AzTrials
AzTrials

Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET AmplificationPhase 2NCT02864992

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

A Phase 2 study testing Tepotinib in people with Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification and Lung Adenocarcinoma Stage IIIB/IV, run by EMD Serono Research & Development Institute, Inc. at 176 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tepotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
337 participants
Where
176 sitesin 15 countries
Study dates
13 Sep 2016to 31 Aug 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

176 sites in 15 countries.

176 sites in 15 countries

United States39 sites

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Texas Oncology, P.A. - Austin

    Austin, Texas, 78731

  • Texas Oncology, PA

    Beaumont, Texas, 77702-1449

  • Summit Medical Group, P.A.

    Berkeley Heights, New Jersey, 07922

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • St. Louis Cancer Care, LLP

    Bridgeton, Missouri, 63044

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • UC Health Clinical Trials Office

    Cincinnati, Ohio, 45229

  • University of Cincinnati - PARENT

    Cincinnati, Ohio, 45267-0502

  • Memorial Sloan Kettering Cancer Center - Commack

    Commack, New York, 11725

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80218

  • City of Hope Cancer Center

    Duarte, California, 91010

  • Regional Cancer Care Associates East Brunswick

    East Brunswick, New Jersey, 08816

  • Somerset Hematology Oncology Associates - Somerville Location

    East Brunswick, New Jersey, 8816

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92024

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Holy Cross Hospital Inc.

    Fort Lauderdale, Florida, 33308

  • Hackensack University Medical Center PARTNER

    Hackensack, New Jersey, 07601

  • Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion

    Harrison, New York, 10604

  • Ingalls Hospital

    Harvey, Illinois, 60426-3558

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Community Regional Cancer Care

    Indianapolis, Indiana, 46250

  • Prospect Medical Offices, LLC

    Midland Park, New Jersey, 07432

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022

  • St. Joseph Hospital

    Orange, California, 92868-4225

  • Torrance Health Association

    Redondo Beach, California, 90277

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • For Recruiting Locations in the United States, please Contact U.S. Medical Information

    Rockland, Massachusetts

  • St Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Saint Louis University

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center and Research Institute, Inc

    Tampa, Florida, 33612-9497

  • Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson

    Wenatchee, Washington, 98801

  • Wenatchee Valley Medical Center Oncology

    Wenatchee, Washington, 98801

Other trials in United States

France22 sites

  • ICO - Site Paul Papin

    Angers, Maine Et Loire, 49055

  • ICO - Site Paul Papin

    Angers

  • Centre Hospitalier de la côte Basque

    Bayonne, Pyrenees Atlantiques, 64100

  • Centre Hospitalier de la côte Basque

    Bayonne

  • Centre Hospitalier de Cholet

    Cholet, Maine Et Loire, 49300

  • Centre Hospitalier de Cholet

    Cholet

  • Centre Hospitalier Intercommunal de Créteil

    Créteil

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon, Vendee, 85925

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon

  • Hopital Albert Calmette - CHU Lille

    Lille, Nord, 59037

  • Hopital Albert Calmette - CHU Lille

    Lille

  • Centre Hospitalier de Bretagne Sud

    Lorient, Morbihan, 56322

  • Centre Hospitalier de Bretagne Sud

    Lorient

  • Hôpital Saint-Louis

    Paris

  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque

    Pessac, Gironde, 33604

  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque

    Pessac

  • ICO - Site René Gauducheau

    Saint-Herblain, Loire Atlantique, 44805

  • ICO - Site René Gauducheau

    Saint-Herblain

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, Loire Atlantique, 44606

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, Haute Garonne, 31059

  • CHU de Toulouse - Hôpital Larrey

    Toulouse

Other trials in France

Spain17 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari Quiron Dexeus

    Barcelona

  • Hospital Universitari Sagrat Cor

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital General Universitario Santa Lucia

    Cartagena

  • Hospital de Especialidades de Jerez de la Frontera - Servicio de Oncologia

    Jerez de la Frontera

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, 28050

  • Hospital General Universitario Gregorio Marañon

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga

  • Hospital Universitario Infanta Sofia

    San Sebastián de los Reyes

  • Hospital General de Catalunya

    Sant Cugat del Vallès

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Nuestra Señora de Valme

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

Other trials in Spain

China16 sites

  • Beijing Hospital

    Beijing

  • Peking University Cancer Hospital

    Beijing

  • Jilin Cancer Hospital - Oncology

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Sichuan Cancer Hospital

    Chengdu

  • West China Hospital, Sichuan University

    Chengdu

  • Guangdong General Hospital

    Guangzhou

  • Zhejiang Cancer Hospita

    Hangzhou

  • Affiliated Tumor Hospital of Harbin Medical University

    Harbin

  • Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital

    Hefei

  • Jinan Central Hospital

    Jinan

  • Linyi Tumor Hospital

    Linyi

  • Jiangsu Province Hospital

    Nanjing

  • Shanghai Cancer Hospital, Fudan University

    Shanghai

  • Liaoning Cancer Hospital & Institute

    Shenyang

  • The Affiliated Cancer Hospital of Xinjiang Medical university

    Ürümqi

Other trials in China

Germany15 sites

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin

  • Klinikum Chemnitz gGmbH

    Chemnitz

  • Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

    Dresden

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden

  • Helios Klinikum Erfurt

    Erfurt

  • Asklepios Fachkliniken Muenchen-Gauting

    Gauting

  • SRH Wald-Klinikum Gera gGmbH

    Gera

  • Universitaetsmedizin Goettingen

    Göttingen

  • Evangelisches Krankenhaus Hamm GmbH

    Hamm

  • Universitaetsklinikum Heidelberg

    Heidelberg

  • Universitaetsklinikum des Saarlandes

    Homburg / Saar

  • POIS Leipzig GbR

    Leipzig, Saxony, 04357

  • POIS Leipzig GbR

    Leipzig

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz

  • Pius-Hospital Oldenburg

    Oldenburg

Other trials in Germany

Japan13 sites

  • NHO Kyushu Medical Center

    Fukuoka

  • National Cancer Center Hospital East

    Kashiwa-shi

  • Saitama Cancer Center

    Kitaadachi-gun

  • Kurume University Hospital

    Kurume-shi

  • NHO Shikoku Cancer Center

    Matsuyama

  • Nagoya University Hospital

    Nagoya

  • Niigata Cancer Center Hospital

    Niigata

  • Osaka International Cancer Institute

    Osaka

  • NHO Kinki-Chuo Chest Medical Center

    Sakaishi

  • Hokkaido University Hospital

    Sapporo

  • NHO Yamaguchi - Ube Medical Center

    Ube-shi

  • Kanagawa Cancer Center

    Yokohama

  • Tottori University Hospital

    Yonago-shi

Other trials in Japan

South Korea12 sites

  • Dong-A University Hospital

    Busan

  • Kosin University Gospel Hospital

    Busan

  • Kyungpook National University Medical Center

    Daegu

  • National Cancer Center

    Goyang-si

  • Chonnam National University Hwasun Hospital

    Hwasun-gun

  • Gachon University Gil Medical Center

    Incheon

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Korea University Anam Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Severance Hospital, Yonsei University

    Seoul

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon

Other trials in South Korea

Italy11 sites

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genova

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

  • IEO Istituto Europeo di Oncologia

    Milan

  • Seconda Università degli Studi di Napoli

    Naples

  • Azienda Ospedaliera di Padova

    Padova

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova

  • Ospedale Santa Maria di Cà Foncello

    Padova

  • Azienda Ospedaliera San Camillo Forlanini

    Roma

  • Università Campus Bio-Medico di Roma

    Roma

  • Istituto Clinico Humanitas

    Rozzano

Other trials in Italy

Poland8 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis

    Bialystok

  • Centrum Pulmonologii i Torakochirurgii w Bystrej

    Bystra

  • Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska

    Lublin

  • NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

    Olsztyn

  • Przychodnia Med-Polonia Sp. z o.o.

    Poznan, 60-693

  • Przychodnia Med-Polonia Sp. z o.o.

    Poznan

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw, 02-781

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw

Other trials in Poland

Belgium6 sites

  • UZ Antwerpen

    Edegem, 2650

  • UZ Antwerpen

    Edegem

  • CHU Ambroise Paré

    Mons, 7000

  • CHU Ambroise Paré

    Mons

  • AZ Delta

    Roeselare, 8800

  • AZ Delta

    Roeselare

Other trials in Belgium

Taiwan6 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

Israel5 sites

  • Soroka University Medical Center

    Beersheba

  • Hadassah University Hospital - Ein Kerem

    Jerusalem

  • Meir Medical Center

    Kfar Saba

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Netherlands3 sites

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam

  • VU Medisch Centrum

    Amsterdam

  • Universitair Medisch Centrum Groningen (UMCG) - Parent

    Groningen

Other trials in Netherlands

Switzerland2 sites

  • Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie

    Bern

  • Universitaetsspital Zuerich - Klinik fuer Onkologie

    Zurich

Other trials in Switzerland

Austria1 site

  • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

    Salzburg

Other trials in Austria

About this study

Official title: A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures 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.

Read the detailed description

The study included 3 cohorts with one primary endpoint (Objective Response Rate). Enrollment number and completion data is changed by new cohorts.

Being tested
Tepotinib
Keywords
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, non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TepotinibDrug

    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.

Study groups in NCT02864992
Study groupRoleWhat they receive
Part 1: Cohort A: METex14 Skipping AlterationsOtherParticipants 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.
Receives: Drug: Tepotinib
Part 1: Cohort B: MET AmplificationOtherParticipants 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.
Receives: Drug: Tepotinib
Part 2: Cohort C: Confirmatory Part for METex14 Skipping AlterationsOtherParticipants 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.
Receives: Drug: Tepotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)

    Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study 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 was 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.

    Measured: Time from first treatment up to data cutoff (approximately Month 66)

  2. Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)

    Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study 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 was 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.

    Measured: Time from first treatment up to data cutoff (approximately Month 66)

  3. Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)

    Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study 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 was 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.

    Measured: Time from first treatment up to data cutoff (approximately Month 66)

Secondary outcomes (14)

  1. Part 1 & 2: Cohort A + B + C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

    Measured: Time from first treatment up to end of study (approximately Month 101)

  2. Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator

    Measured: Time from first treatment up to end of study (approximately Month 101)

  3. Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by IRC

    Measured: Time from first treatment up to end of study (approximately Month 101)

  4. Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by Investigator

    Measured: Time from first treatment up to end of study (approximately Month 101)

  5. Part 1 & 2: Cohort A + B + C: Progression-free Survival by IRC Assessment

    Measured: Time from first treatment up to end of study (approximately Month 101)

  6. Part 1 & 2: Cohort A + B +C: Progression-free Survival by Investigator Assessment

    Measured: Time from first treatment up to end of study (approximately Month 101)

  7. Part 1 & 2: Cohort A + B + C: Overall Survival (OS)

    Measured: Time from first treatment up to end of study (approximately Month 101)

  8. Part 1 & 2: Cohort A + B + C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death

    Measured: Time from first treatment up to end of study (approximately Month 101)

  9. Part 1 & 2: Cohort A + B +C: Number of Participants With Markedly Abnormal Clinical Laboratory Tests

    Measured: Time from first treatment up to end of study (approximately Month 101)

  10. Part 1 & 2: Cohort A + B + C: Number of Participants With Markedly Abnormal Vital Signs and Physical Examination

    Measured: Time from first treatment up to end of study (approximately Month 101)

  11. Part 1 & 2: Cohort A + B + C: Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)

    Measured: Time from first treatment up to end of study (approximately Month 101)

  12. Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score

    Measured: Time from first treatment up to end of study (approximately Month 101)

  13. Part 1 & 2: Cohort A + B + C: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Measured: Time from first treatment up to end of study (approximately Month 101)

  14. Part 1 & 2: Cohort A + B + C: Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Measured: Time from first treatment up to end of study (approximately Month 101)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2016 (estimated)
  2. Study start13 Sep 2016
  3. Primary completion16 May 2022
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02864992
Sponsor's protocol ID
MS200095-0022
Other IDs
2015-005696-24, 2024-512003-39-00, Japic CTI-163370, jRCT2080223315, CTR20192576, 2015
Status last verified
Jun 2026
First submitted
29 Jul 2016
Last updated
14 Jul 2026
Data monitoring committee
Yes
Individual data sharing
Yes: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Publications

  • 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.

    PubMed 32469185

  • 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.

    PubMed 38575731

  • 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.

    PubMed 37944528

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Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tepotinib in people with Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification and Lung Adenocarcinoma Stage IIIB/IV, run by EMD Serono Research & Development Institute, Inc. at 176 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, France, Spain, China, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC) (time frame: Time from first treatment up to data cutoff (approximately Month 66)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864992, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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