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

Primary Purpose

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

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Retifanlimab
Placebo
Pemetrexed
Cisplatin
Carboplatin
Paclitaxel
nab-Paclitaxel
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Squamous Non-Small Cell Lung Cancer focused on measuring Metastatic, non-small cell lung cancer, nonsquamous, squamous, PD-1, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pacific Cancer Medical Center
  • Innovative Clinical Research Institute
  • Reading Hospital and Medical Center
  • Fundacao Pio Xii Hospital de Cancer de Barretos
  • Incan - Instituto Do Cancer - Hospital Pompeia
  • Centro Regional Integrado de Oncologia
  • Oncosite - Centro de Pesquisa Clinica E Oncologia
  • Clinica de Neoplasias Litoral Ltda
  • Hospital Do Cancer de Londrina
  • Instituto Mederi de Pesquisa E Saude
  • Hgb - Hospital Giovanni Battista - Mae de Deus Center
  • Inca - Instituto Nacional de Cancer
  • Sao Camilo Oncologia
  • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  • Mc Women'S Health-Nadezhda Eood
  • Acibadem Cityclinica Mhat Tokuda
  • Umhat Sv. Ivan Rilski Ead
  • Mhat Serdika Eood
  • Multiprofile Hospital For Active Treatment Central Onco Hospital Ood
  • Shatod Dr Marko Marko - Varna Ltd
  • Hunan Cancer Hospital
  • The First Affiliated Hospital Sun Yat-Sen University
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Hangzhou Cancer Hospital
  • The First Affiliated Hospital of Zhejiang University
  • Zhejiang Cancer Hospital
  • Harbin Medical University Cancer Hospital
  • University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
  • The Second Hospital of Anhui Medical University
  • Jinan Central Hospital
  • Linyi Cancer Hospital
  • The Second Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Guangxi Medical University
  • Shanghai Chest Hospital
  • General Hospital of Tianjin
  • The Affiliated Cancer Hospital of Xinjiang Medical University
  • Henan Cancer Hostipal
  • Henan Provincial Peoples Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • University Hospital Hradec Kralove
  • Fakultni Nemocnice Olomouc
  • Nemocnice Agel Ostrava - Vitkovice A.S
  • Fakultni Nemocnice V Motole
  • High Technology Hospital Medcenter
  • Jsc Evex Hospitals
  • Archangel St. Michael Multi Profile Clinical Hospital
  • Israel-Georgian Medical Research Clinic Helsicore
  • New Hospitals
  • Medulla Chemotherapy and Immunotherapy Clinic
  • Tbilisi State Medical University First University Clinic
  • High Technology Medical Center, University Clinic
  • Institute of Clinical Oncology Ltd
  • Cancer Research Center Ltd
  • Orszagos Koranyi Tbc Es Pulmonological Intezet
  • Bacs Kiskun Megyei Oktatokorhaz
  • Advanced Medical and Dental Institute Husm
  • University Malaya Medical Centre
  • Hospital Tengku Ampuan Afzan
  • Sarawak General Hospital
  • Beacon Hospital Sdn Bhd
  • Hospital Pulau Pinang
  • Institut Kanser Negara - National Cancer Institute
  • Cebu Doctors University Hospital
  • Davao Doctors Hospital
  • West Visayas State University Medical Center
  • Makati Medical Center
  • Makati Medical Center
  • Philippine General Hospital
  • Asian Hospital and Medical Center
  • The Medical City
  • St. Lukes Medical Center
  • Ko-Med Centra Kliniczne Biala Podlaska
  • Przychodnia Lekarska Komed
  • Centrum Medyczne Plejady
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
  • Przychodnia Med-Polonia Sp. Z O.O.
  • S.C Oncopremium Team S.R.L
  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
  • Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
  • Spitalul Clinic Judetean de Urgenta Constanta
  • S C Oncocenter Oncologie Medicala S R L
  • Oncomed Srl
  • Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
  • Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
  • Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
  • Llc Tonus
  • Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
  • Bhi of Omsk Region Clinical Oncology Dispensary
  • Pavlov First Saint Petersburg State Medical University
  • N.N. Petrov Research Institute of Oncology
  • N.N. Petrov Research Institute of Oncology
  • Sbhi Volgograd Regional Onclogy Dispensary
  • Clinical Center of Serbia
  • Clinical Center Bezanijska Kosa
  • Clinical Center of Serbia
  • Oncomed-System
  • Clinical Center Kragujevac
  • Institute For Pulmonary Diseases of Vojvodina
  • Cape Town Oncology Trials (Pty) Ltd
  • Cancercare Rondebosch Oncology Centre
  • Wits Clinical Research
  • Sandton Oncology Centre
  • University of Pretoria Oncology Department
  • Mary Potter Oncology Centre
  • Acibadem Adana Hospital
  • Adana Sehir Hastanesi
  • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
  • Memorial Ankara Hospital
  • Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
  • Memorial Antalya Hastanesi
  • Trakya Universitesi Tip Fakultesi
  • Gaziantep University Gaziantep Oncology Hospital
  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
  • Medipol University Medical Faculty
  • Izmir Medicalpark Hospital
  • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
  • Inonu Universitesi Turgut Ozal Tip Merkezi
  • Multifield Clinical Hospital No 4
  • Ci Carpathian Clinical Oncological Center
  • Communal Non-Profit Enterprise Regional Center of Oncology
  • V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine
  • Kherson Regional Oncologic Dispensary
  • Pp Ppc Acinus Medical and Diagnostic Centre
  • Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
  • Kyiv City Clinical Oncological Center
  • Medical Center Asklepion Llc
  • Ci of Krc Kyiv Regional Oncologic Dispensary
  • Volyn Regional Oncological Dispensary
  • Rmi Sumy Regional Clinical Oncology Dispensary
  • Cne Ccch of Uzh Cc Oncological Center
  • Medical Center Oncolife Llc
  • Can Tho Oncology Hospital
  • 103 Military Hospital
  • Bach Mai Hospital
  • Hanoi Oncology Hospital
  • National Cancer Hospital
  • National Lung Hospital
  • Hcmc Oncology Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

INCMGA00012 + chemotherapy (nonsquamous NSCLC)

Placebo + chemotherapy (nonsquamous NSCLC)

INCMGA00012 + chemotherapy (squamous NSCLC)

Placebo + chemotherapy (squamous NSCLC)

Arm Description

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

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.

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

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.

Outcomes

Primary Outcome Measures

Overall survival (OS)
Defined as the time from randomization until death due to any cause.

Secondary Outcome Measures

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.
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.
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.
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.
Cmax of INCMGA00012 when administered with chemotherapy
Maximum observed plasma or serum concentration.
AUC of INCMGA00012 when administered with chemotherapy
Area under the plasma or serum concentration curve.

Full Information

First Posted
December 18, 2019
Last Updated
May 2, 2023
Sponsor
Incyte Corporation
Collaborators
Zai Lab (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04205812
Brief Title
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
Acronym
POD1UM-304
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 27, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
Collaborators
Zai Lab (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
583 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INCMGA00012 + chemotherapy (nonsquamous NSCLC)
Arm Type
Experimental
Arm Description
INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
Arm Title
Placebo + chemotherapy (nonsquamous NSCLC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
INCMGA00012 + chemotherapy (squamous NSCLC)
Arm Type
Experimental
Arm Description
INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
Arm Title
Placebo + chemotherapy (squamous NSCLC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Retifanlimab
Other Intervention Name(s)
INCMGA00012
Intervention Description
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
nab-Paclitaxel
Intervention Description
nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
Defined as the time from randomization until death due to any cause.
Time Frame
Approximately 4.5 years.
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Approximately 4.5 years
Title
Objective response rate (ORR)
Description
Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.
Time Frame
Approximately 4.5 years.
Title
Duration of response (DOR)
Description
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.
Time Frame
Approximately 4.5 years.
Title
Number of treatment-emergent adverse events
Description
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.
Time Frame
Approximately 4.5 years.
Title
Cmax of INCMGA00012 when administered with chemotherapy
Description
Maximum observed plasma or serum concentration.
Time Frame
Approximately 4.5 years.
Title
AUC of INCMGA00012 when administered with chemotherapy
Description
Area under the plasma or serum concentration curve.
Time Frame
Up to approximately 4.5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Incyte Medical Monitor
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Cancer Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612
Country
United States
Facility Name
Fundacao Pio Xii Hospital de Cancer de Barretos
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Incan - Instituto Do Cancer - Hospital Pompeia
City
Caxias Do Sul
ZIP/Postal Code
95010-005
Country
Brazil
Facility Name
Centro Regional Integrado de Oncologia
City
Fortaleza
ZIP/Postal Code
60336-045
Country
Brazil
Facility Name
Oncosite - Centro de Pesquisa Clinica E Oncologia
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Clinica de Neoplasias Litoral Ltda
City
Itajai
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Hospital Do Cancer de Londrina
City
Londrina
ZIP/Postal Code
86015-520
Country
Brazil
Facility Name
Instituto Mederi de Pesquisa E Saude
City
Passo Fundo
ZIP/Postal Code
99010-120
Country
Brazil
Facility Name
Hgb - Hospital Giovanni Battista - Mae de Deus Center
City
Porto Alegre
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
Inca - Instituto Nacional de Cancer
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Sao Camilo Oncologia
City
S?O Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
City
Santo Andre
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
City
Sao Jose
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Mc Women'S Health-Nadezhda Eood
City
Sofia
ZIP/Postal Code
01330
Country
Bulgaria
Facility Name
Acibadem Cityclinica Mhat Tokuda
City
Sofia
ZIP/Postal Code
01407
Country
Bulgaria
Facility Name
Umhat Sv. Ivan Rilski Ead
City
Sofia
ZIP/Postal Code
01431
Country
Bulgaria
Facility Name
Mhat Serdika Eood
City
Sofia
ZIP/Postal Code
01632
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment Central Onco Hospital Ood
City
Sofia
ZIP/Postal Code
01797
Country
Bulgaria
Facility Name
Shatod Dr Marko Marko - Varna Ltd
City
Varna
ZIP/Postal Code
09002
Country
Bulgaria
Facility Name
Hunan Cancer Hospital
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
The First Affiliated Hospital Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310001
Country
China
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310002
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230601
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
ZIP/Postal Code
276001
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
General Hospital of Tianjin
City
Tianjing
ZIP/Postal Code
300052
Country
China
Facility Name
The Affiliated Cancer Hospital of Xinjiang Medical University
City
Urumqi
ZIP/Postal Code
830000
Country
China
Facility Name
Henan Cancer Hostipal
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Facility Name
Henan Provincial Peoples Hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50333
Country
Czechia
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Nemocnice Agel Ostrava - Vitkovice A.S
City
Ostrava - Vitkovice
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
Fakultni Nemocnice V Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
High Technology Hospital Medcenter
City
Batumi
ZIP/Postal Code
06000
Country
Georgia
Facility Name
Jsc Evex Hospitals
City
Kutaisi
ZIP/Postal Code
04600
Country
Georgia
Facility Name
Archangel St. Michael Multi Profile Clinical Hospital
City
Tbilisi
ZIP/Postal Code
00102
Country
Georgia
Facility Name
Israel-Georgian Medical Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
00112
Country
Georgia
Facility Name
New Hospitals
City
Tbilisi
ZIP/Postal Code
00114
Country
Georgia
Facility Name
Medulla Chemotherapy and Immunotherapy Clinic
City
Tbilisi
ZIP/Postal Code
00141
Country
Georgia
Facility Name
Tbilisi State Medical University First University Clinic
City
Tbilisi
ZIP/Postal Code
00141
Country
Georgia
Facility Name
High Technology Medical Center, University Clinic
City
Tbilisi
ZIP/Postal Code
00144
Country
Georgia
Facility Name
Institute of Clinical Oncology Ltd
City
Tbilisi
ZIP/Postal Code
00159
Country
Georgia
Facility Name
Cancer Research Center Ltd
City
Tbilisi
ZIP/Postal Code
00177
Country
Georgia
Facility Name
Orszagos Koranyi Tbc Es Pulmonological Intezet
City
Budapest
ZIP/Postal Code
01121
Country
Hungary
Facility Name
Bacs Kiskun Megyei Oktatokorhaz
City
Kecskemet
ZIP/Postal Code
06000
Country
Hungary
Facility Name
Advanced Medical and Dental Institute Husm
City
Kepala Batas
ZIP/Postal Code
13200
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Beacon Hospital Sdn Bhd
City
Petaling Jaya
ZIP/Postal Code
46050
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Institut Kanser Negara - National Cancer Institute
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Cebu Doctors University Hospital
City
Cebu City
ZIP/Postal Code
06000
Country
Philippines
Facility Name
Davao Doctors Hospital
City
Davao City
ZIP/Postal Code
08000
Country
Philippines
Facility Name
West Visayas State University Medical Center
City
Iloilo City
ZIP/Postal Code
05000
Country
Philippines
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
01229
Country
Philippines
Facility Name
Makati Medical Center
City
Makati
ZIP/Postal Code
01229
Country
Philippines
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
01000
Country
Philippines
Facility Name
Asian Hospital and Medical Center
City
Muntinlupa
ZIP/Postal Code
01781
Country
Philippines
Facility Name
The Medical City
City
Pasig City
ZIP/Postal Code
01605
Country
Philippines
Facility Name
St. Lukes Medical Center
City
Quezon City
ZIP/Postal Code
01102
Country
Philippines
Facility Name
Ko-Med Centra Kliniczne Biala Podlaska
City
Biala Podlaska
ZIP/Postal Code
21-500
Country
Poland
Facility Name
Przychodnia Lekarska Komed
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Przychodnia Med-Polonia Sp. Z O.O.
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
S.C Oncopremium Team S.R.L
City
Baia Mare
ZIP/Postal Code
430295
Country
Romania
Facility Name
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
City
Cluj-napoca
ZIP/Postal Code
400132
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Constanta
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
S C Oncocenter Oncologie Medicala S R L
City
Timisoara
ZIP/Postal Code
300166
Country
Romania
Facility Name
Oncomed Srl
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Llc Tonus
City
Nizniy Novgorod
ZIP/Postal Code
603089
Country
Russian Federation
Facility Name
Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
City
Novosibirsk
ZIP/Postal Code
630108
Country
Russian Federation
Facility Name
Bhi of Omsk Region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint-petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
N.N. Petrov Research Institute of Oncology
City
Saint-petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
N.N. Petrov Research Institute of Oncology
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Sbhi Volgograd Regional Onclogy Dispensary
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Clinical Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Oncomed-System
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Institute For Pulmonary Diseases of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Cape Town Oncology Trials (Pty) Ltd
City
Cape Town
ZIP/Postal Code
07570
Country
South Africa
Facility Name
Cancercare Rondebosch Oncology Centre
City
Cape Town
ZIP/Postal Code
07700
Country
South Africa
Facility Name
Wits Clinical Research
City
Johannesburg
ZIP/Postal Code
02193
Country
South Africa
Facility Name
Sandton Oncology Centre
City
Johannesburg
ZIP/Postal Code
02196
Country
South Africa
Facility Name
University of Pretoria Oncology Department
City
Pretoria
ZIP/Postal Code
00002
Country
South Africa
Facility Name
Mary Potter Oncology Centre
City
Pretoria
ZIP/Postal Code
00181
Country
South Africa
Facility Name
Acibadem Adana Hospital
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Adana Sehir Hastanesi
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06105
Country
Turkey
Facility Name
Memorial Ankara Hospital
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Memorial Antalya Hastanesi
City
Antalya
ZIP/Postal Code
07020
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Gaziantep University Gaziantep Oncology Hospital
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Medipol University Medical Faculty
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Izmir Medicalpark Hospital
City
Izmir
ZIP/Postal Code
35530
Country
Turkey
Facility Name
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Inonu Universitesi Turgut Ozal Tip Merkezi
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Multifield Clinical Hospital No 4
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Ci Carpathian Clinical Oncological Center
City
Ivano-frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Communal Non-Profit Enterprise Regional Center of Oncology
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Kherson Regional Oncologic Dispensary
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Pp Ppc Acinus Medical and Diagnostic Centre
City
Kropyvnytskyi
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Medical Center Asklepion Llc
City
Kyiv
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
Ci of Krc Kyiv Regional Oncologic Dispensary
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Volyn Regional Oncological Dispensary
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Rmi Sumy Regional Clinical Oncology Dispensary
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Cne Ccch of Uzh Cc Oncological Center
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Medical Center Oncolife Llc
City
Zaporizhzhia
ZIP/Postal Code
69059
Country
Ukraine
Facility Name
Can Tho Oncology Hospital
City
Can Tho
ZIP/Postal Code
00000
Country
Vietnam
Facility Name
103 Military Hospital
City
Hanoi
ZIP/Postal Code
00000
Country
Vietnam
Facility Name
Bach Mai Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Hanoi Oncology Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
National Cancer Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
National Lung Hospital
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Facility Name
Hcmc Oncology Hospital
City
Ho Chi Minh City
ZIP/Postal Code
722681
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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