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Tepotinib for Non-Small Cell Lung Cancer
Study Summary
This trial will study the effects of tepotinib on patients with lung cancer that has spread to the brain. It will also look at tepotinib in combination with other drugs for patients who have developed resistance to their current treatment.
- Advanced Non-Small Cell Lung Cancer With MET Mutations
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 1 & 2 trial • 66 Patients • NCT02115373Trial Design
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Who is running the clinical trial?
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- You are expected to live for at least 12 weeks.You have severe heart failure classified as Class III or IV by the New York Association.You have high blood pressure that is not well managed with medication.You have had a serious allergic reaction to any of the treatment components used in the study.Your brain scans must show certain conditions before you can participate in the study's brain expansion group.You have a history of significant bowel obstruction, malabsorption syndromes or other gastrointestinal disorders.You have taken part in another clinical trial or received an experimental drug within the last 28 days.
- Group 1: Combination Therapy
- Group 2: Monotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research being conducted for the first time?
"Tepotinib has been under clinical evaluation since 2016 when the first trial, sponsored by Merck KGaA, Darmstadt, Germany was completed. That initial study only included 337 participants. However, Tepotinib received Phase 2 approval after the data from that first 2016 study was analyzed. As of now, there are 5 active trials being conducted in 74 cities and 21 countries."
How many study subjects are enrolling in this research project?
"The sponsor, Criterium, Inc., needs to enroll 65 patients that meet the study's inclusion criteria in order to begin. The trial will be conducted at Georgetown Lombardi Comprehensive Cancer Center and University of Colorado Cancer Center."
Is this the first time Tepotinib has been trialed?
"Tepotinib's first clinical trial was in 2016 at Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis. To date, there have been 12 completed studies and 5 ongoing trials. The majority of these are taking place within Washington D.C.."
At how many different sites is this clinical trial being conducted?
"Georgetown Lombardi Comprehensive Cancer Center in Washington, University of Colorado Cancer Center in Aurora, and University of Washington in Seattle are 3 of the 4 main locations running this trial."
What are the main goals of this clinical trial?
"The aim of this long-term study is to monitor and record the Dose Limiting Toxicity (DLT) in patients that receive monotherapy. Additionally, researchers will keep track of secondary outcomes like frequency of adverse events, blood PK parameters, and graded drug-related AEs in the central nervous system efficacy evaluation cohort."
Are they currently looking for new participants in this clinical trial?
"Yes, this trial is still open and recruiting patients. The initial posting was on May 25th, 2022 with the most recent edit happening on October 14th of the same year. They are hoping to enroll 65 people in total from 4 different hospital sites."
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