Clinical trial NCT02864992: Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
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
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2016-08-12
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
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)
timeFrame: Time from first treatment up to data cutoff (approximately Month 66)
measure: Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
timeFrame: Time from first treatment up to data cutoff (approximately Month 66)
measure: Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
timeFrame: Time from first treatment up to data cutoff (approximately Month 66)
Secondary outcomes:
measure: 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
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by IRC
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by Investigator
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Progression-free Survival by IRC Assessment
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B +C: Progression-free Survival by Investigator Assessment
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Overall Survival (OS)
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B +C: Number of Participants With Markedly Abnormal Clinical Laboratory Tests
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Number of Participants With Markedly Abnormal Vital Signs and Physical Examination
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: 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)
timeFrame: Time from first treatment up to end of study (approximately Month 101)
measure: 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)
timeFrame: Time from first treatment up to end of study (approximately Month 101)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Cancer Center
state: California
city: Encinitas
country: United States
facility: California Cancer Associates for Research & Excellence, Inc.
state: California
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc.
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute, Inc
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Community Regional Cancer Care
state: Indiana
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Rockland
country: United States
facility: For Recruiting Locations in the United States, please Contact U.S. Medical Information
state: Massachusetts
city: Bridgeton
country: United States
facility: St. Louis Cancer Care, LLP
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Berkeley Heights
country: United States
facility: Summit Medical Group, P.A.
state: New Jersey
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: East Brunswick
country: United States
facility: Regional Cancer Care Associates East Brunswick
state: New Jersey
city: East Brunswick
country: United States
facility: Somerset Hematology Oncology Associates - Somerville Location
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center PARTNER
state: New Jersey
city: Midland Park
country: United States
facility: Prospect Medical Offices, LLC
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center - Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: UC Health Clinical Trials Office
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati - PARENT
state: Ohio
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, P.A. - Austin
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology, PA
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center Oncology
state: Washington
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Roeselare
country: Belgium
facility: AZ Delta
city: Roeselare
country: Belgium
facility: AZ Delta
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital - Oncology
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospita
city: Harbin
country: China
facility: Affiliated Tumor Hospital of Harbin Medical University
city: Hefei City
country: China
facility: Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
city: Jinan
country: China
facility: Jinan Central Hospital
city: Linyi
country: China
facility: Linyi Tumor Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Shanghai Cancer Hospital, Fudan University
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical university
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque
state: Gironde
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Larrey
state: Haute Garonne
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
state: Loire Atlantique
city: Saint Nazaire Cedex
country: France
facility: Clinique Mutualiste de l'Estuaire
state: Loire Atlantique
city: Angers Cedex 2
country: France
facility: ICO - Site Paul Papin
state: Maine Et Loire
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
state: Maine Et Loire
city: Lorient cedex
country: France
facility: Centre Hospitalier de Bretagne Sud
state: Morbihan
city: Lille Cedex
country: France
facility: Hopital Albert Calmette - CHU Lille
state: Nord
city: Bayonne
country: France
facility: Centre Hospitalier de la côte Basque
state: Pyrenees Atlantiques
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental Les Oudairies
state: Vendee
city: Angers Cedex 2
country: France
facility: ICO - Site Paul Papin
city: Bayonne
country: France
facility: Centre Hospitalier de la côte Basque
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Creteil cedex
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental Les Oudairies
city: Lille Cedex
country: France
facility: Hopital Albert Calmette - CHU Lille
city: Lorient cedex
country: France
facility: Centre Hospitalier de Bretagne Sud
city: Paris Cedex 10
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque
city: Saint Herblain
country: France
facility: ICO - Site René Gauducheau
city: Saint Nazaire Cedex
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: Leipzig
country: Germany
facility: POIS Leipzig GbR
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Darmstadt
country: Germany
facility: For Recruiting Locations outside US, please Contact Merck KGaA Communication Center
city: Dresden
country: Germany
facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera gGmbH
city: Goettingen
country: Germany
facility: Universitaetsmedizin Goettingen
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Homburg / Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes
city: Leipzig
country: Germany
facility: POIS Leipzig GbR
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Kfar- Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro di Genova
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Seconda Università degli Studi di Napoli
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS
city: Padova
country: Italy
facility: Ospedale Santa Maria di Cà Foncello
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Medical Center
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
city: Matsuyama-shi
country: Japan
facility: NHO Shikoku Cancer Center
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
city: Sakai-shi
country: Japan
facility: NHO Kinki-Chuo Chest Medical Center
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Ube-shi
country: Japan
facility: NHO Yamaguchi - Ube Medical Center
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
city: Yonago-shi
country: Japan
facility: Tottori University Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek Ziekenhuis
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen (UMCG) - Parent
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis
city: Bystra
country: Poland
facility: Centrum Pulmonologii i Torakochirurgii w Bystrej
city: Lublin
country: Poland
facility: Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
city: Olsztyn
country: Poland
facility: NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
city: Poznan
country: Poland
facility: Przychodnia Med-Polonia Sp. z o.o.
city: Poznan
country: Poland
facility: Przychodnia Med-Polonia Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitari Sagrat Cor
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Lucia
city: Jerez de la Frontera
country: Spain
facility: Hospital de Especialidades de Jerez de la Frontera - Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario HM Madrid Sanchinarro
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Madrid Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofia
city: Sant Cugat del Valles
country: Spain
facility: Hospital General de Catalunya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich - Klinik fuer Onkologie
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.