Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
NCT02864992 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 337
Last updated 2026-04-13
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.
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
- 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.
Sponsors & Collaborators
-
Merck KGaA, Darmstadt, Germany
collaborator INDUSTRY -
EMD Serono Research & Development Institute, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Responsible · EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-13
- Primary Completion
- 2022-05-16
- Completion
- 2026-04-30
Countries
- United States
- Austria
- Belgium
- China
- France
- Germany
- Israel
- Italy
- Japan
- Netherlands
- Poland
- South Korea
- Spain
- Switzerland
- Taiwan
Study Locations
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