Phase II Study of Tepotinib for Lung Cancer with MET Changes (VISION)
Sponsor: EMD Serono Research & Development Institute, Inc.
ClinicalTrials ID:NCT02864992
This clinical trial is testing the effectiveness of the drug tepotinib in stopping the growth and spread of lung cancer with specific MET gene changes. The study also looks at the safety of the drug, its side effects, and how it affects patients' quality of life. An optional part of the study explores how genetics might influence the drug's effectiveness.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to see how well tepotinib works in treating lung cancer that has specific changes in the MET gene. It also examines the safety of the drug, its side effects, and how it affects patients' quality of life. Additionally, there is an optional part of the study that looks at how a person's genes might affect how well the drug works.
Description
The study is divided into three groups, each focusing on a main goal: the Objective Response Rate, which measures how well the cancer responds to the treatment. The number of participants and the completion date may change as new groups are added.
Eligibility Criteria
Inclusion Criteria
- Must provide signed, written consent to participate.
- Must be 18 years or older.
- Must have measurable lung cancer as confirmed by a review committee.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Women must not be pregnant or breastfeeding and must agree to use effective birth control if of childbearing potential.
- Men must agree to use effective birth control if their partners are of childbearing potential.
- Must have advanced non-small cell lung cancer (NSCLC) confirmed by lab tests.
- Must have specific MET gene changes as confirmed by lab tests.
- Must not have had more than two previous treatments for cancer.
Exclusion Criteria
- Cannot have certain gene changes that make other treatments more effective.
- Cannot have unstable brain cancer.
- Cannot have unresolved severe side effects from previous cancer treatments.
- Cannot have needed a blood transfusion within 14 days before starting the trial.
- Cannot have had recent cancer treatments within 21 days before starting the trial.
- Cannot have brain cancer as the only measurable cancer.
- Must have adequate blood, liver, kidney, and heart function.
- Cannot have had previous treatments targeting the MET pathway.
- Cannot have uncontrolled high blood pressure.
- Cannot have had other cancers unless treated and cancer-free for at least 5 years.
- Cannot have conditions affecting digestion or absorption of the drug.
- Cannot have had major surgery within 28 days before starting the trial.
- Cannot have certain infections like HIV or active hepatitis.
- Cannot have substance abuse issues or other serious medical or psychiatric conditions.
- Cannot have allergies to the trial drug ingredients.
- Cannot have legal or mental incapacity.
- Cannot have participated in another clinical trial within the past 30 days.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Cancer Center | 91010 | Duarte | California |
| California Cancer Associates for Research & Excellence, Inc. | 92024 | Encinitas | California |
| St. Joseph Hospital | 92868-4225 | Orange | California |
| Torrance Health Association | 90277 | Redondo Beach | California |
| St Joseph Heritage Healthcare | 95403 | Santa Rosa | California |
| Rocky Mountain Cancer Centers, LLP | 80218 | Denver | Colorado |
| Holy Cross Hospital Inc. | 33308 | Fort Lauderdale | Florida |
| H. Lee Moffitt Cancer Center and Research Institute, Inc | 33612-9497 | Tampa | Florida |
| University Cancer & Blood Center, LLC | 30607 | Athens | Georgia |
| Winship Cancer Institute | 30322 | Atlanta | Georgia |
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