This trial is evaluating the safety and effectiveness of experimental treatment REGN5093 in patients with advanced non-small-cell lung cancer (NSCLC). The main outcomes to be evaluated will be the number of patients who experience side effects, the maximum dose without significant side effects, and response to treatment. This trial is recruiting in the United States and Korea.
The details
NSCLC accounts for approximately 85% of all lung cancers. Advanced NSCLC has spread away from the original tumor and is difficult to treat. Some NCSLCs have on cancer cells an abnormal protein called c-Met. This protein normally leads to organ development and wound healing. When gene abnormalities (mutations) occur in the MET gene, c-Met becomes over-expressed and leads to abnormal tissue growth. NSCLCs having c-MET abnormalities are difficult to treat.
REGN5093 is an experimental drug that blocks the action of abnormal MET genes. Therefore, tumors with abnormalities in the MET gene stop growing. This trial is evaluating the safety and effectiveness of REGN5093 in patients with advanced NSCLC and MET abnormalities. The main outcomes to be measured will be the number of patients who have side effects, the maximum dose with tolerable side effects, and tumor response.
Who are they looking for?
This trial is looking to recruit 102 participants with advanced NSCLC. Participants must have exhausted all treatment options, must have an old tumor tissue, and be willing to have a new tumor tissue (biopsy) taken.
Participants must not have received anti-cancer treatment within 3 weeks from this trial or have any remaining side effects from cancer therapy. Patients who received major surgery or radiation therapy within 14 days of this trial will also be excluded. Allergy to antibiotics such as doxycycline or tetracycline and brain metastases will exclude participants from the study.
How will it work
All participants will receive REGN5093 as an intravenous (IV; into the vein) infusion. In the beginning, the drug will be given in increasing doses to test the maximum dose with acceptable side effects.
Participants will be followed up for up to 4 years and side effects and response to treatment will be evaluated.
