Clinical trial NCT03840902: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Bintrafusp alfa (proposed INN)
M7824
Durvalumab
Stage III
INTR@PID LUNG 005
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2019-02-15
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study was 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.


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

Primary outcomes:
measure: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
timeFrame: Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events
timeFrame: Time from randomization up to data cut off (assessed up to 27 months)
measure: Overall Survival (OS)
timeFrame: Time from randomization to the date of death due to any cause, assessed up to 27 months
measure: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
timeFrame: Time from randomization up to data cut off (assessed up to 27 months)
measure: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
timeFrame: Time from first documentation of objective response to the date of first documentation of PD or death due to any cause, assessed approximately up to 27 months
measure: Immediate Observed Serum Concentration at End of Infusion (Ceoi) of M7824
timeFrame: Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343
measure: Serum Concentration Immediately Before Next Dosing (Ctrough) of M7824
timeFrame: Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343
measure: Number of Participants With Positive Antidrug Antibodies (ADA)
timeFrame: Time from randomization up to data cut off (assessed up to 27 months)
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology - Main Site - 2020 Santa Monica
state: California
city: Colorado Springs
country: United States
facility: University of Colorado Health - Memorial Hospital - Memorial Hospital
state: Colorado
city: Fort Collins
country: United States
facility: Hematology Oncology Associates
state: Colorado
city: Boca Raton
country: United States
facility: Lynn Cancer Institute Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital - Michael and Dianne Bienes CCC
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center - University of Miami Health System
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health Cancer Center
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington Oncology Associates
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland - DUPLICATE/Pediatric Surgery
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Center of Nyack Hospital
state: New York
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas, Inc.
state: North Carolina
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology
state: Texas
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Inv. Clinica CER
city: Bendigo
country: Australia
facility: Bendigo Hospital
city: Douglas
country: Australia
facility: The Townsville Hospital
city: Elizabeth Vale
country: Australia
facility: Calvary Central Districts Hospital
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne - PARENT
city: Geelong
country: Australia
facility: University Hospital Geelong - PARENT
city: Heidelberg Heights
country: Australia
facility: Austin Health
city: Pergamino
country: Australia
facility: Centro de Investigacion Pergamino SA
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: St Albans
country: Australia
facility: Sunshine Hospital
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
city: Warrnambool
country: Australia
facility: South West Healthcare - South West Oncology
city: Leuven
country: Belgium
facility: UZ Leuven
city: Namur
country: Belgium
facility: Clinique et Maternite St Elisabeth Namur
city: Roeselare
country: Belgium
facility: AZ Delta
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
city: Barretos
country: Brazil
facility: Hospital de Câncer de Barretos - Fundação Pio XII
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda.
city: Porto Alegre
country: Brazil
facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
city: Rio de Janeiro
country: Brazil
facility: COI - Clínicas Oncológicas Integradas
city: São Paulo
country: Brazil
facility: A. C. Camargo Cancer Center - Fundação Antônio Prudente
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
city: Kelowna
country: Canada
facility: BC Cancer Agency Center for the Southern Interior
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital - Oncology
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc - Dept of Onkologicka klinika
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque - Service de Pneumologie
city: Marseille cedex 20
country: France
facility: Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire
city: Paris Cedex 05
country: France
facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris - Service d'Oncologie Médicale
city: Saint Herblain
country: France
facility: CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg - Medizinische Abteilung I
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital - Dept of Respiratory Medicine
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Dept of Respiratory Medicine
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center - Dept of Respiratory Medicine
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East - Dept of Respiratory Medicine
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital - Dept of Respiratory Medicine
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
city: Kurume-shi
country: Japan
facility: Kurume University Hospital - Dept of Lung Cancer Center
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital - Dept of Respiratory Medicine
city: Osaka-shi
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital (13859)
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center - Dept of Respiratory Medicine
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum - Dep of Pulmonology
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - PARENT - Parent
city: Groningen
country: Netherlands
facility: Martini ziekenhuis
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis - Dept Pulmonology - Nieuwegein
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis - Parent
city: Zwolle
country: Netherlands
facility: ISALA Klinieken Locatie Sophia
city: Barcelona
country: Spain
facility: Hospital del Mar - Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Dept of Oncology
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra (MAD) - Oncology Service
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos - Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago - Servicio de Oncologia Medica
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro - Servicio de Oncologia
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center, Liou Ying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: