New targeted drug shows promise for lung cancer with MET mutations
NCT ID NCT02864992
First seen Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times
Summary
This trial tested the drug tepotinib in 337 people with advanced non-small cell lung cancer that has specific MET gene changes (METex14 skipping or MET amplification). Participants took a 500 mg pill once daily. The main goal was to see if the drug could shrink tumors. The study is active but no longer recruiting, and results are being analyzed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tepotinib
- What this could lead to
- If successful, tepotinib could become a targeted treatment option for people with advanced lung cancer that has specific MET gene changes.
- What could go wrong
- This is a Phase 2 trial, so results are still early. The drug may not work for everyone, and side effects could limit its use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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337 people
The number who actually took part.
- Started
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Sep 2016
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed, written informed consent by participant or legal representative prior to any trial-specific screening procedure * Male or female, greater than or equal to (\>=) 18 years of age (or have reached the age of majority according to local laws and regulations) * Measurable disease confirmed by an independent review committee (IRC) in accordance with RECIST version 1.1 * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * A female participant was 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 participant must agree to use and to have their female partners of childbearing potential to use a highly effective contraception * Histologically or cytologically confirmed advanced (locally advanced or metastatic) NSCLC (all types including squamous and sarcomatoid) * Treatment naïve participant in first-line or pretreated participant with no more than 2 lines of prior therapy * Participants with MET alterations, namely METex14 skipping alterations in plasma and/or tissue as determined by the central laboratory or by an assay with appropriate regulatory status Exclusion Criteria: * Participants with characterized Epidermal Growth Factor Receptor (EGFR) activating mutations that predict sensitivity to anti-EGFR-therapy * Participants with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that predict sensitivity to anti-ALK therapy * Participants with symptomatic brain metastases who are neurologically unstable * 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; * Participants 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 participant from participating in the trial * Participation in another clinical trial within the past 30 days
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Delta
Roeselare, 8800, Belgium
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AZ Delta
Roeselare, Belgium
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Affiliated Tumor Hospital of Harbin Medical University
Harbin, China
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Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
Hefei, China
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Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
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Asklepios Fachkliniken Muenchen-Gauting
Gauting, Germany
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Azienda Ospedaliera San Camillo Forlanini
Roma, Italy
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Azienda Ospedaliera di Padova
Padova, Italy
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Beijing Hospital
Beijing, China
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CHU Ambroise Paré
Mons, 7000, Belgium
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CHU Ambroise Paré
Mons, Belgium
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CHU de Toulouse - Hôpital Larrey
Toulouse, Haute Garonne, 31059, France
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CHU de Toulouse - Hôpital Larrey
Toulouse, France
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California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, 92024, United States
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Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
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Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, Vendee, 85925, France
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Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, France
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Centre Hospitalier Intercommunal de Créteil
Créteil, France
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Centre Hospitalier de Bretagne Sud
Lorient, Morbihan, 56322, France
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Centre Hospitalier de Bretagne Sud
Lorient, France
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Centre Hospitalier de Cholet
Cholet, Maine Et Loire, 49300, France
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Centre Hospitalier de Cholet
Cholet, France
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Centre Hospitalier de la côte Basque
Bayonne, Pyrenees Atlantiques, 64100, France
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Centre Hospitalier de la côte Basque
Bayonne, France
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Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02-781, Poland
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Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, Poland
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Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, Poland
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Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, Germany
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China Medical University Hospital
Taichung, Taiwan
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Chonnam National University Hwasun Hospital
Hwasun-gun, South Korea
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City of Hope Cancer Center
Duarte, California, 91010, United States
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Clinique Mutualiste de l'Estuaire
Saint-Nazaire, Loire Atlantique, 44606, France
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Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
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Community Regional Cancer Care
Indianapolis, Indiana, 46250, United States
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Dong-A University Hospital
Busan, South Korea
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Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
Lublin, Poland
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Evangelisches Krankenhaus Hamm GmbH
Hamm, Germany
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
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For Recruiting Locations in the United States, please Contact U.S. Medical Information
Rockland, Massachusetts, United States
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Gachon University Gil Medical Center
Incheon, South Korea
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Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Pessac, Gironde, 33604, France
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Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Pessac, France
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Guangdong General Hospital
Guangzhou, China
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H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, 33612-9497, United States
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Hackensack University Medical Center PARTNER
Hackensack, New Jersey, 07601, United States
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Hadassah University Hospital - Ein Kerem
Jerusalem, Israel
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Helios Klinikum Erfurt
Erfurt, Germany
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Hokkaido University Hospital
Sapporo, Japan
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Holy Cross Hospital Inc.
Fort Lauderdale, Florida, 33308, United States
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Hopital Albert Calmette - CHU Lille
Lille, Nord, 59037, France
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Hopital Albert Calmette - CHU Lille
Lille, France
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Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
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Hospital General Universitario Gregorio Marañon
Madrid, Spain
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Hospital General Universitario Santa Lucia
Cartagena, Spain
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Hospital General de Catalunya
Sant Cugat del Vallès, Spain
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Hospital Universitari Quiron Dexeus
Barcelona, Spain
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Hospital Universitari Sagrat Cor
Barcelona, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, Spain
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Hospital Universitario 12 de Octubre
Madrid, Spain
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Hospital Universitario HM Madrid Sanchinarro
Madrid, 28050, Spain
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Hospital Universitario HM Madrid Sanchinarro
Madrid, Spain
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Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Spain
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Hospital Universitario La Paz
Madrid, Spain
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Hospital Universitario Nuestra Señora de Valme
Seville, Spain
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Hospital Universitario Virgen Macarena
Seville, 41009, Spain
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Hospital Universitario Virgen Macarena
Seville, Spain
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Hospital de Especialidades de Jerez de la Frontera - Servicio de Oncologia
Jerez de la Frontera, Spain
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Hunan Cancer Hospital
Changsha, China
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Hôpital Saint-Louis
Paris, France
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ICO - Site Paul Papin
Angers, Maine Et Loire, 49055, France
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ICO - Site Paul Papin
Angers, France
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ICO - Site René Gauducheau
Saint-Herblain, Loire Atlantique, 44805, France
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ICO - Site René Gauducheau
Saint-Herblain, France
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IEO Istituto Europeo di Oncologia
Milan, Italy
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IOV - Istituto Oncologico Veneto IRCCS
Padova, Italy
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Ingalls Hospital
Harvey, Illinois, 60426-3558, United States
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Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie
Bern, Switzerland
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Istituto Clinico Humanitas
Rozzano, Italy
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Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, Italy
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Jiangsu Province Hospital
Nanjing, China
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Jilin Cancer Hospital - Oncology
Changchun, China
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Jinan Central Hospital
Jinan, China
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Kanagawa Cancer Center
Yokohama, Japan
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
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Klinikum Chemnitz gGmbH
Chemnitz, Germany
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Korea University Anam Hospital
Seoul, South Korea
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Kosin University Gospel Hospital
Busan, South Korea
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Kurume University Hospital
Kurume-shi, Japan
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Kyungpook National University Medical Center
Daegu, South Korea
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LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg, Austria
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Liaoning Cancer Hospital & Institute
Shenyang, China
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Linyi Tumor Hospital
Linyi, China
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Meir Medical Center
Kfar Saba, Israel
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Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
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Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion
Harrison, New York, 10604, United States
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NHO Kinki-Chuo Chest Medical Center
Sakaishi, Japan
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NHO Kyushu Medical Center
Fukuoka, Japan
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NHO Shikoku Cancer Center
Matsuyama, Japan
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NHO Yamaguchi - Ube Medical Center
Ube-shi, Japan
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NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
Olsztyn, Poland
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Nagoya University Hospital
Nagoya, Japan
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National Cancer Center
Goyang-si, South Korea
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National Cancer Center Hospital East
Kashiwa-shi, Japan
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National Taiwan University Hospital
Taipei, Taiwan
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Niigata Cancer Center Hospital
Niigata, Japan
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Osaka International Cancer Institute
Osaka, Japan
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Ospedale Santa Maria di Cà Foncello
Padova, Italy
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POIS Leipzig GbR
Leipzig, Saxony, 04357, Germany
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POIS Leipzig GbR
Leipzig, Germany
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Peking University Cancer Hospital
Beijing, China
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Pius-Hospital Oldenburg
Oldenburg, Germany
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Prospect Medical Offices, LLC
Midland Park, New Jersey, 07432, United States
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Przychodnia Med-Polonia Sp. z o.o.
Poznan, 60-693, Poland
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Przychodnia Med-Polonia Sp. z o.o.
Poznan, Poland
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Rabin Medical Center-Beilinson Campus
Petah Tikva, Israel
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Regional Cancer Care Associates East Brunswick
East Brunswick, New Jersey, 08816, United States
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Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218, United States
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SRH Wald-Klinikum Gera gGmbH
Gera, Germany
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Saint Louis University
St Louis, Missouri, 63110, United States
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Saint Louis University Cancer Center
St Louis, Missouri, 63110, United States
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Saitama Cancer Center
Kitaadachi-gun, Japan
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Samsung Medical Center
Seoul, South Korea
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Seconda Università degli Studi di Napoli
Naples, Italy
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Seoul National University Bundang Hospital
Seongnam-si, South Korea
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Severance Hospital, Yonsei University
Seoul, South Korea
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Shanghai Cancer Hospital, Fudan University
Shanghai, China
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Sichuan Cancer Hospital
Chengdu, China
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Somerset Hematology Oncology Associates - Somerville Location
East Brunswick, New Jersey, 8816, United States
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Soroka University Medical Center
Beersheba, Israel
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St Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
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St. Joseph Hospital
Orange, California, 92868-4225, United States
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St. Louis Cancer Care, LLP
Bridgeton, Missouri, 63044, United States
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Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, Germany
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Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
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Summit Medical Group, P.A.
Berkeley Heights, New Jersey, 07922, United States
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Swedish Medical Center
Seattle, Washington, 98104, United States
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Taichung Veterans General Hospital
Taichung, Taiwan
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Taipei Veterans General Hospital
Taipei, Taiwan
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Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
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Tennessee Oncology
Nashville, Tennessee, 37203, United States
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Texas Oncology, P.A. - Austin
Austin, Texas, 78731, United States
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Texas Oncology, PA
Beaumont, Texas, 77702-1449, United States
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The Affiliated Cancer Hospital of Xinjiang Medical university
Ürümqi, China
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The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
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The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea
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The Valley Hospital
Ridgewood, New Jersey, 07450, United States
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Torrance Health Association
Redondo Beach, California, 90277, United States
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Tottori University Hospital
Yonago-shi, Japan
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Tri-Service General Hospital
Taipei, Taiwan
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UC Health Clinical Trials Office
Cincinnati, Ohio, 45229, United States
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UZ Antwerpen
Edegem, 2650, Belgium
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UZ Antwerpen
Edegem, Belgium
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Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
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Universitaetsklinikum Heidelberg
Heidelberg, Germany
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Universitaetsklinikum des Saarlandes
Homburg / Saar, Germany
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Universitaetsmedizin Goettingen
Göttingen, Germany
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Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany
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Universitaetsspital Zuerich - Klinik fuer Onkologie
Zurich, Switzerland
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Universitair Medisch Centrum Groningen (UMCG) - Parent
Groningen, Netherlands
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University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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University of Cincinnati - PARENT
Cincinnati, Ohio, 45267-0502, United States
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Università Campus Bio-Medico di Roma
Roma, Italy
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Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis
Bialystok, Poland
-
VU Medisch Centrum
Amsterdam, Netherlands
-
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
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Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson
Wenatchee, Washington, 98801, United States
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Wenatchee Valley Medical Center Oncology
Wenatchee, Washington, 98801, United States
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West China Hospital, Sichuan University
Chengdu, China
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Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Zhejiang Cancer Hospita
Hangzhou, China
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