Loading clinical trials...

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

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)

NCT02864992•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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)
+9 more criteria

Locations (176)

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

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

Key Dates

Start Date

September 13, 2016

Primary Completion Date

May 16, 2022

Completion Date

April 30, 2026

Last Updated

December 23, 2025

Enrollment

337

ACTUAL participants

Conditions

Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET AmplificationLung Adenocarcinoma Stage IIIB/IV

Interventions

Tepotinib

DRUG