Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631706
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: M7824 Drug: Pembrolizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : June 18, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: M7824 Drug: M7824
Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks starting from Day 1 up to disease progression.

Active Comparator: Pembrolizumab Drug: Pembrolizumab
Participants will receive an intravenous infusion of 200 mg Pembrolizumab once every 3 weeks starting from Day 1 up to disease progression.




Primary Outcome Measures :
  1. Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [ Time Frame: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months ]
  2. Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [ Time Frame: Time from randomization to planned final assessment, expected at 37 months ]

Secondary Outcome Measures :
  1. Occurrences of Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [ Time Frame: Randomization up to the last safety follow-up visit, expected at approximately 47 months ]
  2. Overall Survival (OS) Time [ Time Frame: Randomization up to 49 months ]
  3. Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator [ Time Frame: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months ]
  4. Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator [ Time Frame: Time from randomization to planned final assessment, expected at 37 months ]
  5. Duration of Response Assessed from Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 Assessed by Independent Review Committee [ Time Frame: Time from CR or PR to planned assessment, expected at 37 months ]
  6. Concentration of M7284 at the end of Infusion (Ceoi) [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months) ]
  7. Concentration of M7284 at the end of the Dosing Interval (C trough) [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months) ]
  8. Immunogenicity as measured by Anti-drug Antibodies Concentration [ Time Frame: Randomization up to safety follow-up visit (28 days post last-dose of study drug administration, assessed up to 47 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 either tumor archival material (less than 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
  • PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1 immunohistochemistry 22C3 pharmDx assay
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631706


Contacts
Layout table for location contacts
Contact: US Medical Information 888-275-7376 service@emdgroup.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Oncology Specialties, PC; Clearview Cancer Institute Recruiting
Huntsville, Alabama, United States, 35805
United States, California
California Cancer Associates for Research & Excellence, Inc Recruiting
Escondido, California, United States, 92025
Principal Investigator: Joseph Pascuzzo, Dr.         
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Principal Investigator: Viola Zhu, Dr.         
Kaiser Permanente - Harbor City Recruiting
San Diego, California, United States, 92120
Contact       han.a.koh@kp.org   
Principal Investigator: Han A Koh         
Sharp Memorial Hospital (6993) Recruiting
San Diego, California, United States, 92123
Contact       kai.zu@sharp.com   
Principal Investigator: Kai Zu         
Sansum Clinic - Santa Barbara Recruiting
Santa Barbara, California, United States, 93105
Contact       mgupta@ridleytreecc.org   
Principal Investigator: Mukul Gupta         
United States, Colorado
Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada Recruiting
Colorado Springs, Colorado, United States, 80907
Contact       michael.monticelli@usoncology.com   
Principal Investigator: Michael A Monticelli         
United States, Connecticut
Eastern Connecticut Hematology/Oncology Assoc. Recruiting
Norwich, Connecticut, United States, 06360
United States, Florida
Cancer Specialists, LLC - Department of Clinical Research Recruiting
Jacksonville, Florida, United States, 32256
Contact       research@csnf.us   
Principal Investigator: Susmitha Vaka         
Woodlands Medical Specialists Recruiting
Pensacola, Florida, United States, 32503
Contact       rami.owera@usoncology.com   
Principal Investigator: Rami Owera         
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact       cbestvina@medicine.bsd.uchicago.edu   
Principal Investigator: Christine Bestvina         
Decatur Memorial Hospital - Clinical Research Recruiting
Decatur, Illinois, United States, 62526
United States, Indiana
St. Francis Cancer Research Foundation - Pharmatech Oncology, Inc. Withdrawn
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Baptist Health Lexington Oncology Associates Recruiting
Lexington, Kentucky, United States, 40503
Contact       firas.badin@bhsi.com   
Principal Investigator: Firas Badin         
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact       john.hamm@nortonhealthcare.org   
Principal Investigator: John T Hamm         
United States, Michigan
Henry Ford Medical Center Recruiting
Detroit, Michigan, United States, 48202
Contact       irybkin1@hfhs.org   
Principal Investigator: Igor Rybkin         
United States, Missouri
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account Recruiting
Kansas City, Missouri, United States, 64132
Contact       joseph.stilwill@hcahealthcare.com   
Principal Investigator: Joseph F Stilwill         
United States, Nebraska
Southeast Nebraska Cancer Center (7331) Recruiting
Lincoln, Nebraska, United States, 68510
United States, New Jersey
The Valley Hospital - Luckow Pavilion Recruiting
Paramus, New Jersey, United States, 07652
United States, New York
Hematology Oncology Center of Nyack Hospital Withdrawn
Nyack, New York, United States, 10960
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact       deborah_mulford@urmc.rochester.edu   
Principal Investigator: Deborah Mulford         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact       stevenj5@ccf.org   
Principal Investigator: James Stevenson         
United States, Pennsylvania
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact       villaruzl@upmc.edu   
Principal Investigator: Liza C Villaruz         
United States, Tennessee
SCRI - Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact       dspigel@tnonc.com   
Principal Investigator: David R Spigel         
Vanderbilt University Medical Center (8813) Recruiting
Nashville, Tennessee, United States, 37232
Contact       wade.iams@vumc.org   
Principal Investigator: Wade Iams         
United States, Texas
Texas Oncology - Bedford Recruiting
Bedford, Texas, United States, 76022
Contact       henrik.illum@usoncology.com   
Principal Investigator: Henrik B Illum         
Texas Oncology, P.A. - Sugarland Recruiting
Sugar Land, Texas, United States, 77479
Contact       Caesar.Tin-U@USOncology.com   
Principal Investigator: Caesar K Tin-U         
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact       timothy.mccarthy@usoncology.com   
Principal Investigator: Timothy McCarthy         
United States, Washington
Providence Regional Cancer Partnership (11212) Recruiting
Everett, Washington, United States, 98201
Contact       akundra@everettclinic.com   
Principal Investigator: Ajay Kundra         
Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson Recruiting
Wenatchee, Washington, United States, 98801
Argentina
Centro de Oncologia e Investigacion Buenos Aires (12526) Recruiting
Berazategui, Argentina, B1880BBF
Contact       msvarela@fibertel.com.ar   
Principal Investigator: Mirta Susana Varela         
Instituto Medico Especializado Alexander Fleming Recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1426ANZ
Contact       im-mclaudio@alexanderfleming.org   
Principal Investigator: Claudio Martin         
Sanatorio Allende Recruiting
Cordoba, Argentina, X5000JHQ
Contact       gjarchum@sanatorioallende.com   
Principal Investigator: Gustavo Jarchum         
Instituto Medico Rio Cuarto Recruiting
Rio Cuarto, Argentina, 5800
Contact       ignacio.magri@gmail.com   
Principal Investigator: Ignacio Magri         
Instituto de Oncología de Rosario (12589) Recruiting
Rosario, Argentina, S2000KZE
Contact       luisfein@institutodeoncologia.com   
Principal Investigator: Luis Enrique Fein         
Centro Medico San Roque S.R.L. Recruiting
San Miguel de Tucuman, Argentina, 4000
Contact       josezarba@gmail.com   
Principal Investigator: Juan Jose Zarba         
Belgium
Universitair Ziekenhuis Brussel - Geriatrie Recruiting
Bruxelles, Belgium, 1090
Contact       lore.decoster@uzbrussel.be   
Principal Investigator: Lore Decoster         
Jessa Ziekenhuis Hospital Recruiting
Hasselt, Belgium, 3500
Contact       kristof.cuppens@jessazh.be   
Principal Investigator: Kristof Cuppens         
UZ Leuven Recruiting
Pellenberg, Belgium, 3212
Principal Investigator: Johan Vansteenkiste, Prof.         
CHU Mont-Godinne Recruiting
Yvoir, Belgium, 5530
Principal Investigator: Sebahat Ocak, Prof.         
Brazil
Hospital de Câncer de Barretos - Fundação Pio XII Recruiting
Barretos, Brazil, 14784-400
Contact       pedrodemarchi@yahoo.com.br   
Principal Investigator: Pedro Rafael Martins De Marchi         
CRIO - Centro Regional Integrado de Oncologia Recruiting
Fortaleza, Brazil, 60336-045
Contact       cronemberger.eduardo@gmail.com   
Principal Investigator: Eduardo Henrique Cronemberger Costa e Silva         
Hospital São Lucas da PUCRS (13874) Recruiting
Porto Alegre, Brazil, 90610-000
Contact       chbe@via-rs.net   
Principal Investigator: Carlos Henrique Escosteguy Barrios         
INCA - Instituto Nacional de Câncer Recruiting
Rio de Janeiro, Brazil, 20230-230
Contact       luiz.lima@inca.gov.br   
Principal Investigator: Luiz Henrique de Lima Araújo         
NOB - Núcleo de Oncologia da Bahia Recruiting
Salvador, Brazil, 40170-110
Contact       marilia.cardoso@nob-ba.com.br   
Principal Investigator: Eldsamira da Silva Mascarenhas Schettini Sobrinho         
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia - Faculdade de Medicina do ABC Recruiting
Santo Andre, Brazil, 09060-650
Contact       claudia.sette@cepho.org.br   
Principal Investigator: Claudia Vaz de Melo Sette         
Canada, New Brunswick
Saint John Regional Hospital (11314) Recruiting
St. John, New Brunswick, Canada, E2L 4L2
Contact       anthony.reiman@horizonnb.ca   
Principal Investigator: Anthony J Reiman         
China
Peking University Cancer Hospital Recruiting
Beijing, China, 100142
Contact       ohjerry@163.com   
Principal Investigator: Jun Zhao         
Peking University Cancer Hospital Recruiting
Beijing, China, 100142
Contact       fangjian5555@163.com   
Principal Investigator: Jian Fang         
Guangdong General Hospital Recruiting
Guangzhou, China, 510080
Contact       gzzhouqing@qq.com   
Principal Investigator: Qing Zhou         
Shanghai Cancer Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact       changjianhuagcp@163.com   
Principal Investigator: Jianhua Chang         
France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha Recruiting
Pessac, Gironde, France, 33604
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie Recruiting
Creteil Cedex, Val De Marne, France, 94010
Principal Investigator: Christos Chouaid, Prof.         
Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire Recruiting
Bouches-du-Rhône, France, 13915
Contact       fabrice.barlesi@ap-hm.fr   
Principal Investigator: Fabrice Barlesi         
Centre Léon Bérard (7144) Recruiting
Lyon Cedex 08, France, 69373
Contact       maurice.perol@lyon.unicancer.fr   
Principal Investigator: Maurice Perol         
CHU Rennes - Hopital Pontchaillou - service de pneumologie Recruiting
Rennes cedex 09, France, 35033
Contact       herve.lena@chu-rennes.fr   
Principal Investigator: Hervé Lena         
ICO - Site René Gauducheau (10993) Recruiting
Saint Herblain, France, 44805
Contact       sandrine.hiret@ico.unicancer.fr   
Principal Investigator: Sandrine Hiret         
CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique Recruiting
Toulouse, France, 31059
Contact       mazieres.j@chu-toulouse.fr   
Principal Investigator: Julien Mazieres         
Germany
Vivantes Klinikum Am Urban - Haematologie und Onkologie Recruiting
Berlin, Germany, 10967
Contact       christianw.scholz@vivantes.de   
Principal Investigator: Christian Scholz         
Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie Recruiting
Gauting, Germany, 82131
Contact       n.reinmuth@asklepios.com   
Principal Investigator: Niels Reinmuth         
LungenClinic Großhansdorf Recruiting
Grosshansdorf, Germany, 22927
Contact       dr.martin.reck@web.de   
Principal Investigator: Martin Reck         
Medizinische Hochschule Hannover - Pneumologie Recruiting
Hannover, Germany, 30625
Contact       golpon.heiko@mh-hannover.de   
Principal Investigator: Heiko Golpon         
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck (12723) Recruiting
Luebeck, Germany, 23538
Contact       sabine.bohnet@uksh.de   
Principal Investigator: Sabine Bohnet         
Greece
251 General Air Force Hospital Recruiting
Athens, Greece, 115 25
Contact       nickkent10@yahoo.gr   
Principal Investigator: Nikolaos Kentepozidis         
General Hospital of Athens of Chest Diseases "SOTIRIA" Recruiting
Athens, Greece, 11527
Contact       ksyrigos.trials@gmail.com   
Principal Investigator: KONSTANTINOS SYRIGOS         
University General Hospital of Heraklion "PAGNI" Recruiting
Heraklion, Greece, 71110
Principal Investigator: Dimitrios Mavroudis, Prof.         
General Hospital Papageorgiou - 2nd Department of Dermatology Recruiting
Thessaloniki, Greece, 56429
Principal Investigator: Christos Papandreou, Prof.         
Hong Kong
The University of Hong Kong (13715) Recruiting
Hong Kong, Hong Kong
Contact       jhocm@hku.hk   
Principal Investigator: James Chung Man Ho         
The Chinese University of Hong Kong - Emergency Medicine Recruiting
Shatin, Hong Kong, 00000
Contact       tony@clo.cuhk.edu.hk   
Principal Investigator: Tony Shu Kam Mok         
Italy
Azienda Ospedaliera San Giuseppe Moscati - U.O Oncologia Medica Recruiting
Avellino, Italy, 83100
IRCCS Centro di Riferimento Oncologico - Oncologia Medica A Recruiting
Aviano, Italy, 33081
Contact       abearz@cro.it   
Principal Investigator: Alessandra Bearz         
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Oncologia Medica Recruiting
Bologna, Italy, 40138
Contact       andrea.ardizzoni@aosp.bo.it   
Principal Investigator: Andrea Ardizzoni         
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico - Unità Operativa di Oncologia Recruiting
Catania, Italy, 95123
Contact       hsotoparra@yahoo.it   
Principal Investigator: Hector J Soto Parra         
Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario - Centro Oncologico Recruiting
Catanzaro, Italy, 88100
Principal Investigator: Pier Francesco Tassone, Prof.         
Fondazione IRCCS Istituto Nazionale dei Tumori - Medicina Oncologica I Recruiting
Milano, Italy, 20133
Contact       garassino.studiclinici@istitutotumori.mi.it   
Principal Investigator: Marina C Garassino         
Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia Recruiting
Napoli, Italy, 80131
Contact       FORTUNATO.CIARDIELLO@UNICAMPANIA.IT   
Principal Investigator: Fortunato Ciardiello         
Japan
Aichi Cancer Center Hospital - Dept of Respiratory Medicine Recruiting
Nagoya-shi, Aichi-Ken, Japan, 464-8681
Contact    81527626111    107974@aichi-cc.jp   
Principal Investigator: Toyoaki Hida         
NHO Hokkaido Cancer Center - Dept of Respiratory Medicine Recruiting
Sapporo-shi, Hokkaido, Japan, 003-0804
Principal Investigator: Satoshi Oizumi, Dr.         
National Cancer Center Hospital - Dept of Respiratory Medicine Recruiting
Chuo-ku, Japan, 104-0045
Contact       hhorinou@ncc.go.jp   
Principal Investigator: Hidehito Horinouchi         
Saitama Cancer Center Recruiting
Kitaadachigun, Japan, 362-0806
Principal Investigator: Hiroshi Sakai, Dr.         
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine Recruiting
Koto-ku, Japan, 135-8550
Contact       mnishio@jfcr.or.jp   
Principal Investigator: Makoto Nishio         
Kurume University Hospital (12889) Recruiting
Kurume-shi, Japan, 830-0011
Contact       ishii_hidenobu@med.kurume-u.ac.jp   
Principal Investigator: Hidenobu Ishii         
Osaka Medical Center for Cancer and Cardiovascular Diseases (9308) Recruiting
Osaka-shi, Japan, 541-8567
Contact       torukumagai@ybb.ne.jp   
Principal Investigator: Toru Kumagai         
Kindai University Hospital (13859) Recruiting
Osakasayama-sh, Japan, 589-8511
Contact       hidet31@med.kindai.ac.jp   
Principal Investigator: Hidetoshi Hayashi         
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
Principal Investigator: Ki Hyeong Lee, Prof.         
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Principal Investigator: Jong-Seok Lee, Prof.         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Principal Investigator: Eun Kyung Cho, Prof.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact       gabriel9@snu.ac.kr   
Principal Investigator: Tae Min Kim         
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of, 03722
Contact       cbc1971@yuhs.ac   
Principal Investigator: Byoung Chul Cho         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Principal Investigator: Dae Ho Lee, Dr.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Principal Investigator: Myung-Ju Ahn, Prof.         
Netherlands
Antoni van Leeuwenhoek Ziekenhuis Recruiting
Amsterdam, Netherlands, 1066 CX
Contact       e.smit@nki.nl   
Principal Investigator: Egbert F Smit         
VU Medisch Centrum (12710) Recruiting
Amsterdam, Netherlands, 1081 HV
Contact       s.hashemi@vumc.nl   
Principal Investigator: Sayed Hashemi         
Universitair Medisch Centrum Groningen (UMCG) - Parent Recruiting
Groningen, Netherlands, 9713 GZ
Contact       t.j.n.hiltermann@umcg.nl   
Principal Investigator: Jeroen T Hiltermann         
Maastricht University Medical Center - Dept of Medical Oncology Recruiting
Maastricht, Netherlands, 6202 AZ
Contact       a.dingemans@mumc.nl   
Principal Investigator: Anne-Marie C Dingemans         
Erasmus Medisch Centrum (11321) Recruiting
Rotterdam, Netherlands, 3015 CE
Contact       d.dumoulin@erasmusmc.nl   
Principal Investigator: Daphne D Dumoulin         
St. Elisabeth Ziekenhuis - Parent Recruiting
Tilburg, Netherlands, 5022 GC
Contact       js.kloover@etz.nl   
Principal Investigator: Jeroen S Kloover         
Spain
Hospital del Mar - Servicio de Oncologia Recruiting
Barcelona, Spain, 08003
Contact       earriola@parcdesalutmar.cat   
Principal Investigator: Edurne Arriola Aperribay         
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica Recruiting
Barcelona, Spain, 08028
Contact       sviteri@oncorosell.com   
Principal Investigator: Santiago Viteri Ramirez         
Hospital Universitari Vall d'Hebron - Dept of Oncology Recruiting
Barcelona, Spain, 08035
Contact       efelip@vhio.net   
Principal Investigator: Enriqueta Felip Font         
ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia Recruiting
L'Hospitalet de Llobregat, Spain, 08908
Contact       esnadal@iconcologia.net   
Principal Investigator: Ernest Nadal Alforja         
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica Recruiting
Madrid, Spain, 28007
Contact       antonio.calles@live.com   
Principal Investigator: Antonio Calles Blanco         
Hospital Universitario 12 de Octubre - Servicio de Oncologia Recruiting
Madrid, Spain, 28041
Contact       lpazaresr@seom.org   
Principal Investigator: Luis Paz-Ares Rodriguez         
Hospital Regional Universitario de Malaga (11327) Recruiting
Málaga, Spain, 29010
Contact       manuelcobodols@yahoo.es   
Principal Investigator: Manuel Cobo Dols         
Hospital Universitario Virgen Macarena - Servicio de Oncologia Recruiting
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio - Servicio de Oncologia Recruiting
Sevilla, Spain, 41013
Principal Investigator: Miriam Alonso Garcia, Dr.         
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica Recruiting
Valencia, Spain, 46026
Contact       juan_osc@gva.es   
Principal Investigator: Oscar Jose Juan Vidal         
Taiwan
Taichung Veterans General Hospital (5039) Recruiting
Taichung, Taiwan, 40705
Contact       august@vghtc.gov.tw   
Principal Investigator: Gee-Chen Chang         
National Taiwan University Hospital (5040) Recruiting
Taipei, Taiwan, 100
Contact       chihyang@ntu.edu.tw   
Principal Investigator: Chih-Hsin Yang         
Taipei Veterans General Hospital (8876) Recruiting
Taipei, Taiwan, 11217
Contact       jhchiou@vghtpe.gov.tw   
Principal Investigator: Chao-Hua Chiu         
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 11490
Contact       doc10376@gmail.com   
Principal Investigator: Chen-Liang Tsai         
Turkey
Adana Numune Training and Research Hospital - Cardiology Department Recruiting
Adana, Turkey, 01370
Contact       drtimucincil@gmail.com   
Principal Investigator: Timucin Cil         
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Oncology Department Recruiting
Ankara, Turkey, 06105
Contact       drumutdemirci@gmail.com   
Principal Investigator: Umut Demirci         
Trakya University Medical Faculty - Medical Oncology Recruiting
Edirne, Turkey, 22030
Contact       irfancicin@hotmail.com   
Principal Investigator: Irfan Cicin         
Kocaeli University Research and Application Hospital Recruiting
Kocaeli, Turkey, 41380
Principal Investigator: Devrim Cabuk         
Ukraine
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU - Ch of Oncology and MR Recruiting
Dnipro, Ukraine, 49102
Contact       igor.bondarenko@rdp-ukraine.com   
Principal Investigator: Igor N Bondarenko         
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU - Chair of Oncology Recruiting
Ivano-Frankivsk, Ukraine, 76018
Contact       anna.nivska@gmail.com   
Principal Investigator: Anna Kryzhanivska         
Communal Non-profit Enterprise Regional Center of Oncology - Parent Recruiting
Kharkiv, Ukraine, 61070
Contact       olegkobzev@ukr.net   
Principal Investigator: Oleg Kobziev         
Medical and Preventive Treatment Institution Volyn Regional Oncological Dispensary - Dept of Oncochemotherapy Recruiting
Lutsk, Ukraine, 43018
Contact       ivan.sinielnikov@gmail.com   
Principal Investigator: Ivan Sinielnikov         
CCCH City Oncological Center SHEI Uzhgorod NU - Ch of R&O of Faculty of PGE&PUT Recruiting
Uzhgorod, Ukraine, 88000
Contact       yhotko@gmail.com   
Principal Investigator: Yevhen S Hotko         
Medical center "Oncolife" Recruiting
Zaporizhzhia, Ukraine, 69059
Contact       oleksiikolesnik@gmail.com   
Principal Investigator: Oleksii Kolesnik         
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Layout table for investigator information
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

Additional Information:
Layout table for additonal information
Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT03631706     History of Changes
Other Study ID Numbers: MS200647_0037
2018-001517-32 ( EudraCT Number )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
M7824
Pembrolizumab
PD-L1-tumor Expression
INTR@PID Lung 037
Bintrafusp alfa
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents