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

Contacts and Locations

Study Locations

• Brazil
  • Barretos, Brazil, 14784-400
    • Fundacao Pio Xii Hospital de Cancer de Barretos
  • Caxias Do Sul, Brazil, 95010-005
    • INCAN - Instituto do Cancer - Hospital Pompeia
  • Fortaleza, Brazil, 60336-045
    • Centro Regional Integrado de Oncologia
  • Ijui, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clinica E Oncologia
  • Itajai, Brazil, 88301-220
    • Clínica de Neoplasias Litoral Ltda
  • Londrina, Brazil, 86015-520
    • Hospital do Câncer de Londrina
  • Passo Fundo, Brazil, 99010-120
    • Instituto Méderi de Pesquisa e Saúde
  • 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 Andre, Brazil, 09060-870
    • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
  • Sao Jose, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose 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
  • Urumqi, China, 830000
    • The Affiliated Cancer Hospital of XinJiang Medical University
  • Zhengzhou, China, 450052
    • The First Affiliated hospital of Zhengzhou University
  • Zhengzhou, China, 450003
    • Henan Cancer Hostipal
  • Zhengzhou, China, 450003
    • Henan Provincial Peoples Hospital
• Czechia
  • Hradec Kralove, Czechia, 50333
    • University Hospital Hradec Kralove
  • Olomouc, Czechia, 775 20
    • Fakultni Nemocnice Olomouc
  • Ostrava - Vitkovice, Czechia, 703 84
    • Nemocnice AGEL Ostrava - Vitkovice a.s
  • Praha 5, 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
  • Kecskemet, 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
  • 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
  • Muntinlupa, Philippines, 01781
    • Asian Hospital and Medical Center
  • Pasig City, Philippines, 01605
    • The Medical City
  • Quezon City, Philippines, 01102
    • St. Lukes Medical Center
• Poland
  • Biala 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
  • Constanta, Romania, 900591
    • Spitalul Clinic Judetean de Urgenta Constanta
  • Timisoara, Romania, 300239
    • Oncomed Srl
  • Timisoara, Romania, 300166
    • S C Oncocenter Oncologie Medicala S R L
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
  • Kursk, Russian Federation, 305035
    • Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
  • Moscow, Russian Federation, 121309
    • Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
  • Nizniy Novgorod, Russian Federation, 603089
    • LLC Tonus
  • Novosibirsk, Russian Federation, 630108
    • Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region Clinical Oncology Dispensary
  • Saint-petersburg, Russian Federation, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Saint-petersburg, Russian Federation, 197758
    • N.N. Petrov Research Institute of Oncology
  • St Petersburg, Russian Federation, 197758
    • N.N. Petrov Research Institute of Oncology
  • Volgograd, Russian Federation, 400138
    • Sbhi Volgograd Regional Onclogy Dispensary
• Serbia
  • Belgrad, Serbia, 11000
    • Oncomed-System
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11 000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center Bezanijska Kosa
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Sremska Kamenica, Serbia, 21204
    • Institute For Pulmonary Diseases of Vojvodina
• 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
  • Adana, Turkey, 01130
    • Acibadem Adana Hospital
  • Adana, Turkey, 01230
    • Adana Sehir Hastanesi
  • Ankara, Turkey, 06100
    • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 06105
    • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
  • Ankara, Turkey, 06520
    • Memorial Ankara Hospital
  • Ankara, Turkey, 06800
    • Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
  • Antalya, Turkey, 07020
    • Memorial Antalya Hastanesi
  • Edirne, Turkey, 22030
    • Trakya Universitesi Tip Fakultesi
  • Gaziantep, Turkey, 27310
    • Gaziantep University Gaziantep Oncology Hospital
  • Istanbul, Turkey, 34214
    • Medipol University Medical Faculty
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 34147
    • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
  • Izmir, Turkey, 35530
    • Izmir Medicalpark Hospital
  • Konya, Turkey, 42080
    • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
  • Malatya, Turkey, 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
  • Uzhgorod, 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
    • Cần Thơ 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 (OS)	Defined as the time from randomization until death due to any cause.	Approximately 4.5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Defined as the time from randomization until 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.	Approximately 4.5 years
Objective response rate (ORR)	Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.	Approximately 4.5 years.
Duration of response (DOR)	Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.	Approximately 4.5 years.
Number of treatment-emergent adverse events	Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.	Approximately 4.5 years.
Cmax of INCMGA00012 when administered with chemotherapy	Maximum observed plasma or serum concentration.	Approximately 4.5 years.
AUC of INCMGA00012 when administered with chemotherapy	Area under the plasma or serum concentration curve.	Up to approximately 4.5 years.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): April 15, 2025

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 (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; Metastatic; PD-1; PD-L1; squamous; nonsquamous
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Folic Acid Antagonists; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel; Pemetrexed
• Other Study ID Numbers: INCMGA 0012-304

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