Lung Cancer Clinical 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)

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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

304

Study ID:

NCT03631706

Recruitment Status:

Active, not recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 115 Locations for this study

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Oncology Specialties, PC; Clearview Cancer Institute
Huntsville Alabama, 35805, United States
Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic
Los Angeles California, 90048, United States
UC Irvine Medical Center
Orange California, 92868, United States
Kaiser Permanente - Harbor City
San Diego California, 92120, United States
Sansum Clinic - Santa Barbara
Santa Barbara California, 93105, United States
Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada
Colorado Springs Colorado, 80907, United States
Eastern Connecticut Hematology/Oncology Assoc.
Norwich Connecticut, 06360, United States
Cancer Specialists, LLC - Department of Clinical Research
Jacksonville Florida, 32256, United States
Woodlands Medical Specialists
Pensacola Florida, 32503, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
Decatur Memorial Hospital - Clinical Research
Decatur Illinois, 62526, United States
Baptist Health Lexington Oncology Associates
Lexington Kentucky, 40503, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Henry Ford Medical Center
Detroit Michigan, 48202, United States
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account
Kansas City Missouri, 64132, United States
Southeast Nebraska Cancer Center
Lincoln Nebraska, 68510, United States
The Valley Hospital - Luckow Pavilion
Paramus New Jersey, 07652, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
UPMC Cancer Center
Pittsburgh Pennsylvania, 15232, United States
SCRI - Tennessee Oncology
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Texas Oncology - Bedford
Bedford Texas, 76022, United States
Texas Oncology, P.A. - Sugarland
Sugar Land Texas, 77479, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Centro de Oncologia e Investigacion Buenos Aires
Berazategui , B1880, Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires , C1426, Argentina
Sanatorio Allende
Cordoba , X5000, Argentina
Instituto Medico Rio Cuarto
Rio Cuarto , 5800, Argentina
Instituto de Oncología de Rosario
Rosario , S2000, Argentina
Centro Medico San Roque S.R.L.
San Miguel de Tucuman , 4000, Argentina
Universitair Ziekenhuis Brussel - Geriatrie
Bruxelles , 1090, Belgium
Jessa Ziekenhuis Hospital
Hasselt , 3500, Belgium
UZ Leuven
Pellenberg , 3212, Belgium
CHU Mont-Godinne
Yvoir , 5530, Belgium
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos , 14784, Brazil
CRIO - Centro Regional Integrado de Oncologia
Fortaleza , 60336, Brazil
Hospital São Lucas da PUCRS
Porto Alegre , 90610, Brazil
INCA - Instituto Nacional de Câncer
Rio de Janeiro , 20230, Brazil
NOB - Núcleo de Oncologia da Bahia
Salvador , 40170, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo Andre , 09060, Brazil
Saint John Regional Hospital
St. John New Brunswick, E2L 4, Canada
Tom Baker Cancer Centre
Alberta , T2N 4, Canada
Stronach Regional Cancer Centre - at Southlake
Ontario , L3Y 2, Canada
Peking University Cancer Hospital
Beijing , 10014, China
Guangdong General Hospital
Guangzhou , 51008, China
Shanghai Cancer Hospital, Fudan University
Shanghai , 20003, China
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha
Pessac Gironde, 33604, France
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
Creteil Cedex Val De Marne, 94010, France
Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire
Bouches-du-Rhône , 13915, France
Centre Léon Bérard
Lyon Cedex 08 , 69373, France
CHU Rennes - Hopital Pontchaillou - service de pneumologie
Rennes cedex 09 , 35033, France
ICO - Site René Gauducheau
Saint Herblain , 44805, France
CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique
Toulouse , 31059, France
Vivantes Klinikum Am Urban - Haematologie und Onkologie
Berlin , 10967, Germany
Asklepios Fachkliniken Muenchen-Gauting - Abteilung Internistische Onkologie
Gauting , 82131, Germany
LungenClinic Grosshansdorf
Grosshansdorf , 22927, Germany
Medizinische Hochschule Hannover - Pneumologie
Hannover , 30625, Germany
Universitaetsklinikum Schleswig- Holstein Campus Luebeck
Luebeck , 23538, Germany
Universitaetsklinikum Regensburg - Klinik und Poliklinik fuer Innere Medizin II
Regensburg , , Germany
251 General Air Force Hospital
Athens , 11525, Greece
General Hospital of Athens of Chest Disease "SOTIRIA"
Athens , 11527, Greece
University General Hospital of Heraklion "PAGNI"
Heraklion , 71110, Greece
General Hospital Papageorgiou-2nd Department of Dermatalogy
Thessaloniki , 56429, Greece
Princess Margaret Hospital
Hong Kong , 00000, Hong Kong
The University of Hong Kong
Hong Kong , , Hong Kong
The Chinese University of Hong Kong - Emergency Medicine
Shatin , 00000, Hong Kong
Azienda Ospedaliera San Giuseppe Moscati - U.O Oncologia Medica
Avellino , 83100, Italy
IRCCS Centro di Riferimento Oncologico - Oncologia Medica A
Aviano , 33081, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Oncologia Medica
Bologna , 40138, Italy
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico - Unità Operativa di Oncologia
Catania , 95123, Italy
Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario - Centro Oncologico
Catanzaro , 88100, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - Medicina Oncologica I
Milano , 20133, Italy
Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia
Napoli , 80131, Italy
NHO Hokkaido Cancer Center - Dept of Respiratory Medicine
Sapporo-shi Hokkaido, 003-0, Japan
National Cancer Center Hospital - Dept of Respiratory Medicine
Chuo-ku , 104-0, Japan
Saitama Medical University International Medical Center - Dept of Respiratory Medicine
Hidaka-shi , , Japan
Saitama Cancer Center
Kitaadachigun , 362-0, Japan
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine
Koto-ku , 135-8, Japan
Kurume University Hospital
Kurume-shi , 830-0, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka-shi , 541-8, Japan
Kindai University Hospital
Osakasayama-sh , 589-8, Japan
Chungbuk National University Hospital
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
Universitair Medisch Centrum Groningen (UMCG) - Parent
Groningen , 9713 , Netherlands
Maastricht University Medical Center - Dept of Medical Oncology
Maastricht , 6202 , Netherlands
Erasmus Medisch Centrum
Rotterdam , 3015 , Netherlands
St. Elisabeth Ziekenhuis - Parent
Tilburg , 5022 , Netherlands
Hospital del Mar - Servicio de Oncologia
Barcelona , 08003, Spain
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica
Barcelona , 08028, Spain
Hospital Universitari Vall d'Hebron - Dept of Oncology
Barcelona , 08035, Spain
ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
L'Hospitalet de Llobregat , 08908, Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid , 28041, Spain
Hospital Regional Universitario de Malaga
Málaga , 29010, Spain
Hospital Universitario Virgen Macarena - Servicio de Oncologia
Sevilla , 41009, Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
Sevilla , 41013, Spain
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
Valencia , 46026, Spain
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Tri-Service General Hospital
Taipei , 11490, Taiwan
Adana Numune Training and Research Hospital - Cardiology Department
Adana , 01370, Turkey
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Oncology Department
Ankara , 06105, Turkey
Trakya University Medical Faculty - Medical Oncology
Edirne , 22030, Turkey
Kocaeli University Research and Application Hospital
Kocaeli , 41380, Turkey
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU - Ch of Oncology and MR
Dnipro , 49102, Ukraine
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU - Chair of Oncology
Ivano-Frankivsk , 76018, Ukraine
Communal Non-profit Enterprise Regional Center of Oncology - Parent
Kharkiv , 61070, Ukraine
Medical and Preventive Treatment Institution Volyn Regional Oncological Dispensary - Dept of Oncochemotherapy
Lutsk , 43018, Ukraine
CCCH City Oncological Center SHEI Uzhgorod NU - Ch of R&O of Faculty of PGE&PUT
Uzhgorod , 88000, Ukraine
Medical center "Oncolife"
Zaporizhzhia , 69059, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

304

Study ID:

NCT03631706

Recruitment Status:

Active, not recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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