Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

168

Study ID:

NCT03840902

Recruitment Status:

Active, not recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 21 Locations for this study

See Locations Near You

University of California Irvine Medical Center
Orange California, 92868, United States
UCLA Hematology Oncology - Main Site - 2020 Santa Monica
Santa Monica California, 90404, United States
University of Colorado Health - Memorial Hospital - Memorial Hospital
Colorado Springs Colorado, 80909, United States
Hematology Oncology Associates
Fort Collins Colorado, 80528, United States
Lynn Cancer Institute Center
Boca Raton Florida, 33486, United States
Holy Cross Hospital - Michael and Dianne Bienes CCC
Fort Lauderdale Florida, 33308, United States
Sylvester Comprehensive Cancer Center - University of Miami Health System
Miami Florida, 33136, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
American Health Network of Indiana, LLC
Indianapolis Indiana, 46202, United States
Franciscan St. Francis Health Cancer Center
Indianapolis Indiana, 46237, United States
Baptist Health Lexington Oncology Associates
Lexington Kentucky, 40503, United States
University of Maryland - DUPLICATE/Pediatric Surgery
Baltimore Maryland, 21201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Mayo Clinic
Rochester Minnesota, 55902, United States
Columbia University Medical Center
New York New York, 10032, United States
Hematology Oncology Center of Nyack Hospital
Nyack New York, 10960, United States
FirstHealth of the Carolinas, Inc.
Pinehurst North Carolina, 28374, United States
The James Cancer Hospital and Solove Research Institute
Columbus Ohio, 43210, United States
UPMC Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology
Houston Texas, 77030, United States
Sanatorio Allende
Cordoba , , Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER
San Juan , , Argentina
Bendigo Hospital
Bendigo , , Australia
The Townsville Hospital
Douglas , , Australia
Calvary Central Districts Hospital
Elizabeth Vale , , Australia
St Vincent's Hospital Melbourne - PARENT
Fitzroy , , Australia
University Hospital Geelong - PARENT
Geelong , , Australia
Austin Health
Heidelberg Heights , , Australia
Centro de Investigacion Pergamino SA
Pergamino , , Australia
Prince of Wales Hospital
Randwick , , Australia
Sunshine Hospital
St Albans , , Australia
Royal North Shore Hospital
St Leonards , , Australia
South West Healthcare - South West Oncology
Warrnambool , , Australia
UZ Leuven
Leuven , , Belgium
Clinique et Maternite St Elisabeth Namur
Namur , , Belgium
AZ Delta
Roeselare , , Belgium
CHU Mont-Godinne
Yvoir , , Belgium
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos , , Brazil
Clínica de Neoplasias Litoral Ltda.
Itajaí , , Brazil
HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer
Porto Alegre , , Brazil
Hospital São Lucas da PUCRS
Porto Alegre , , Brazil
COI - Clínicas Oncológicas Integradas
Rio de Janeiro , , Brazil
A. C. Camargo Cancer Center - Fundação Antônio Prudente
São Paulo , , Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo , , Brazil
BC Cancer Agency Center for the Southern Interior
Kelowna , , Canada
Peking University Cancer Hospital
Beijing , , China
Jilin Cancer Hospital - Oncology
Changchun , , China
Hangzhou First People's Hospital
Hangzhou , , China
Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
Olomouc , , Czechia
Centre Hospitalier de la Côte Basque - Service de Pneumologie
Bayonne , , France
Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire
Marseille cedex 20 , , France
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris - Service d'Oncologie Médicale
Paris Cedex 05 , , France
CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie
Saint Herblain , , France
Asklepios Klinik Harburg - Medizinische Abteilung I
Hamburg , , Germany
Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie
Oldenburg , , Germany
Nippon Medical School Hospital - Dept of Respiratory Medicine
Bunkyo-ku , , Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Dept of Respiratory Medicine
Bunkyo-ku , , Japan
Saitama Medical University International Medical Center - Dept of Respiratory Medicine
Hidaka-shi , , Japan
National Cancer Center Hospital East - Dept of Respiratory Medicine
Kashiwa-shi , , Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital - Dept of Respiratory Medicine
Kobe-shi , , Japan
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
Koto-ku , , Japan
Kurume University Hospital - Dept of Lung Cancer Center
Kurume-shi , , Japan
Aichi Cancer Center Hospital - Dept of Respiratory Medicine
Nagoya-shi , , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka-shi , , Japan
Kindai University Hospital (13859)
Osakasayama-shi , , Japan
Shizuoka Cancer Center
Sunto-gun , , Japan
Kanagawa Cancer Center - Dept of Respiratory Medicine
Yokohama-shi , , Japan
Keimyung University Dongsan Hospital
Daegu , , Korea, Republic of
Seoul National University Bundang Hospital
Seongnam , , Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University
Seoul , , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
Jeroen Bosch Ziekenhuis
's Hertogenbosch , , Netherlands
Meander Medisch Centrum - Dep of Pulmonology
Amersfoort , , Netherlands
Amphia Ziekenhuis - PARENT - Parent
Breda , , Netherlands
Martini ziekenhuis
Groningen , , Netherlands
Ziekenhuis St. Jansdal
Harderwijk , , Netherlands
St. Antonius Ziekenhuis - Dept Pulmonology - Nieuwegein
Nieuwegein , , Netherlands
St. Elisabeth Ziekenhuis - Parent
Tilburg , , Netherlands
ISALA Klinieken Locatie Sophia
Zwolle , , Netherlands
Hospital del Mar - Servicio de Oncologia
Barcelona , , Spain
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica
Barcelona , , Spain
Hospital Universitari Vall d'Hebron - Dept of Oncology
Barcelona , , Spain
ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
L'Hospitalet de Llobregat , , Spain
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid , , Spain
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid , , Spain
Hospital Universitario Clinico San Carlos - Servicio de Oncologia
Madrid , , Spain
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
Madrid , , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , , Spain
Hospital Regional Universitario de Malaga
Málaga , , Spain
Clinica Universidad de Navarra
Pamplona , , Spain
Complejo Hospitalario Universitario de Santiago - Servicio de Oncologia Medica
Santiago de Compostela , , Spain
Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia
Sevilla , , Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
Sevilla , , Spain
Hospital Universitario Virgen Macarena - Servicio de Oncologia
Sevilla , , Spain
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Valencia , , Spain
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
Valencia , , Spain
Hospital Alvaro Cunqueiro - Servicio de Oncologia
Vigo , , Spain
Taichung Veterans General Hospital
Taichung , , Taiwan
Chi Mei Medical Center, Liou Ying
Tainan , , Taiwan
National Taiwan University Hospital
Taipei , , Taiwan
Tri-Service General Hospital
Taipei , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

168

Study ID:

NCT03840902

Recruitment Status:

Active, not recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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