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M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
M7824
Pembrolizumab
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring M7824, Pembrolizumab, PD-L1-tumor Expression, INTR@PID Lung 037, Bintrafusp alfa

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed diagnosis of advanced NSCLC
  • Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
  • Have measurable disease based on RECIST 1.1
  • Have a life expectancy of at least 3 months
  • Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
  • PD-L1 high status as determined by central testing
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
  • Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study
  • Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations
  • Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
  • Other protocol defined exclusion criteria could apply

Sites / Locations

  • Oncology Specialties, PC; Clearview Cancer Institute
  • Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic
  • UC Irvine Medical Center
  • Kaiser Permanente - Harbor City
  • Sansum Clinic - Santa Barbara
  • Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada
  • Eastern Connecticut Hematology/Oncology Assoc.
  • Cancer Specialists, LLC - Department of Clinical Research
  • Woodlands Medical Specialists
  • The University of Chicago Medical Center
  • Decatur Memorial Hospital - Clinical Research
  • Baptist Health Lexington Oncology Associates
  • Norton Cancer Institute
  • Henry Ford Medical Center
  • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account
  • Southeast Nebraska Cancer Center
  • The Valley Hospital - Luckow Pavilion
  • University of Rochester Medical Center
  • Cleveland Clinic
  • UPMC Cancer Center
  • SCRI - Tennessee Oncology
  • Vanderbilt University Medical Center
  • Texas Oncology - Bedford
  • Texas Oncology, P.A. - Sugarland
  • Virginia Cancer Specialists, PC
  • Centro de Oncologia e Investigacion Buenos Aires
  • Instituto Medico Especializado Alexander Fleming
  • Sanatorio Allende
  • Instituto Medico Rio Cuarto
  • Instituto de Oncología de Rosario
  • Centro Medico San Roque S.R.L.
  • Universitair Ziekenhuis Brussel - Geriatrie
  • Jessa Ziekenhuis Hospital
  • UZ Leuven
  • CHU Mont-Godinne
  • Hospital de Câncer de Barretos - Fundação Pio XII
  • CRIO - Centro Regional Integrado de Oncologia
  • Hospital São Lucas da PUCRS
  • INCA - Instituto Nacional de Câncer
  • NOB - Núcleo de Oncologia da Bahia
  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia - Faculdade de Medicina do ABC
  • Saint John Regional Hospital
  • Tom Baker Cancer Centre
  • Stronach Regional Cancer Centre - at Southlake
  • Peking University Cancer Hospital
  • Guangdong General Hospital
  • Shanghai Cancer Hospital, Fudan University
  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha
  • Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
  • Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire
  • Centre Léon Bérard
  • CHU Rennes - Hopital Pontchaillou - service de pneumologie
  • ICO - Site René Gauducheau
  • CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique
  • Vivantes Klinikum Am Urban - Haematologie und Onkologie
  • Asklepios Fachkliniken Muenchen-Gauting - Abteilung Internistische Onkologie
  • LungenClinic Grosshansdorf
  • Medizinische Hochschule Hannover - Pneumologie
  • Universitaetsklinikum Schleswig- Holstein Campus Luebeck
  • Universitaetsklinikum Regensburg - Klinik und Poliklinik fuer Innere Medizin II
  • 251 General Air Force Hospital
  • General Hospital of Athens of Chest Disease "SOTIRIA"
  • University General Hospital of Heraklion "PAGNI"
  • General Hospital Papageorgiou-2nd Department of Dermatalogy
  • Princess Margaret Hospital
  • The University of Hong Kong
  • The Chinese University of Hong Kong - Emergency Medicine
  • Azienda Ospedaliera San Giuseppe Moscati - U.O Oncologia Medica
  • IRCCS Centro di Riferimento Oncologico - Oncologia Medica A
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Oncologia Medica
  • Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico - Unità Operativa di Oncologia
  • Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario - Centro Oncologico
  • Fondazione IRCCS Istituto Nazionale dei Tumori - Medicina Oncologica I
  • Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia
  • NHO Hokkaido Cancer Center - Dept of Respiratory Medicine
  • National Cancer Center Hospital - Dept of Respiratory Medicine
  • Saitama Medical University International Medical Center - Dept of Respiratory Medicine
  • Saitama Cancer Center
  • Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
  • Kurume University Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Kindai University Hospital
  • Chungbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University
  • Asan Medical Center
  • Samsung Medical Center
  • Antoni van Leeuwenhoek Ziekenhuis
  • VU Medisch Centrum
  • Universitair Medisch Centrum Groningen (UMCG) - Parent
  • Maastricht University Medical Center - Dept of Medical Oncology
  • Erasmus Medisch Centrum
  • St. Elisabeth Ziekenhuis - Parent
  • Hospital del Mar - Servicio de Oncologia
  • Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica
  • Hospital Universitari Vall d'Hebron - Dept of Oncology
  • ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
  • Hospital Universitario 12 de Octubre - Servicio de Oncologia
  • Hospital Regional Universitario de Malaga
  • Hospital Universitario Virgen Macarena - Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio - Servicio de Oncologia
  • Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Tri-Service General Hospital
  • Adana Numune Training and Research Hospital - Cardiology Department
  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Oncology Department
  • Trakya University Medical Faculty - Medical Oncology
  • Kocaeli University Research and Application Hospital
  • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU - Ch of Oncology and MR
  • CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU - Chair of Oncology
  • Communal Non-profit Enterprise Regional Center of Oncology - Parent
  • Medical and Preventive Treatment Institution Volyn Regional Oncological Dispensary - Dept of Oncochemotherapy
  • CCCH City Oncological Center SHEI Uzhgorod NU - Ch of R&O of Faculty of PGE&PUT
  • Medical center "Oncolife"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

M7824

Pembrolizumab

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Overall Survival (OS)
Overall Survival was defined as the time from randomization of study intervention to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention.
Percentage of Participants With Unconfirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Percentage of participants with unconfirmed best overall response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here.
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.

Full Information

First Posted
August 9, 2018
Last Updated
July 14, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03631706
Brief Title
M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title
An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
November 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
M7824, Pembrolizumab, PD-L1-tumor Expression, INTR@PID Lung 037, Bintrafusp alfa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M7824
Arm Type
Experimental
Arm Title
Pembrolizumab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
M7824
Intervention Description
Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab: Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Description
Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time Frame
Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days
Title
Overall Survival (OS)
Description
Overall Survival was defined as the time from randomization of study intervention to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.
Time Frame
Time from randomization of study drug assessed approximately up to 843 days
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Description
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention.
Time Frame
Time from first treatment assessed up to approximately 843 days
Title
Percentage of Participants With Unconfirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Description
Percentage of participants with unconfirmed best overall response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here.
Time Frame
Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days
Title
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Description
DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.
Time Frame
From first documented objective response to PD or death due to any cause, assessed approximately up to 746 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of advanced NSCLC Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications Have measurable disease based on RECIST 1.1 Have a life expectancy of at least 3 months Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment PD-L1 high status as determined by central testing Other protocol defined inclusion criteria could apply Exclusion Criteria: Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years Other protocol defined exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Oncology Specialties, PC; Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Kaiser Permanente - Harbor City
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sansum Clinic - Santa Barbara
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Eastern Connecticut Hematology/Oncology Assoc.
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Cancer Specialists, LLC - Department of Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Woodlands Medical Specialists
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Decatur Memorial Hospital - Clinical Research
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Baptist Health Lexington Oncology Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Southeast Nebraska Cancer Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
The Valley Hospital - Luckow Pavilion
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
SCRI - Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology, P.A. - Sugarland
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Centro de Oncologia e Investigacion Buenos Aires
City
Berazategui
ZIP/Postal Code
B1880BBF
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Instituto Medico Rio Cuarto
City
Rio Cuarto
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Instituto de Oncología de Rosario
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Centro Medico San Roque S.R.L.
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Universitair Ziekenhuis Brussel - Geriatrie
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Jessa Ziekenhuis Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
UZ Leuven
City
Pellenberg
ZIP/Postal Code
3212
Country
Belgium
Facility Name
CHU Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Hospital de Câncer de Barretos - Fundação Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
CRIO - Centro Regional Integrado de Oncologia
City
Fortaleza
ZIP/Postal Code
60336-045
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
INCA - Instituto Nacional de Câncer
City
Rio de Janeiro
ZIP/Postal Code
20230-230
Country
Brazil
Facility Name
NOB - Núcleo de Oncologia da Bahia
City
Salvador
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia - Faculdade de Medicina do ABC
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Saint John Regional Hospital
City
St. John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Tom Baker Cancer Centre
City
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Stronach Regional Cancer Centre - at Southlake
City
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Peking University Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Shanghai Cancer Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
City
Creteil Cedex
State/Province
Val De Marne
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire
City
Bouches-du-Rhône
ZIP/Postal Code
13915
Country
France
Facility Name
Centre Léon Bérard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
CHU Rennes - Hopital Pontchaillou - service de pneumologie
City
Rennes cedex 09
ZIP/Postal Code
35033
Country
France
Facility Name
ICO - Site René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Vivantes Klinikum Am Urban - Haematologie und Onkologie
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Asklepios Fachkliniken Muenchen-Gauting - Abteilung Internistische Onkologie
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
LungenClinic Grosshansdorf
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Medizinische Hochschule Hannover - Pneumologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Schleswig- Holstein Campus Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitaetsklinikum Regensburg - Klinik und Poliklinik fuer Innere Medizin II
City
Regensburg
Country
Germany
Facility Name
251 General Air Force Hospital
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
General Hospital of Athens of Chest Disease "SOTIRIA"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Heraklion "PAGNI"
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
General Hospital Papageorgiou-2nd Department of Dermatalogy
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Princess Margaret Hospital
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong - Emergency Medicine
City
Shatin
ZIP/Postal Code
00000
Country
Hong Kong
Facility Name
Azienda Ospedaliera San Giuseppe Moscati - U.O Oncologia Medica
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
IRCCS Centro di Riferimento Oncologico - Oncologia Medica A
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Oncologia Medica
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico - Unità Operativa di Oncologia
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario - Centro Oncologico
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori - Medicina Oncologica I
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
NHO Hokkaido Cancer Center - Dept of Respiratory Medicine
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
National Cancer Center Hospital - Dept of Respiratory Medicine
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Saitama Medical University International Medical Center - Dept of Respiratory Medicine
City
Hidaka-shi
Country
Japan
Facility Name
Saitama Cancer Center
City
Kitaadachigun
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-sh
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Antoni van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen (UMCG) - Parent
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastricht University Medical Center - Dept of Medical Oncology
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
St. Elisabeth Ziekenhuis - Parent
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Hospital del Mar - Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron - Dept of Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre - Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena - Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Adana Numune Training and Research Hospital - Cardiology Department
City
Adana
ZIP/Postal Code
01370
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Oncology Department
City
Ankara
ZIP/Postal Code
06105
Country
Turkey
Facility Name
Trakya University Medical Faculty - Medical Oncology
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Kocaeli University Research and Application Hospital
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU - Ch of Oncology and MR
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU - Chair of Oncology
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Communal Non-profit Enterprise Regional Center of Oncology - Parent
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Medical and Preventive Treatment Institution Volyn Regional Oncological Dispensary - Dept of Oncochemotherapy
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
CCCH City Oncological Center SHEI Uzhgorod NU - Ch of R&O of Faculty of PGE&PUT
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Medical center "Oncolife"
City
Zaporizhzhia
ZIP/Postal Code
69059
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD Sharing Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD Sharing Access Criteria
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
IPD Sharing URL
http://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200647_0037
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

Learn more about this trial

M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

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