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M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
M7824
Placebo
Durvalumab
Etoposide
Pemetrexed
Carboplatin
Paclitaxel
Cisplatin
Intensity Modulated Radiation Therapy (IMRT)
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 Non-small Cell Lung Cancer, Bintrafusp alfa (proposed INN), M7824, Durvalumab, Stage III, INTR@PID LUNG 005

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
  • Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible.
  • Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of predicted normal volume measured within 3 weeks prior to randomization.
  • Adequate hematological, hepatic and renal function as defined in the protocol
  • Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies

Exclusion Criteria:

  • Participants with Mixed small cell with non-small cell lung cancer histology
  • Recent major surgery within 4 weeks prior to entry into the study
  • Significant acute or chronic infections including human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and active tuberculosis
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization
  • Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
  • Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug targeting T-cell coregulatory proteins

Sites / Locations

  • University of California Irvine Medical Center
  • UCLA Hematology Oncology - Main Site - 2020 Santa Monica
  • University of Colorado Health - Memorial Hospital - Memorial Hospital
  • Hematology Oncology Associates
  • Lynn Cancer Institute Center
  • Holy Cross Hospital - Michael and Dianne Bienes CCC
  • Sylvester Comprehensive Cancer Center - University of Miami Health System
  • The University of Chicago Medical Center
  • American Health Network of Indiana, LLC
  • Franciscan St. Francis Health Cancer Center
  • Baptist Health Lexington Oncology Associates
  • University of Maryland - DUPLICATE/Pediatric Surgery
  • Henry Ford Health System
  • Mayo Clinic
  • Columbia University Medical Center
  • Hematology Oncology Center of Nyack Hospital
  • FirstHealth of the Carolinas, Inc.
  • The James Cancer Hospital and Solove Research Institute
  • UPMC Cancer Center
  • Vanderbilt University Medical Center
  • University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology
  • Sanatorio Allende
  • Centro Polivalente de Asistencia e Inv. Clinica CER
  • Bendigo Hospital
  • The Townsville Hospital
  • Calvary Central Districts Hospital
  • St Vincent's Hospital Melbourne - PARENT
  • University Hospital Geelong - PARENT
  • Austin Health
  • Centro de Investigacion Pergamino SA
  • Prince of Wales Hospital
  • Sunshine Hospital
  • Royal North Shore Hospital
  • South West Healthcare - South West Oncology
  • UZ Leuven
  • Clinique et Maternite St Elisabeth Namur
  • AZ Delta
  • CHU Mont-Godinne
  • Hospital de Câncer de Barretos - Fundação Pio XII
  • Clínica de Neoplasias Litoral Ltda.
  • HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer
  • Hospital São Lucas da PUCRS
  • COI - Clínicas Oncológicas Integradas
  • A. C. Camargo Cancer Center - Fundação Antônio Prudente
  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  • BC Cancer Agency Center for the Southern Interior
  • Peking University Cancer Hospital
  • Jilin Cancer Hospital - Oncology
  • Hangzhou First People's Hospital
  • Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
  • Centre Hospitalier de la Côte Basque - Service de Pneumologie
  • Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire
  • Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris - Service d'Oncologie Médicale
  • CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie
  • Asklepios Klinik Harburg - Medizinische Abteilung I
  • Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie
  • Nippon Medical School Hospital - Dept of Respiratory Medicine
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Dept of Respiratory Medicine
  • Saitama Medical University International Medical Center - Dept of Respiratory Medicine
  • National Cancer Center Hospital East - Dept of Respiratory Medicine
  • Kobe City Hospital Organization Kobe City Medical Center General Hospital - Dept of Respiratory Medicine
  • Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
  • Kurume University Hospital - Dept of Lung Cancer Center
  • Aichi Cancer Center Hospital - Dept of Respiratory Medicine
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Kindai University Hospital (13859)
  • Shizuoka Cancer Center
  • Kanagawa Cancer Center - Dept of Respiratory Medicine
  • Keimyung University Dongsan Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Korea University Anam Hospital
  • Severance Hospital, Yonsei University
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Jeroen Bosch Ziekenhuis
  • Meander Medisch Centrum - Dep of Pulmonology
  • Amphia Ziekenhuis - PARENT - Parent
  • Martini ziekenhuis
  • Ziekenhuis St. Jansdal
  • St. Antonius Ziekenhuis - Dept Pulmonology - Nieuwegein
  • St. Elisabeth Ziekenhuis - Parent
  • ISALA Klinieken Locatie Sophia
  • 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
  • Clinica Universidad de Navarra (MAD) - Oncology Service
  • Hospital Universitario 12 de Octubre - Servicio de Oncologia
  • Hospital Universitario Clinico San Carlos - Servicio de Oncologia
  • Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Regional Universitario de Malaga
  • Clinica Universidad de Navarra
  • Complejo Hospitalario Universitario de Santiago - Servicio de Oncologia Medica
  • Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio - Servicio de Oncologia
  • Hospital Universitario Virgen Macarena - Servicio de Oncologia
  • Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
  • Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
  • Hospital Alvaro Cunqueiro - Servicio de Oncologia
  • Taichung Veterans General Hospital
  • Chi Mei Medical Center, Liou Ying
  • National Taiwan University Hospital
  • Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: cCRT plus M7824 followed by M7824

Arm 2: cCRT plus placebo followed by durvalumab

Arm Description

Participants will receive cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.

Participants will receive cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with placebo matched to M7824 followed by durvalumab.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Investigator

Secondary Outcome Measures

Occurrence of Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs
Overall Survival
Objective response according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Duration of Response Assessed by Investigator
Pharmacokinetics Profile of M7824 in Terms of Concentration Immediately at End of Infusion (Ceoi) and Concentration Immediately Before Next Dosing (Ctrough)
Immunogenicity of M7824 as Measured by Antidrug Antibody (ADA) Assays

Full Information

First Posted
February 12, 2019
Last Updated
March 2, 2023
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03840902
Brief Title
M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
Official Title
A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Based on recommendations by an external IDMC, Sponsor decided to discontinue this clinical study due to a low likelihood of achieving superiority in the efficacy endpoints versus standard of care.
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)

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 main purpose of this study is to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

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
Non-small Cell Lung Cancer, Bintrafusp alfa (proposed INN), M7824, Durvalumab, Stage III, INTR@PID LUNG 005

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: cCRT plus M7824 followed by M7824
Arm Type
Experimental
Arm Description
Participants will receive cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.
Arm Title
Arm 2: cCRT plus placebo followed by durvalumab
Arm Type
Active Comparator
Arm Description
Participants will receive cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with placebo matched to M7824 followed by durvalumab.
Intervention Type
Drug
Intervention Name(s)
M7824
Intervention Description
Participants will receive intravenous infusion of 1200 milligram (mg) M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
Participants will receive intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Participants will receive etoposide 50 mg/m^2 intravenously over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Participants will receive pemetrexed at a dose of 500 mg/m^2 intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Participants will receive carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Participants will receive paclitaxel intravenously at a dose of 45 mg/m^2 over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
In combination with etoposide, participants will receive cisplatin 50 mg/m^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants will receive cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT.
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy (IMRT)
Intervention Description
Participants will receive IMRT 5 fractions per week for about 6 weeks (Total 60 gray [Gy]).
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Investigator
Time Frame
Time from randomization to final assessment at 3 years and 6 months
Secondary Outcome Measure Information:
Title
Occurrence of Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs
Time Frame
Time from randomization to final assessment at 3 years and 6 months
Title
Overall Survival
Time Frame
Time from randomization to final assessment at 3 years and 6 months
Title
Objective response according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time Frame
Time from randomization to final assessment at 3 years and 6 months
Title
Duration of Response Assessed by Investigator
Time Frame
Time from randomization to final assessment at 3 years and 6 months
Title
Pharmacokinetics Profile of M7824 in Terms of Concentration Immediately at End of Infusion (Ceoi) and Concentration Immediately Before Next Dosing (Ctrough)
Time Frame
Time from randomization to final assessment at 17 months
Title
Immunogenicity of M7824 as Measured by Antidrug Antibody (ADA) Assays
Time Frame
Time from randomization to final assessment at 17 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible. Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of predicted normal volume measured within 3 weeks prior to randomization. Adequate hematological, hepatic and renal function as defined in the protocol Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies Exclusion Criteria: Participants with Mixed small cell with non-small cell lung cancer histology Recent major surgery within 4 weeks prior to entry into the study Significant acute or chronic infections including human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and active tuberculosis Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug targeting T-cell coregulatory proteins
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
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCLA Hematology Oncology - Main Site - 2020 Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Health - Memorial Hospital - Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Hematology Oncology Associates
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Lynn Cancer Institute Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Holy Cross Hospital - Michael and Dianne Bienes CCC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center - University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
American Health Network of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Franciscan St. Francis Health Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Baptist Health Lexington Oncology Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Maryland - DUPLICATE/Pediatric Surgery
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Hematology Oncology Center of Nyack Hospital
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
FirstHealth of the Carolinas, Inc.
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
The James Cancer Hospital and Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sanatorio Allende
City
Cordoba
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Inv. Clinica CER
City
San Juan
Country
Argentina
Facility Name
Bendigo Hospital
City
Bendigo
Country
Australia
Facility Name
The Townsville Hospital
City
Douglas
Country
Australia
Facility Name
Calvary Central Districts Hospital
City
Elizabeth Vale
Country
Australia
Facility Name
St Vincent's Hospital Melbourne - PARENT
City
Fitzroy
Country
Australia
Facility Name
University Hospital Geelong - PARENT
City
Geelong
Country
Australia
Facility Name
Austin Health
City
Heidelberg Heights
Country
Australia
Facility Name
Centro de Investigacion Pergamino SA
City
Pergamino
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
Country
Australia
Facility Name
South West Healthcare - South West Oncology
City
Warrnambool
Country
Australia
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Clinique et Maternite St Elisabeth Namur
City
Namur
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Facility Name
CHU Mont-Godinne
City
Yvoir
Country
Belgium
Facility Name
Hospital de Câncer de Barretos - Fundação Pio XII
City
Barretos
Country
Brazil
Facility Name
Clínica de Neoplasias Litoral Ltda.
City
Itajaí
Country
Brazil
Facility Name
HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer
City
Porto Alegre
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
Country
Brazil
Facility Name
COI - Clínicas Oncológicas Integradas
City
Rio de Janeiro
Country
Brazil
Facility Name
A. C. Camargo Cancer Center - Fundação Antônio Prudente
City
São Paulo
Country
Brazil
Facility Name
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
City
São Paulo
Country
Brazil
Facility Name
BC Cancer Agency Center for the Southern Interior
City
Kelowna
Country
Canada
Facility Name
Peking University Cancer Hospital
City
Beijing
Country
China
Facility Name
Jilin Cancer Hospital - Oncology
City
Changchun
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
Country
China
Facility Name
Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
City
Olomouc
Country
Czechia
Facility Name
Centre Hospitalier de la Côte Basque - Service de Pneumologie
City
Bayonne
Country
France
Facility Name
Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire
City
Marseille cedex 20
Country
France
Facility Name
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris - Service d'Oncologie Médicale
City
Paris Cedex 05
Country
France
Facility Name
CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie
City
Saint Herblain
Country
France
Facility Name
Asklepios Klinik Harburg - Medizinische Abteilung I
City
Hamburg
Country
Germany
Facility Name
Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie
City
Oldenburg
Country
Germany
Facility Name
Nippon Medical School Hospital - Dept of Respiratory Medicine
City
Bunkyo-ku
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Dept of Respiratory Medicine
City
Bunkyo-ku
Country
Japan
Facility Name
Saitama Medical University International Medical Center - Dept of Respiratory Medicine
City
Hidaka-shi
Country
Japan
Facility Name
National Cancer Center Hospital East - Dept of Respiratory Medicine
City
Kashiwa-shi
Country
Japan
Facility Name
Kobe City Hospital Organization Kobe City Medical Center General Hospital - Dept of Respiratory Medicine
City
Kobe-shi
Country
Japan
Facility Name
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
City
Koto-ku
Country
Japan
Facility Name
Kurume University Hospital - Dept of Lung Cancer Center
City
Kurume-shi
Country
Japan
Facility Name
Aichi Cancer Center Hospital - Dept of Respiratory Medicine
City
Nagoya-shi
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka-shi
Country
Japan
Facility Name
Kindai University Hospital (13859)
City
Osakasayama-shi
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
Country
Japan
Facility Name
Kanagawa Cancer Center - Dept of Respiratory Medicine
City
Yokohama-shi
Country
Japan
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Jeroen Bosch Ziekenhuis
City
's Hertogenbosch
Country
Netherlands
Facility Name
Meander Medisch Centrum - Dep of Pulmonology
City
Amersfoort
Country
Netherlands
Facility Name
Amphia Ziekenhuis - PARENT - Parent
City
Breda
Country
Netherlands
Facility Name
Martini ziekenhuis
City
Groningen
Country
Netherlands
Facility Name
Ziekenhuis St. Jansdal
City
Harderwijk
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis - Dept Pulmonology - Nieuwegein
City
Nieuwegein
Country
Netherlands
Facility Name
St. Elisabeth Ziekenhuis - Parent
City
Tilburg
Country
Netherlands
Facility Name
ISALA Klinieken Locatie Sophia
City
Zwolle
Country
Netherlands
Facility Name
Hospital del Mar - Servicio de Oncologia
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron - Dept of Oncology
City
Barcelona
Country
Spain
Facility Name
ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
Clinica Universidad de Navarra (MAD) - Oncology Service
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre - Servicio de Oncologia
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos - Servicio de Oncologia
City
Madrid
Country
Spain
Facility Name
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago - Servicio de Oncologia Medica
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena - Servicio de Oncologia
City
Sevilla
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
City
Valencia
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
City
Valencia
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro - Servicio de Oncologia
City
Vigo
Country
Spain
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
Chi Mei Medical Center, Liou Ying
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan

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_0005
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 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

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