MedPath

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Phase 2
Active, not recruiting
Conditions
Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification
Lung Adenocarcinoma Stage IIIB/IV
Interventions
Registration Number
NCT02864992
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Brief 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. 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.

Detailed Description

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

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
337
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Part 1: Cohort A: METex14 Skipping AlterationsTepotinibParticipants 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.
Part 1: Cohort B: MET AmplificationTepotinibParticipants 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.
Part 2: Cohort C: Confirmatory Part for METex14 Skipping AlterationsTepotinibParticipants 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.
Primary Outcome Measures
NameTimeMethod
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 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.

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 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.

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 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.

Secondary Outcome Measures
NameTimeMethod
Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by InvestigatorTime from first treatment up to end of study (approximately Month 101)
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 InvestigatorTime from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by InvestigatorTime from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B +C: Progression-free Survival by Investigator AssessmentTime 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 DeathTime 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 TestsTime from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by IRCTime from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Progression-free Survival by IRC AssessmentTime from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Overall Survival (OS)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 ExaminationTime 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 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 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 ScoreTime 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 from first treatment up to end of study (approximately Month 101)

Trial Locations

Locations (157)

Holy Cross Hospital Inc.

🇺🇸

Fort Lauderdale, Florida, United States

Virginia Cancer Specialists, PC

🇺🇸

Fairfax, Virginia, United States

Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson

🇺🇸

Wenatchee, Washington, United States

Wenatchee Valley Medical Center Oncology

🇺🇸

Wenatchee, Washington, United States

University of Chicago Medical Center

🇺🇸

Chicago, Illinois, United States

Swedish Medical Center

🇺🇸

Seattle, Washington, United States

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

Winship Cancer Institute

🇺🇸

Atlanta, Georgia, United States

University Cancer & Blood Center, LLC

🇺🇸

Athens, Georgia, United States

Ingalls Hospital

🇺🇸

Harvey, Illinois, 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

🇺🇸

Saint Louis, Missouri, United States

Summit Medical Group, P.A.

🇺🇸

Berkeley Heights, New Jersey, United States

Hackensack University Medical Center PARTNER

🇺🇸

Hackensack, 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

Prospect Medical Offices, LLC

🇺🇸

Midland Park, New Jersey, United States

The Valley Hospital

🇺🇸

Ridgewood, New Jersey, United States

Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion

🇺🇸

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center - Commack

🇺🇸

Commack, New York, United States

Texas Oncology, P.A. - Austin

🇺🇸

Austin, Texas, United States

Texas Oncology, PA

🇺🇸

Beaumont, Texas, United States

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

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

🇦🇹

Salzburg, Austria

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

UZ Antwerpen

🇧🇪

Edegem, Belgium

CHU Ambroise Paré

🇧🇪

Mons, Belgium

AZ Delta

🇧🇪

Roeselare, Belgium

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 City, China

Jinan Central Hospital

🇨🇳

Jinan, China

Linyi Tumor Hospital

🇨🇳

Linyi, China

Shanghai Cancer Hospital, Fudan University

🇨🇳

Shanghai, China

Liaoning Cancer Hospital & Institute

🇨🇳

Shenyang, China

The Affiliated Cancer Hospital of Xinjiang Medical university

🇨🇳

Urumqi, China

CHU de Toulouse - Hôpital Larrey

🇫🇷

Toulouse, France

ICO - Site René Gauducheau

🇫🇷

Saint Herblain, France

Groupe Hospitalier Sud - Hôpital Haut-Lévêque

🇫🇷

Pessac, France

Clinique Mutualiste de l'Estuaire

🇫🇷

Saint Nazaire Cedex, France

ICO - Site Paul Papin

🇫🇷

Angers Cedex 2, France

Centre Hospitalier de Cholet

🇫🇷

Cholet, France

Centre Hospitalier de Bretagne Sud

🇫🇷

Lorient cedex, France

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

🇩🇪

Berlin, Germany

Hopital Albert Calmette - CHU Lille

🇫🇷

Lille Cedex, France

Centre Hospitalier de la côte Basque

🇫🇷

Bayonne, France

Centre Hospitalier Départemental Les Oudairies

🇫🇷

La Roche sur Yon, France

Centre Hospitalier Intercommunal de Créteil

🇫🇷

Creteil cedex, France

Hôpital Saint-Louis

🇫🇷

Paris Cedex 10, France

POIS Leipzig GbR

🇩🇪

Leipzig, Germany

Klinikum Chemnitz gGmbH

🇩🇪

Chemnitz, Germany

For Recruiting Locations outside US, please Contact Merck KGaA Communication Center

🇩🇪

Darmstadt, Germany

Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

🇩🇪

Dresden, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

🇩🇪

Dresden, Germany

Helios Klinikum Erfurt

🇩🇪

Erfurt, Germany

Universitaetsmedizin Goettingen

🇩🇪

Goettingen, Germany

Asklepios Fachkliniken Muenchen-Gauting

🇩🇪

Gauting, Germany

SRH Wald-Klinikum Gera gGmbH

🇩🇪

Gera, Germany

Evangelisches Krankenhaus Hamm GmbH

🇩🇪

Hamm, Germany

Universitaetsklinikum Heidelberg

🇩🇪

Heidelberg, Germany

Universitaetsklinikum des Saarlandes

🇩🇪

Homburg / Saar, Germany

Soroka University Medical Center

🇮🇱

Beer-Sheva, Israel

Hadassah University Hospital - Ein Kerem

🇮🇱

Jerusalem, Israel

Meir Medical Center

🇮🇱

Kfar- Saba, Israel

Rabin Medical Center-Beilinson Campus

🇮🇱

Petach Tikva, Israel

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

🇩🇪

Mainz, Germany

Pius-Hospital Oldenburg

🇩🇪

Oldenburg, Germany

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

🇮🇹

Milano, Italy

IEO Istituto Europeo di Oncologia

🇮🇹

Milano, Italy

Seconda Università degli Studi di Napoli

🇮🇹

Napoli, Italy

Azienda Ospedaliera San Camillo Forlanini

🇮🇹

Roma, Italy

Università Campus Bio-Medico di Roma

🇮🇹

Roma, Italy

IOV - Istituto Oncologico Veneto IRCCS

🇮🇹

Padova, Italy

Azienda Ospedaliera di Padova

🇮🇹

Padova, Italy

Ospedale Santa Maria di Cà Foncello

🇮🇹

Padova, Italy

Istituto Clinico Humanitas

🇮🇹

Rozzano, Italy

National Cancer Center Hospital East

🇯🇵

Kashiwa-shi, Japan

NHO Kyushu Medical Center

🇯🇵

Fukuoka-shi, Japan

Nagoya University Hospital

🇯🇵

Nagoya-shi, Japan

Saitama Cancer Center

🇯🇵

Kitaadachi-gun, Japan

Kurume University Hospital

🇯🇵

Kurume-shi, Japan

NHO Shikoku Cancer Center

🇯🇵

Matsuyama-shi, Japan

Niigata Cancer Center Hospital

🇯🇵

Niigata-shi, Japan

Osaka International Cancer Institute

🇯🇵

Osaka-shi, Japan

NHO Kinki-Chuo Chest Medical Center

🇯🇵

Sakai-shi, Japan

Hokkaido University Hospital

🇯🇵

Sapporo-shi, Japan

NHO Yamaguchi - Ube Medical Center

🇯🇵

Ube-shi, Japan

Kanagawa Cancer Center

🇯🇵

Yokohama-shi, Japan

Tottori University Hospital

🇯🇵

Yonago-shi, Japan

Dong-A University Hospital

🇰🇷

Busan, Korea, Republic of

Kosin University Gospel Hospital

🇰🇷

Busan, Korea, Republic of

Kyungpook National University Medical Center

🇰🇷

Daegu, Korea, Republic of

National Cancer Center

🇰🇷

Goyang-si, Korea, Republic of

Chonnam National University Hwasun Hospital

🇰🇷

Hwasun-gun, Korea, Republic of

Gachon University Gil Medical Center

🇰🇷

Incheon, Korea, Republic of

Korea University Anam Hospital

🇰🇷

Seoul, Korea, Republic of

Seoul National University Bundang Hospital

🇰🇷

Seongnam-si, Korea, Republic of

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

🇰🇷

Seoul, Korea, Republic of

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

🇰🇷

Suwon-si, Korea, Republic of

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

Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska

🇵🇱

Lublin, Poland

Centrum Pulmonologii i Torakochirurgii w Bystrej

🇵🇱

Bystra, Poland

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

🇵🇱

Olsztyn, Poland

Przychodnia Med-Polonia Sp. z o.o.

🇵🇱

Poznan, Poland

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

🇵🇱

Warszawa, Poland

Hospital Universitari Vall d'Hebron

🇪🇸

Barcelona, Spain

Hospital Universitari Quiron Dexeus

🇪🇸

Barcelona, Spain

Hospital Universitari Sagrat Cor

🇪🇸

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 General Universitario Gregorio Marañon

🇪🇸

Madrid, Spain

Hospital Clinico Universitario Virgen de la Victoria

🇪🇸

Malaga, Spain

Hospital Universitario Infanta Sofia

🇪🇸

San Sebastian de los Reyes, Spain

Hospital General de Catalunya

🇪🇸

Sant Cugat del Valles, Spain

Hospital Universitario Nuestra Señora de Valme

🇪🇸

Sevilla, Spain

Hospital Universitario Virgen Macarena

🇪🇸

Sevilla, Spain

Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie

🇨🇭

Bern, Switzerland

Universitaetsspital Zuerich - Klinik fuer Onkologie

🇨🇭

Zuerich, Switzerland

Kaohsiung Chang Gung Memorial Hospital

🇨🇳

Kaohsiung, Taiwan

China Medical University Hospital

🇨🇳

Taichung, Taiwan

Taichung Veterans General Hospital

🇨🇳

Taichung, Taiwan

Taipei Veterans General Hospital

🇨🇳

Taipei, Taiwan

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

Tri-Service General Hospital

🇨🇳

Taipei, Taiwan

Hospital Universitario HM Madrid Sanchinarro

🇪🇸

Madrid, Spain

Hospital Universitario 12 de Octubre

🇪🇸

Madrid, Spain

Hospital Universitario La Paz

🇪🇸

Madrid, Spain

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Severance Hospital, Yonsei University

🇰🇷

Seoul, Korea, Republic of

University of Texas MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

UC Health Clinical Trials Office

🇺🇸

Cincinnati, Ohio, United States

University of Cincinnati - PARENT

🇺🇸

Cincinnati, Ohio, United States

Rocky Mountain Cancer Centers, LLP

🇺🇸

Denver, Colorado, United States

Community Regional Cancer Care

🇺🇸

Indianapolis, Indiana, United States

Tennessee Oncology

🇺🇸

Nashville, Tennessee, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

H. Lee Moffitt Cancer Center and Research Institute, Inc

🇺🇸

Tampa, Florida, United States

Center for Cancer and Blood Disorders

🇺🇸

Bethesda, Maryland, United States

St Joseph Heritage Healthcare

🇺🇸

Santa Rosa, California, United States

Saint Louis University

🇺🇸

Saint Louis, Missouri, United States

Jiangsu Province Hospital

🇨🇳

Nanjing, China

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