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Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations (VISION)

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: NCT02864992
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer. This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.

Condition or disease Intervention/treatment Phase
Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer With MET Exon 14 (METex14) Skipping Alterations or MET Amplification Drug: Tepotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm Trial to Investigate Tepotinib in Advanced ( Stage IIIB/IV) Non-small Cell Lung Cancer With MET-exon-14 (METex14) Skipping Alterations or MET Amplification (VISION)
Actual Study Start Date : September 13, 2016
Estimated Primary Completion Date : June 25, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Tepotinib Drug: Tepotinib
Subjects will receive 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.




Primary Outcome Measures :
  1. Objective response as assessed by independent review committee [ Time Frame: Baseline up to 20 months ]
    Objective response will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and as adjudicated by an Independent review committee. Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.


Secondary Outcome Measures :
  1. Objective response assessed as per Investigator [ Time Frame: Baseline up to 20 months ]
    Objective response will be determined according to RECIST 1.1 and as per investigator's discretion. Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

  2. Duration of response as assessed by independent review committee [ Time Frame: Baseline until PD/ death within 84 days of last tumor assessment; assessed up to 20 months ]
    Duration of response according to RECIST 1.1 and as adjudicated by an Independent review committee is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

  3. Duration of response as assessed by investigator [ Time Frame: Baseline until PD/ death within 84 days of last tumor assessment; assessed up to 20 months ]
    Duration of response according to RECIST 1.1 and as per investigator's discretion is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

  4. Objective disease control as assessed by independent review committee [ Time Frame: Baseline up to 20 months ]
    Objective disease control will be determined according to RECIST 1.1 and as adjudicated by an Independent review committee. Objective disease control is defined as either a confirmed CR or PR, or stable disease (SD) lasting at least 12 weeks (84 days) as assessed by independent review committee. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

  5. Objective disease control as assessed by investigator [ Time Frame: Baseline up to 20 months ]
    Objective disease control will be determined according to RECIST 1.1 and as per investigator's discretion. Objective disease control is defined as either a confirmed CR or PR, or stable disease (SD) lasting at least 12 weeks (84 days) as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

  6. Progression free survival as assessed by independent review committee [ Time Frame: Baseline until PD or death within 84 days of last tumor assessment; assessed up to 20 months ]
    Progression free survival as assessed by independent review committee is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (based on independent review) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

  7. Progression free survival as assessed by investigator [ Time Frame: Baseline until PD or death within 84 days of last tumor assessment; assessed up to 20 months ]
    Progression free survival as assessed by investigator is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (as assessed by investigator) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

  8. Overall survival [ Time Frame: Baseline until death, assessed up to 20 months ]
    Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.

  9. Occurrence of Treatment emergent adverse event (TEAEs) and deaths [ Time Frame: From the first dose of study drug administration until 33 days after the last dose of study drug administration, assessed up to 20 Months ]
    This outcome measure will be presented as the percentage of subjects with any (serious) adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.

  10. Percentage of subjects with of markedly abnormal clinical laboratory tests, vital signs, Electrocardiogram (ECG) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Baseline up to 20 months ]
    This outcome measure will be presented as the percentage of subjects with markedly abnormal vital sign measurements. Percentages are calculated using total number of subjects per treatment cohort as the denominator. Abnormalities in clinical laboratory tests will be measured as hematology and coagulation, biochemistry and urinalysis. Abnormalities in Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, body temperature as a part of vital signs; electrocardiogram (ECG) wave, body weight, and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), and clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis) will be assessed.

  11. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline up to 20 months ]
  12. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: Baseline up to 20 months ]
  13. EuroQol Five Dimension Five Level Scale (EQ5D5L) [ Time Frame: Baseline up to 20 months ]
  14. Maximum Plasma concentration (Cmax) of drug [ Time Frame: pre-dose, at 1.5 hours post-dose and at 4 hours post-dose on Cycle 1, Day 1 and on Cycle 2, Day 1 ]
  15. Trough plasma concentration (Ctrough) of drug [ Time Frame: pre-dose, at 1.5 hours post-dose and at 4 hours post-dose on Cycle 1, Day 1 and on Cycle 2, Day 1 ]
  16. Number of subjects with markedly abnormal clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis). [ Time Frame: Baseline up to 20 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed, written informed consent by subject or legal representative prior to any trial-specific screening procedure
  • Male or female, greater than or equal to (>=) 18 years of age (or having reached the age of majority according to local laws and regulations
  • Measurable disease in accordance with RECIST version 1.1
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential OR
  • A woman of childbearing potential who agrees to use a highly effective contraception
  • A male subject must agree to use and to have their female partners of childbearing potential to use a highly effective contraception
  • Histologically confirmed advanced (Stage IIIB/IV) Non-small Cell Lung Cancer NSCLC (all histologies including squamous and sarcomatoid)
  • Treatment naïve patients in first-line or pretreated patients with no more than 2 lines of prior therapy
  • Subjects with MET alterations, namely METex14 skipping alterations in plasma and/or tissue, or MET amplification only in plasma and/or tumor biopsy samplet

Exclusion Criteria:

  • Subjects with characterized Epidermal Growth Factor Receptor (EGFR) activating mutations that predict sensitivity to anti-EGFR-therapy
  • Subjects with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that predict sensitivity to anti-ALK therapy
  • Active brain metastases
  • Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy
  • Need for transfusion within 14 days prior to the first dose of trial treatment
  • Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for anti-cancer purposes, targeted therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of trial treatment;
  • Subjects who have brain metastasis as the only measurable lesion
  • Inadequate hematological, liver, renal, cardiac function
  • Prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met pathway
  • Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg)
  • Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC), except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years
  • Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the test product
  • Major surgery within 28 days prior to Day 1 of trial treatment
  • Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C virus
  • Substance abuse, active infection, or other acute or chronic medical or psychiatric condition or laboratory abnormalities that might increase the risk associated with trial participation at the discretion of Investigators
  • Known hypersensitivity to any of the trial treatment ingredients
  • Legal incapacity or limited legal capacity
  • Any other reason that, in the opinion of the Principal Investigator, precludes the subject from participating in the trial
  • Participation in another clinical trial within the past 30 days

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): NCT02864992


Contacts
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Contact: US Medical Information 888-275-7376
Contact: Merck KGaA Communication Center +49 6151 72 5200 service@merckgroup.com

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Locations
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United States, California
City of Hope Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Ravi Salgia    626-218-3712    rsalgia@coh.org   
Principal Investigator: Ravi Salgia         
UCI Medical Center Withdrawn
Orange, California, United States, 92868
Torrance Health Association Recruiting
Redondo Beach, California, United States, 90277
Contact: Andrew Horodner    310-750-3300    ahorodner@yahoo.com   
Principal Investigator: Andrew Horodner         
United States, Colorado
Rocky Mountain Cancer Centers, LLP Recruiting
Denver, Colorado, United States, 80218
Principal Investigator: Robert Jotte         
United States, Florida
Holy Cross Hospital Inc. Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: David Drew    954-267-7742    guchuan@hotmail.com   
Principal Investigator: David Drew         
United States, Georgia
University Cancer & Blood Center, LLC Withdrawn
Athens, Georgia, United States, 30607
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Conor Steuer         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Jyoti Patel         
Ingalls Hospital Recruiting
Harvey, Illinois, United States, 60426-3558
Principal Investigator: Mark Kozloff         
United States, Indiana
Community Regional Cancer Care Recruiting
Indianapolis, Indiana, United States, 46250
Principal Investigator: Rhadika Walling         
United States, Missouri
St. Louis Cancer Care, LLP Recruiting
Bridgeton, Missouri, United States, 63044
Principal Investigator: Juan Cuevas         
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Nishant Poddar         
United States, New Jersey
Hackensack University Medical Center PARTNER Recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: Harry Harper         
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Principal Investigator: Eli Kirshner         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10022
Contact: Paul Paik    646-888-4202    paikp@mskcc.org   
Principal Investigator: Paul Paik         
United States, Ohio
UC Health Clinical Trials Office Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: John Morris         
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Melissa Johnson         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Leora Horn         
United States, Texas
Texas Oncology, P.A. - Austin Recruiting
Austin, Texas, United States, 78731
Principal Investigator: James Uyeki         
Texas Oncology, PA Recruiting
Beaumont, Texas, United States, 77702-1449
Principal Investigator: Jesse Medellin         
Texas Oncology, P.A. Withdrawn
Dallas, Texas, United States, 75231
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Xiuning Le         
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Principal Investigator: Alexander Spira         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Principal Investigator: Howard West         
Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson Recruiting
Wenatchee, Washington, United States, 98801
Contact: Lindsay Overton    509-663-8711    lindsay.overton@confluencehealth.org   
Principal Investigator: Lindsay Overton         
Belgium
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Principal Investigator: Jan Van Meerbeeck         
CHU Ambroise Paré Recruiting
Mons, Belgium, 7000
Contact: Mayné David    +3265417514    david.mayne@hap.be   
Principal Investigator: Stephanie Holbrechts         
AZ Delta Recruiting
Roeselare, Belgium, 8800
Contact: Ingel Demedts    +3251237139    ingel.demedts@azdelta.be   
Principal Investigator: Ingel Demedts         
France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque Recruiting
Pessac, Gironde, France, 33604
Principal Investigator: Remi Veillon         
CHU de Toulouse - Hôpital Larrey Recruiting
Toulouse, Haute Garonne, France, 31059
Principal Investigator: Julien Mazières         
ICO - Site René Gauducheau Recruiting
Saint Herblain, Loire Atlantique, France, 44805
Principal Investigator: Helene Senellart         
Clinique Mutualiste de l'Estuaire Recruiting
Saint Nazaire Cedex, Loire Atlantique, France, 44606
Principal Investigator: Thierry Chatellier         
ICO - Site Paul Papin Recruiting
Angers Cedex 2, Maine Et Loire, France, 49055
Principal Investigator: Helene Senellart         
Centre Hospitalier de Cholet Recruiting
Cholet, Maine Et Loire, France, 49300
Principal Investigator: Philippe Masson         
Centre Hospitalier de Bretagne Sud Recruiting
Lorient cedex, Morbihan, France, 56322
Principal Investigator: Régine Lamy         
Hopital Albert Calmette - CHU Lille Recruiting
Lille Cedex, Nord, France, 59037
Principal Investigator: Alexis Cortot         
Hôpital Saint-Louis Recruiting
Paris Cedex 10, Paris, France, 75475
Principal Investigator: Ludovic Doucet         
Centre Hospitalier de la côte Basque Recruiting
Bayonne, Pyrenees Atlantiques, France, 64100
Contact: Sophia Schneider    +33559443158    sschneider@ch-cotebasque.fr   
Principal Investigator: Sophia Schneider         
Centre Hospitalier Intercommunal de Créteil Recruiting
Creteil cedex, Val De Marne, France, 94010
Principal Investigator: Christos Chouaid         
Centre Hospitalier Départemental Les Oudairies Recruiting
La Roche sur Yon, Vendee, France, 85925
Principal Investigator: Acya Bizieux         
Germany
Universitaetsklinikum Heidelberg Not yet recruiting
Heidelberg, Baden Wuerttemberg, Germany, 69126
Principal Investigator: Michael Thomas         
Asklepios Fachkliniken Muenchen-Gauting Recruiting
Gauting, Bayern, Germany, 82131
Principal Investigator: Niels Reinmuth         
Universitaetsmedizin Goettingen Not yet recruiting
Goettingen, Niedersachsen, Germany, 37075
Principal Investigator: Tobias Raphael Overbeck         
Pius-Hospital Oldenburg Recruiting
Oldenburg, Niedersachsen, Germany, 26121
Principal Investigator: Frank Griesinger         
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Not yet recruiting
Mainz, Rheinland Pfalz, Germany, 55101
Principal Investigator: Juergen Alt         
Universitaetsklinikum des Saarlandes Recruiting
Homburg / Saar, Saarland, Germany, 66421
Principal Investigator: Sven Henschke         
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Sachsen, Germany, 09113
Principal Investigator: Stefan Hammerschmidt         
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt Recruiting
Dresden, Sachsen, Germany, 01067
Principal Investigator: Harald Schmalenberg         
Universitaetsklinikum Carl Gustav Carus TU Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Principal Investigator: Martin Wermke         
POIS Leipzig GbR Recruiting
Leipzig, Sachsen, Germany, 04357
Principal Investigator: Christian Gessner         
Helios Klinikum Erfurt Recruiting
Erfurt, Thueringen, Germany, 99089
Principal Investigator: Bernd Mross         
SRH Wald-Klinikum Gera gGmbH Recruiting
Gera, Thueringen, Germany, 07548
Principal Investigator: Susanne Lang         
Charite Universitaetsmedizin Berlin - Campus Charite Mitte Recruiting
Berlin, Germany, 10117
Principal Investigator: Sebastian Ochsenreither         
Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Principal Investigator: Giovanna Finocchiaro         
Ospedale Valduce Recruiting
Como, Italy, 22100
Principal Investigator: Clelia Casartelli         
Istituto Nazionale per la Ricerca sul Cancro di Genova Recruiting
Genova, Italy, 16132
Principal Investigator: Francesco Grossi         
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Contact: Marina Garassino    +390223903066    garassino.studiclinici@istitutotumori.mi.it   
Principal Investigator: Marina Garassino         
IEO Istituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Principal Investigator: Filippo de Marinis         
Seconda Università degli Studi di Napoli Recruiting
Napoli, Italy, 80131
Principal Investigator: Fortunato Ciardiello         
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Principal Investigator: Federico Rea         
IOV - Istituto Oncologico Veneto IRCCS Recruiting
Padova, Italy, 35128
Principal Investigator: Pierfranco Conte         
Ospedale Santa Maria di Cà Foncello Recruiting
Padova, Italy, 35128
Principal Investigator: Adolfo Favaretto         
Università Campus Bio-Medico di Roma Recruiting
Roma, Italy, 00128
Principal Investigator: Giuseppe Tonini         
Azienda Ospedaliera San Camillo Forlanini Recruiting
Roma, Italy, 00149
Principal Investigator: Maria Rita Migliorino         
Japan
Nagoya University Hospital Recruiting
Nagoya-shi, Aichi-Ken, Japan, 466-8560
Principal Investigator: Masahiro Morise         
National Cancer Center Hospital East Recruiting
Kashiwa-shi, Chiba-Ken, Japan, 277-8577
Principal Investigator: Shingo Matsumoto         
NHO Shikoku Cancer Center Recruiting
Matsuyama-shi, Ehime-Ken, Japan, 791-0280
Principal Investigator: Toshiyuki Kozuki         
NHO Kyushu Medical Center Recruiting
Fukuoka-shi, Fukuoka-Ken, Japan, 810-8563
Principal Investigator: Masao Ichiki         
Kurume University Hospital Recruiting
Kurume-shi, Fukuoka-Ken, Japan, 830-0011
Principal Investigator: Takaaki Tokito         
Hokkaido University Hospital Recruiting
Sapporo-shi, Hokkaido, Japan, 060-8648
Principal Investigator: Naofumi Shinagawa         
Kanagawa Cancer Center Recruiting
Yokohama-shi, Kanagawa-Ken, Japan, 241-8515
Principal Investigator: Terufumi Kato         
Niigata Cancer Center Hospital Recruiting
Niigata-shi, Niigata-Ken, Japan, 951-8566
Principal Investigator: Hiroshi Tanaka         
Osaka International Cancer Institute Recruiting
Osaka-shi, Osaka-Fu, Japan, 541-8567
Principal Investigator: Toru Kumagai         
NHO Kinki-Chuo Chest Medical Center Recruiting
Sakai-shi, Osaka-Fu, Japan, 591-8555
Principal Investigator: Shinji Atagi         
Saitama Cancer Center Recruiting
Kitaadachi-gun, Saitama-Ken, Japan, 362-0806
Principal Investigator: Hiroshi Sakai         
Tottori University Hospital Recruiting
Yonago-shi, Tottori-Ken, Japan, 683-8504
Principal Investigator: Tomohiro Sakamoto         
NHO Yamaguchi - Ube Medical Center Recruiting
Ube-shi, Yamaguchi-Ken, Japan, 755-0241
Principal Investigator: Kenichi Chikamori         
Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej Recruiting
Bystra, Poland, 43-360
Principal Investigator: Adam Pawlak         
Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska Recruiting
Lublin, Poland, 20-093
Principal Investigator: Slawomir Mandziuk         
NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o Recruiting
Olsztyn, Poland, 10-513
Principal Investigator: Malgorzata Suszko-Kazarnowicz         
Przychodnia Med-Polonia Sp. z o.o. Recruiting
Poznan, Poland, 60-693
Contact: Rodryg Ramlau    +48616654316    rramlau@gmail.com   
Principal Investigator: Rodryg Ramlau         
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Recruiting
Warszawa, Poland, 02-781
Principal Investigator: Dariusz Kowalski         
Spain
Hospital General de Catalunya Recruiting
Sant Cugat del Valles, Barcelona, Spain, 08190
Principal Investigator: Irene Moya Horno         
Hospital Universitario HM Puerta del Sur Recruiting
Mostoles, Madrid, Spain, 28938
Principal Investigator: Ana Collazo Lorduy         
Hospital Universitario Infanta Sofia Recruiting
San Sebastian de los Reyes, Madrid, Spain, 28702
Principal Investigator: Maria Sereno Moyano         
Hospital General Universitario Santa Lucia Recruiting
Cartagena, Murcia, Spain, 30202
Principal Investigator: Edith Rodriguez Braun         
Hospital Clinico Universitario Virgen de la Victoria Recruiting
Malaga, Málaga, Spain, 29010
Principal Investigator: Jose Manuel Trigo Perez         
Hospital Universitari Quiron Dexeus Recruiting
Barcelona, Spain, 08028
Principal Investigator: Santiago Viteri Ramirez         
Hospital Universitari Sagrat Cor Recruiting
Barcelona, Spain, 08029
Principal Investigator: Niki Karachaliou         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Enriqueta Felip Font    +34932746085    efelip@vhebron.net   
Principal Investigator: Enriqueta Felip Font         
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Principal Investigator: Rosa Alvarez Alvarez         
MD Anderson Cancer Centre Recruiting
Madrid, Spain, 28033
Principal Investigator: Pilar Lopez Criado         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Principal Investigator: Luis Paz-Ares Rodriguez         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Principal Investigator: Javier de Castro Carpeño         
Hospital Universitario HM Madrid Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Javier de Castro Carpeño    +34917277516    javier.decastro@salud.madrid.org   
Principal Investigator: Javier de Castro Carpeño         
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Principal Investigator: David Vicente Baz         
Hospital Universitario Nuestra Señora de Valme Recruiting
Sevilla, Spain, 41014
Principal Investigator: Jose Fuentes Pradera         
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT02864992     History of Changes
Other Study ID Numbers: MS200095-0022
2015-005696-24 ( EudraCT Number )
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
lung
neoplasm
cancer
tumor
adenocarcinoma
MET exon 14
METex14
pulmonary
stage III
stage IV
c-Met
cMET
NSCLC
advanced non-small cell lung cancer
MET amplification
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