M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT03840902
Last Updated: 2024-01-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
153 participants
INTERVENTIONAL
2019-04-16
2023-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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cCRT plus M7824 followed by M7824
Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.
M7824
Participants received 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.
Etoposide
Participants received 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.
Pemetrexed
Participants received 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.
Carboplatin
Participants received 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.
Paclitaxel
Participants received 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.
Cisplatin
In combination with etoposide, participants received cisplatin 50 mg/m\^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants received cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT.
Intensity Modulated Radiation Therapy (IMRT)
Participants received IMRT 5 fractions per week for about 6 weeks (Total 60 gray \[Gy\]).
cCRT plus placebo followed by durvalumab
Participants received 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.
Placebo
Participants received intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
Durvalumab
Participants received 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.
Etoposide
Participants received 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.
Pemetrexed
Participants received 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.
Carboplatin
Participants received 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.
Paclitaxel
Participants received 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.
Cisplatin
In combination with etoposide, participants received cisplatin 50 mg/m\^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants received cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT.
Intensity Modulated Radiation Therapy (IMRT)
Participants received IMRT 5 fractions per week for about 6 weeks (Total 60 gray \[Gy\]).
Interventions
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M7824
Participants received 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.
Placebo
Participants received intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
Durvalumab
Participants received 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.
Etoposide
Participants received 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.
Pemetrexed
Participants received 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.
Carboplatin
Participants received 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.
Paclitaxel
Participants received 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.
Cisplatin
In combination with etoposide, participants received cisplatin 50 mg/m\^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants received cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT.
Intensity Modulated Radiation Therapy (IMRT)
Participants received IMRT 5 fractions per week for about 6 weeks (Total 60 gray \[Gy\]).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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University of California Irvine Medical Center
Orange, California, United States
UCLA Hematology Oncology - Main Site - 2020 Santa Monica
Santa Monica, California, United States
University of Colorado Health - Memorial Hospital - Memorial Hospital
Colorado Springs, Colorado, United States
Hematology Oncology Associates
Fort Collins, Colorado, United States
Lynn Cancer Institute Center
Boca Raton, Florida, United States
Holy Cross Hospital - Michael and Dianne Bienes CCC
Fort Lauderdale, Florida, United States
Sylvester Comprehensive Cancer Center - University of Miami Health System
Miami, Florida, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
American Health Network of Indiana, LLC
Indianapolis, Indiana, United States
Franciscan St. Francis Health Cancer Center
Indianapolis, Indiana, United States
Baptist Health Lexington Oncology Associates
Lexington, Kentucky, United States
University of Maryland - DUPLICATE/Pediatric Surgery
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Hematology Oncology Center of Nyack Hospital
Nyack, New York, United States
FirstHealth of the Carolinas, Inc.
Pinehurst, North Carolina, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology
Houston, Texas, United States
Sanatorio Allende
Córdoba, , 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, , France
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris - Service d'Oncologie Médicale
Paris, , 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
Bunkyō City, , Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Dept of Respiratory Medicine
Bunkyō City, , 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, , Japan
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
Kōtoku, , Japan
Kurume University Hospital - Dept of Lung Cancer Center
Kurume-shi, , Japan
Aichi Cancer Center Hospital - Dept of Respiratory Medicine
Nagoya, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, , Japan
Kindai University Hospital (13859)
Osakasayama-shi, , Japan
Shizuoka Cancer Center
Sunto-gun, , Japan
Kanagawa Cancer Center - Dept of Respiratory Medicine
Yokohama, , Japan
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
Keimyung University Dongsan Hospital
Daegu, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
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
Seville, , Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
Seville, , Spain
Hospital Universitario Virgen Macarena - Servicio de Oncologia
Seville, , 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 City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Countries
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References
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Huang Y, Zhao JJ, Soon YY, Wong A, Aminkeng F, Ang Y, Asokumaran Y, Low JL, Lee M, Choo JRE, Chan G, Kee A, Tay SH, Goh BC, Soo RA. Real-world experience of consolidation durvalumab after concurrent chemoradiotherapy in stage III non-small cell lung cancer. Thorac Cancer. 2022 Nov;13(22):3152-3161. doi: 10.1111/1759-7714.14667. Epub 2022 Sep 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2018-003265-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS200647_0005
Identifier Type: -
Identifier Source: org_study_id
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