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REGN5093-M114 for Non-Small Cell Lung Cancer
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective. The treatment is an antibody drug conjugate called REGN5093-M114 and it is being tested on patients with a certain type of lung cancer. The study has two parts, or phases. The first phase is to see if the treatment is safe and to find the best dose. The second phase is to see if the treatment works against the cancer.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT03257267Trial Design
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- I haven't had any cancer treatment or been in a trial for at least 2 weeks.I do not have an active brain tumor or cancer spread to my brain or spinal cord.I am willing to provide a recent or new biopsy of my tumor for testing.I haven't had major surgery or radiation within the last 14 days and have recovered from any side effects.I do not have another cancer that is getting worse or needs treatment.I haven't had brain inflammation, serious brain disorders, or uncontrolled seizures in the last year.My lung cancer is at an advanced stage with no other beneficial treatments available.I have at least one tumor that can be measured and has grown after radiation.My tumor has high levels of MET protein.My organs and bone marrow are functioning well.I am fully active or restricted in physically strenuous activity but can do light work.I have mostly recovered from side effects of my previous treatments.I do not have an uncontrolled HIV, hepatitis B or C, or a diagnosed immunodeficiency.
- Group 1: Phase 2. Dose Expansion
- Group 2: Phase 1. Dose Escalation
- 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
From how many different places is this clinical trial being overseen?
"There are many hospitals enrolling patients in this clinical trial, such as John Hopkins in Baltimore, Henry Ford Hospital in Charleston, and Medical University of South carolina in New york. In total, there are 10 locations running this study."
What are researchers trying to find out by conducting this trial?
"The main goal of this clinical trial, which will take an average of 2 years to complete, is to monitor serious adverse events. Additionally, the study hopes to assess the duration of response in phase 1 and phase 2 patients as well as total monoclonal antibodies in serum (REGN5093-M114 plus unconjugated antibody) during dose expansion (phase 2). Another objective is to understand REGN5093-M114 concentrations in serum during dose expansion (Phase 2)."
Are we presently recruiting participants for this research project?
"Yes, the study is still recruiting patients. The listing on clinicaltrials.gov shows that it was first posted on November 9th 2021 and updated as recently as October 19th 2022. They are hoping to recruit 83 individuals from 10 different centres."
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What portion of applicants met pre-screening criteria?
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