Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02864992

Run by

EMD Serono Research & Development Institute, Inc.

People needed

337

Starts

2016-09-13

Expected to finish

2026-08-31

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• St Joseph Heritage Healthcare — Santa Rosa, California, United States
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
• Holy Cross Hospital Inc. — Fort Lauderdale, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute, Inc — Tampa, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Ingalls Hospital — Harvey, Illinois, United States
• Community Regional Cancer Care — Indianapolis, Indiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, 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 — St Louis, Missouri, United States
• Saint Louis University — St Louis, Missouri, United States
• Summit Medical Group, P.A. — Berkeley Heights, 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
• Hackensack University Medical Center PARTNER — Hackensack, New Jersey, United States
• Prospect Medical Offices, LLC — Midland Park, New Jersey, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• City of Hope Cancer Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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