Georgia

Location

Orszagos Koranyi Tbc Es Pulmonological Intezet

Budapest, 01121, Hungary

Location

Bacs Kiskun Megyei Oktatokorhaz

Kecskemét, 06000, Hungary

Location

Advanced Medical and Dental Institute Husm

Kepala Batas, 13200, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

Location

Sarawak General Hospital

Kuching, 93586, Malaysia

Location

Beacon Hospital Sdn Bhd

Petaling Jaya, 46050, Malaysia

Location

Hospital Pulau Pinang

Pulau Pinang, 10990, Malaysia

Location

Institut Kanser Negara - National Cancer Institute

Putrajaya, 62250, Malaysia

Location

Cebu Doctors University Hospital

Cebu City, 06000, Philippines

Location

Asian Hospital and Medical Center

City of Muntinlupa, 01781, Philippines

Location

Davao Doctors Hospital

Davao City, 08000, Philippines

Location

West Visayas State University Medical Center

Iloilo City, 05000, Philippines

Location

Makati Medical Center

Makati, 01229, Philippines

Location

Makati Medical Center

Makati City, 01229, Philippines

Location

Philippine General Hospital

Manila, 01000, Philippines

Location

The Medical City

Pasig, 01605, Philippines

Location

St. Lukes Medical Center

Quezon City, 01102, Philippines

Location

Ko-Med Centra Kliniczne Biala Podlaska

Biała Podlaska, 21-500, Poland

Location

Przychodnia Lekarska Komed

Konin, 62-500, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

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

Lodz, 90-242, Poland

Location

Przychodnia Med-Polonia Sp. Z O.O.

Poznan, 60-693, Poland

Location

S.C Oncopremium Team S.R.L

Baia Mare, 430295, Romania

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

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

Cluj-Napoca, 400132, Romania

Location

Spitalul Clinic Judetean de Urgenta Constanta

Constanța, 900591, Romania

Location

S C Oncocenter Oncologie Medicala S R L

Timișoara, 300166, Romania

Location

Oncomed Srl

Timișoara, 300239, Romania

Location

Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, 163045, Russia

Location

Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee

Kursk, 305035, Russia

Location

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

Moscow, 121309, Russia

Location

Llc Tonus

Nizniy Novgorod, 603089, Russia

Location

Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary

Novosibirsk, 630108, Russia

Location

Bhi of Omsk Region Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

N.N. Petrov Research Institute of Oncology

Saint Petersburg, 197758, Russia

Location

Sbhi Volgograd Regional Onclogy Dispensary

Volgograd, 400138, Russia

Location

Clinical Center of Serbia

Belgrade, 11 000, Serbia

Location

Clinical Center Bezanijska Kosa

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Oncomed-System

Belgrade, 11000, Serbia

Location

Institute For Pulmonary Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Cape Town Oncology Trials (Pty) Ltd

Cape Town, 07570, South Africa

Location

Cancercare Rondebosch Oncology Centre

Cape Town, 07700, South Africa

Location

Wits Clinical Research

Johannesburg, 02193, South Africa

Location

Sandton Oncology Centre

Johannesburg, 02196, South Africa

Location

University of Pretoria Oncology Department

Pretoria, 00002, South Africa

Location

Mary Potter Oncology Centre

Pretoria, 00181, South Africa

Location

Acibadem Adana Hospital

Adana, 01130, Turkey (Türkiye)

Location

Adana Sehir Hastanesi

Adana, 01230, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital

Ankara, 06105, Turkey (Türkiye)

Location

Memorial Ankara Hospital

Ankara, 06520, Turkey (Türkiye)

Location

Yildirim Beyazit University Ankara Ataturk Training and Research Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Memorial Antalya Hastanesi

Antalya, 07020, Turkey (Türkiye)

Location

Trakya Universitesi Tip Fakultesi

Edirne, 22030, Turkey (Türkiye)

Location

Gaziantep University Gaziantep Oncology Hospital

Gaziantep, 27310, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

Izmir Medicalpark Hospital

Izmir, 35530, Turkey (Türkiye)

Location

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi

Konya, 42080, Turkey (Türkiye)

Location

Inonu Universitesi Turgut Ozal Tip Merkezi

Malatya, 44280, Turkey (Türkiye)

Location

Multifield Clinical Hospital No 4

Dnipro, 49102, Ukraine

Location

Ci Carpathian Clinical Oncological Center

Ivano-Frankivsk, 76018, Ukraine

Location

Communal Non-Profit Enterprise Regional Center of Oncology

Kharkiv, 61070, Ukraine

Location

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

Kharkiv, 61103, Ukraine

Location

Kherson Regional Oncologic Dispensary

Kherson, 73000, Ukraine

Location

Pp Ppc Acinus Medical and Diagnostic Centre

Kropyvnytskyi, 25006, Ukraine

Location

Mi Kryviy Rih Center of Dnipropetrovsk Regional Council

Kryvyi Rih, 50048, Ukraine

Location

Kyiv City Clinical Oncological Center

Kyiv, 03115, Ukraine

Location

Medical Center Asklepion Llc

Kyiv, 03126, Ukraine

Location

Ci of Krc Kyiv Regional Oncologic Dispensary

Kyiv, 04107, Ukraine

Location

Volyn Regional Oncological Dispensary

Lutsk, 43018, Ukraine

Location

Rmi Sumy Regional Clinical Oncology Dispensary

Sumy, 40022, Ukraine

Location

Cne Ccch of Uzh Cc Oncological Center

Uzhhorod, 88000, Ukraine

Location

Medical Center Oncolife Llc

Zaporizhzhia, 69059, Ukraine

Location

Can Tho Oncology Hospital

Can Tho, 00000, Vietnam

Location

103 Military Hospital

Hanoi, 00000, Vietnam

Location

Bach Mai Hospital

Hanoi, 100000, Vietnam

Location

Hanoi Oncology Hospital

Hanoi, 100000, Vietnam

Location

National Cancer Hospital

Hanoi, 100000, Vietnam

Location

National Lung Hospital

Hanoi, 10000, Vietnam

Location

Hcmc Oncology Hospital

Ho Chi Minh City, 722681, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 40983066 DERIVED

Related Links

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

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Carboplatin; Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 19, 2019
• Study Start: September 11, 2020
• Primary Completion: December 15, 2023
• Study Completion (Estimated): August 28, 2026
• Last Updated: March 31, 2026
• Results First Posted: February 6, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

US (3); PL (5); PH (9); BR (12); CZ (4); SE (6); RO (6); CN (19); HU (2); BU (6); RU (9); TU (15); UA (14); VN (7); MY (7); GE (10); ZA (6)