Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

March 23, 2026 updated by: EMD Serono Research & Development Institute, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
337

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Edegem, Belgium
        • UZ Antwerpen
      • Mons, Belgium, 7000
        • CHU Ambroise Pare
      • Mons, Belgium
        • CHU Ambroise Pare
      • Roeselare, Belgium, 8800
        • AZ Delta
      • Roeselare, Belgium
        • AZ Delta
  • China
      • Beijing, China
        • Beijing Hospital
      • Beijing, China
        • Peking University Cancer Hospital
      • Changchun, China
        • Jilin Cancer Hospital - Oncology
      • Changsha, China
        • Hunan Cancer Hospital
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Chengdu, China
        • Sichuan Cancer Hospital
      • Guangzhou, China
        • Guangdong General Hospital
      • Hangzhou, China
        • Zhejiang Cancer Hospita
      • Harbin, China
        • Affiliated Tumor Hospital of Harbin Medical University
      • Hefei, China
        • Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
      • Jinan, China
        • Jinan Central Hospital
      • Linyi, China
        • Linyi Tumor Hospital
      • Nanjing, China
        • Jiangsu Province Hospital
      • Shanghai, China
        • Shanghai Cancer Hospital, Fudan University
      • Shenyang, China
        • Liaoning Cancer Hospital & Institute
      • Ürümqi, China
        • The Affiliated Cancer Hospital of Xinjiang Medical University
  • France
      • Angers, France
        • ICO - Site Paul Papin
      • Bayonne, France
        • Centre Hospitalier de la Cote Basque
      • Cholet, France
        • Centre Hospitalier de Cholet
      • Créteil, France
        • Centre Hospitalier Intercommunal de Creteil
      • La Roche-sur-Yon, France
        • Centre Hospitalier Departemental Les Oudairies
      • Lille, France
        • Hopital Albert Calmette - CHU Lille
      • Lorient, France
        • Centre Hospitalier de Bretagne Sud
      • Paris, France
        • Hopital Saint-Louis
      • Pessac, France
        • Groupe Hospitalier Sud - Hôpital Haut-Lévêque
      • Saint-Herblain, France
        • ICO - Site René Gauducheau
      • Saint-Nazaire, France
        • Clinique Mutualiste de l'Estuaire
      • Toulouse, France
        • CHU de Toulouse - Hôpital Larrey
    • Gironde
      • Pessac, Gironde, France, 33604
        • Groupe Hospitalier Sud - Hôpital Haut-Lévêque
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • CHU de Toulouse - Hôpital Larrey
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44805
        • ICO - Site René Gauducheau
      • Saint-Nazaire, Loire Atlantique, France, 44606
        • Clinique Mutualiste de l'Estuaire
    • Maine Et Loire
      • Angers, Maine Et Loire, France, 49055
        • ICO - Site Paul Papin
      • Cholet, Maine Et Loire, France, 49300
        • Centre Hospitalier de Cholet
    • Morbihan
      • Lorient, Morbihan, France, 56322
        • Centre Hospitalier de Bretagne Sud
    • Nord
      • Lille, Nord, France, 59037
        • Hopital Albert Calmette - CHU Lille
    • Pyrenees Atlantiques
      • Bayonne, Pyrenees Atlantiques, France, 64100
        • Centre Hospitalier de la Cote Basque
    • Vendee
      • La Roche-sur-Yon, Vendee, France, 85925
        • Centre Hospitalier Departemental Les Oudairies
  • Germany
      • Berlin, Germany
        • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
      • Chemnitz, Germany
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Dresden, Germany
        • Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
      • Erfurt, Germany
        • HELIOS Klinikum Erfurt
      • Gauting, Germany
        • Asklepios Fachkliniken Muenchen-Gauting
      • Gera, Germany
        • SRH Wald-Klinikum Gera gGmbH
      • Göttingen, Germany
        • Universitaetsmedizin Goettingen
      • Hamm, Germany
        • Evangelisches Krankenhaus Hamm GmbH
      • Heidelberg, Germany
        • Universitaetsklinikum Heidelberg
      • Homburg / Saar, Germany
        • Universitaetsklinikum des Saarlandes
      • Leipzig, Germany
        • POIS Leipzig GbR
      • Mainz, Germany
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
      • Oldenburg, Germany
        • Pius-Hospital Oldenburg
    • Saxony
      • Leipzig, Saxony, Germany, 04357
        • POIS Leipzig GbR
  • Israel
      • Beersheba, Israel
        • Soroka University Medical Center
      • Jerusalem, Israel
        • Hadassah University Hospital - Ein Kerem
      • Kfar Saba, Israel
        • Meir Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center-Beilinson Campus
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Genova, Italy
        • Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy
        • IEO Istituto Europeo di Oncologia
      • Naples, Italy
        • Seconda Università degli Studi di Napoli
      • Padova, Italy
        • Azienda Ospedaliera di Padova
      • Padova, Italy
        • Iov - Istituto Oncologico Veneto Irccs
      • Padova, Italy
        • Ospedale Santa Maria di Cà Foncello
      • Roma, Italy
        • Azienda Ospedaliera San Camillo Forlanini
      • Roma, Italy
        • Universita Campus Bio-Medico di Roma
      • Rozzano, Italy
        • Istituto Clinico Humanitas
  • Japan
      • Fukuoka, Japan
        • NHO Kyushu Medical Center
      • Kashiwa-shi, Japan
        • National Cancer Center Hospital East
      • Kitaadachi-gun, Japan
        • Saitama Cancer Center
      • Kurume-shi, Japan
        • Kurume University Hospital
      • Matsuyama, Japan
        • NHO Shikoku Cancer Center
      • Nagoya, Japan
        • Nagoya University Hospital
      • Niigata, Japan
        • Niigata Cancer Center Hospital
      • Osaka, Japan
        • Osaka International Cancer Institute
      • Sakaishi, Japan
        • NHO Kinki-Chuo Chest Medical Center
      • Sapporo, Japan
        • Hokkaido University Hospital
      • Ube-shi, Japan
        • NHO Yamaguchi - Ube Medical Center
      • Yokohama, Japan
        • Kanagawa Cancer Center
      • Yonago-shi, Japan
        • Tottori University Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • VU Medisch Centrum
      • Amsterdam, Netherlands
        • Antoni van Leeuwenhoek Ziekenhuis
      • Groningen, Netherlands
        • Universitair Medisch Centrum Groningen (UMCG) - Parent
  • Poland
      • Bialystok, Poland
        • Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis
      • Bystra, Poland
        • Centrum Pulmonologii i Torakochirurgii w Bystrej
      • Lublin, Poland
        • Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
      • Olsztyn, Poland
        • NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
      • Poznan, Poland, 60-693
        • Przychodnia Med-Polonia Sp. z o.o.
      • Poznan, Poland
        • Przychodnia Med-Polonia Sp. z o.o.
      • Warsaw, Poland
        • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
      • Warsaw, Poland, 02-781
        • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • South Korea
      • Busan, South Korea
        • Kosin University Gospel Hospital
      • Busan, South Korea
        • Dong-A University Hospital
      • Daegu, South Korea
        • Kyungpook National University Medical Center
      • Goyang-si, South Korea
        • National Cancer Center
      • Hwasun-gun, South Korea
        • Chonnam National University Hwasun Hospital
      • Incheon, South Korea
        • Gachon University Gil Medical Center
      • Seongnam-si, South Korea
        • Seoul National University Bundang Hospital
      • Seoul, 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
      • Suwon, South Korea
        • The Catholic university of Korea, St. Vincent's Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital Universitari Quiron Dexeus
      • Barcelona, Spain
        • Hospital Universitari Sagrat Cor
      • Cartagena, Spain
        • Hospital General Universitario Santa Lucía
      • Jerez de la Frontera, Spain
        • Hospital de Especialidades de Jerez de la Frontera - Servicio de Oncologia
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Hospital Universitario Hm Madrid Sanchinarro
      • Madrid, Spain
        • Hospital Universitario Hm Madrid Sanchinarro
      • Málaga, Spain
        • Hospital Clínico Universitario Virgen de la Victoria
      • San Sebastián de los Reyes, Spain
        • Hospital Universitario Infanta Sofía
      • Sant Cugat del Vallès, Spain
        • Hospital General de Catalunya
      • Seville, Spain
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain
        • Hospital Universitario Nuestra Señora de Valme
  • Switzerland
      • Bern, Switzerland
        • Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie
      • Zurich, Switzerland
        • Universitaetsspital Zuerich - Klinik fuer Onkologie
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Cancer Center
      • Encinitas, California, United States, 92024
        • California Cancer Associates for Research & Excellence, Inc.
      • Orange, California, United States, 92868-4225
        • St. Joseph Hospital
      • Redondo Beach, California, United States, 90277
        • Torrance Health Association
      • Santa Rosa, California, United States, 95403
        • St Joseph Heritage Healthcare
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital Inc.
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute, Inc
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Harvey, Illinois, United States, 60426-3558
        • Ingalls Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Community Regional Cancer Care
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Massachusetts
      • Rockland, Massachusetts, United States
        • For Recruiting Locations in the United States, please Contact U.S. Medical Information
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • St. Louis Cancer Care, LLP
      • St Louis, Missouri, United States, 63110
        • Saint Louis University
      • St Louis, Missouri, United States, 63110
        • Saint Louis University Cancer Center
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Summit Medical Group
      • Berkeley Heights, New Jersey, United States, 07922
        • Summit Medical Group, P.A.
      • East Brunswick, New Jersey, United States, 08816
        • Regional Cancer Care Associates East Brunswick
      • East Brunswick, New Jersey, United States, 8816
        • Somerset Hematology Oncology Associates - Somerville Location
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center PARTNER
      • Midland Park, New Jersey, United States, 07432
        • Prospect Medical Offices, LLC
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center - Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion
      • New York, New York, United States, 10022
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • UC Health Clinical Trials Office
      • Cincinnati, Ohio, United States, 45267-0502
        • University of Cincinnati - PARENT
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology, P.A. - Austin
      • Beaumont, Texas, United States, 77702-1449
        • Texas Oncology, PA
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Medical Center Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
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.
Other: 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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
Time from first treatment up to data cutoff (approximately Month 66)
Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Time Frame: Time from first treatment up to data cutoff (approximately Month 66)
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.
Time from first treatment up to data cutoff (approximately Month 66)
Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Time Frame: Time from first treatment up to data cutoff (approximately Month 66)
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.
Time from first treatment up to data cutoff (approximately Month 66)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by IRC
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by Investigator
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Progression-free Survival by IRC Assessment
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B +C: Progression-free Survival by Investigator Assessment
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Overall Survival (OS)
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B +C: Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Number of Participants With Markedly Abnormal Vital Signs and Physical Examination
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
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)
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)
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)
Time Frame: Time from first treatment up to end of study (approximately Month 101)
Time from first treatment up to end of study (approximately Month 101)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EMD Serono Research & Development Institute, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck KGaA, Darmstadt, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Responsible, EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS200095-0022
  • 2015-005696-24 (EudraCT Number)
  • 2024-512003-39-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union

IPD Sharing Access Criteria

Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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