Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
NCT ID: NCT02864992
Last Updated: 2025-12-23
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
337 participants
INTERVENTIONAL
2016-09-13
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1: Cohort A: METex14 Skipping Alterations
Participants received 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.
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.
Part 1: Cohort B: MET Amplification
Participants received 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.
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.
Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations
Participants received 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany
Locations
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City of Hope Cancer Center
Duarte, California, United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States
St. Joseph Hospital
Orange, California, United States
Torrance Health Association
Redondo Beach, California, United States
St Joseph Heritage Healthcare
Santa Rosa, California, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Ingalls Hospital
Harvey, Illinois, United States
Community Regional Cancer Care
Indianapolis, Indiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
For Recruiting Locations in the United States, please Contact U.S. Medical Information
Rockland, Massachusetts, United States
St. Louis Cancer Care, LLP
Bridgeton, Missouri, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Summit Medical Group, P.A.
Berkeley Heights, New Jersey, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Regional Cancer Care Associates East Brunswick
East Brunswick, New Jersey, United States
Somerset Hematology Oncology Associates - Somerville Location
East Brunswick, New Jersey, United States
Hackensack University Medical Center PARTNER
Hackensack, New Jersey, United States
Prospect Medical Offices, LLC
Midland Park, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UC Health Clinical Trials Office
Cincinnati, Ohio, United States
University of Cincinnati - PARENT
Cincinnati, Ohio, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology, P.A. - Austin
Austin, Texas, United States
Texas Oncology, PA
Beaumont, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson
Wenatchee, Washington, United States
Wenatchee Valley Medical Center Oncology
Wenatchee, Washington, United States
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg, , Austria
UZ Antwerpen
Edegem, , Belgium
UZ Antwerpen
Edegem, , Belgium
CHU Ambroise Paré
Mons, , Belgium
CHU Ambroise Paré
Mons, , Belgium
AZ Delta
Roeselare, , Belgium
AZ Delta
Roeselare, , Belgium
Beijing Hospital
Beijing, , China
Peking University Cancer Hospital
Beijing, , China
Jilin Cancer Hospital - Oncology
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
Sichuan Cancer Hospital
Chengdu, , China
West China Hospital, Sichuan University
Chengdu, , China
Guangdong General Hospital
Guangzhou, , China
Zhejiang Cancer Hospita
Hangzhou, , China
Affiliated Tumor Hospital of Harbin Medical University
Harbin, , China
Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
Hefei, , China
Jinan Central Hospital
Jinan, , China
Linyi Tumor Hospital
Linyi, , China
Jiangsu Province Hospital
Nanjing, , China
Shanghai Cancer Hospital, Fudan University
Shanghai, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
The Affiliated Cancer Hospital of Xinjiang Medical university
Ürümqi, , China
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Pessac, Gironde, France
CHU de Toulouse - Hôpital Larrey
Toulouse, Haute Garonne, France
ICO - Site René Gauducheau
Saint-Herblain, Loire Atlantique, France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, Loire Atlantique, France
ICO - Site Paul Papin
Angers, Maine Et Loire, France
Centre Hospitalier de Cholet
Cholet, Maine Et Loire, France
Centre Hospitalier de Bretagne Sud
Lorient, Morbihan, France
Hopital Albert Calmette - CHU Lille
Lille, Nord, France
Centre Hospitalier de la côte Basque
Bayonne, Pyrenees Atlantiques, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, Vendee, France
ICO - Site Paul Papin
Angers, , France
Centre Hospitalier de la côte Basque
Bayonne, , France
Centre Hospitalier de Cholet
Cholet, , France
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, , France
Hopital Albert Calmette - CHU Lille
Lille, , France
Centre Hospitalier de Bretagne Sud
Lorient, , France
Hôpital Saint-Louis
Paris, , France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Pessac, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, , France
CHU de Toulouse - Hôpital Larrey
Toulouse, , France
POIS Leipzig GbR
Leipzig, Saxony, Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
Asklepios Fachkliniken Muenchen-Gauting
Gauting, , Germany
SRH Wald-Klinikum Gera gGmbH
Gera, , Germany
Universitaetsmedizin Goettingen
Göttingen, , Germany
Evangelisches Krankenhaus Hamm GmbH
Hamm, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum des Saarlandes
Homburg / Saar, , Germany
POIS Leipzig GbR
Leipzig, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Pius-Hospital Oldenburg
Oldenburg, , Germany
Soroka University Medical Center
Beersheba, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
IEO Istituto Europeo di Oncologia
Milan, , Italy
Seconda Università degli Studi di Napoli
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, , Italy
Ospedale Santa Maria di Cà Foncello
Padua, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Università Campus Bio-Medico di Roma
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
NHO Kyushu Medical Center
Fukuoka, , Japan
National Cancer Center Hospital East
Kashiwa-shi, , Japan
Saitama Cancer Center
Kitaadachi-gun, , Japan
Kurume University Hospital
Kurume-shi, , Japan
NHO Shikoku Cancer Center
Matsuyama, , Japan
Nagoya University Hospital
Nagoya, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Osaka International Cancer Institute
Osaka, , Japan
NHO Kinki-Chuo Chest Medical Center
Sakaishi, , Japan
Hokkaido University Hospital
Sapporo, , Japan
NHO Yamaguchi - Ube Medical Center
Ube-shi, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
Tottori University Hospital
Yonago-shi, , Japan
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
VU Medisch Centrum
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen (UMCG) - Parent
Groningen, , Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis
Bialystok, , Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, , Poland
Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
Lublin, , Poland
NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
Olsztyn, , Poland
Przychodnia Med-Polonia Sp. z o.o.
Poznan, , Poland
Przychodnia Med-Polonia Sp. z o.o.
Poznan, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, , Poland
Dong-A University Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Kyungpook National University Medical Center
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitari Quiron Dexeus
Barcelona, , Spain
Hospital Universitari Sagrat Cor
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Santa Lucia
Cartagena, , Spain
Hospital de Especialidades de Jerez de la Frontera - Servicio de Oncologia
Jerez de la Frontera, , Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, , Spain
Hospital General de Catalunya
Sant Cugat del Vallès, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Nuestra Señora de Valme
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie
Bern, , Switzerland
Universitaetsspital Zuerich - Klinik fuer Onkologie
Zurich, , Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Countries
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References
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Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, Mazieres J, Viteri S, Senellart H, Van Meerbeeck J, Raskin J, Reinmuth N, Conte P, Kowalski D, Cho BC, Patel JD, Horn L, Griesinger F, Han JY, Kim YC, Chang GC, Tsai CL, Yang JC, Chen YM, Smit EF, van der Wekken AJ, Kato T, Juraeva D, Stroh C, Bruns R, Straub J, Johne A, Scheele J, Heymach JV, Le X. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943. doi: 10.1056/NEJMoa2004407. Epub 2020 May 29.
Kato T, Yang JC, Ahn MJ, Sakai H, Morise M, Chen YM, Han JY, Yang JJ, Zhao J, Hsia TC, Berghoff K, Bruns R, Vioix H, Lang S, Johne A, Le X, Paik PK. Efficacy and safety of tepotinib in Asian patients with advanced NSCLC with MET exon 14 skipping enrolled in VISION. Br J Cancer. 2024 Jun;130(10):1679-1686. doi: 10.1038/s41416-024-02615-9. Epub 2024 Apr 4.
Le X, Paz-Ares LG, Van Meerbeeck J, Viteri S, Galvez CC, Smit EF, Garassino M, Veillon R, Baz DV, Pradera JF, Sereno M, Kozuki T, Kim YC, Yoo SS, Han JY, Kang JH, Son CH, Choi YJ, Stroh C, Juraeva D, Vioix H, Bruns R, Otto G, Johne A, Paik PK. Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B. Cell Rep Med. 2023 Nov 21;4(11):101280. doi: 10.1016/j.xcrm.2023.101280. Epub 2023 Nov 8.
Mazieres J, Paik PK, Garassino MC, Le X, Sakai H, Veillon R, Smit EF, Cortot AB, Raskin J, Viteri S, Wu YL, Yang JCH, Ahn MJ, Ma R, Zhao J, O'Brate A, Berghoff K, Bruns R, Otto G, Johne A, Felip E, Thomas M. Tepotinib Treatment in Patients With MET Exon 14-Skipping Non-Small Cell Lung Cancer: Long-term Follow-up of the VISION Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2023 Sep 1;9(9):1260-1266. doi: 10.1001/jamaoncol.2023.1962.
Hallick J, Baird AM, Falchook G, Le X, Hong D, Viteri S, Raskin J, Reinmuth N, Vlassak S, Militaru M, Paik PK. Plain language summary of the development of tepotinib: a treatment for a subtype of non-small cell lung cancer called MET exon 14 skipping. Future Oncol. 2023 Mar;19(10):683-696. doi: 10.2217/fon-2022-1035. Epub 2023 Mar 31.
Xiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30.
Xiong W, Papasouliotis O, Jonsson EN, Strotmann R, Girard P. Population pharmacokinetic analysis of tepotinib, an oral MET kinase inhibitor, including data from the VISION study. Cancer Chemother Pharmacol. 2022 May;89(5):655-669. doi: 10.1007/s00280-022-04423-5. Epub 2022 Apr 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Targeting MET Clinical Trial Program
Redacted Clinical study report, redacted clinical study protocol and redacted statistical analysis plan for this study is also available at the HC-PRCI portal (Health Canada-Public release of clinical information)
Other Identifiers
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2015-005696-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-512003-39-00
Identifier Type: CTIS
Identifier Source: secondary_id
MS200095-0022
Identifier Type: -
Identifier Source: org_study_id