This phase 2 clinical trial will test the effectiveness of merestinib in non-small cell lung cancer patients with a mutation in the MET protein. The primary outcome will be measured by the overall response to the treatment. This study is being conducted in Boston, Massachusetts.
The details
Merestinib is an inhibitor of the C-Met pathway, which normally signals cell growth and division. Some cancers have mutations in the MET protein, which causes the C-Met pathway to be overactive in tumors. Merestinib is able to stop growth and possibly induce death in cancer cells with this mutation throughout the body.
This trial will examine the safety and effectiveness of merestinib in NSCLC. The main outcomes to be measured include the response rate, duration of response, side effects, and survival rate up to 2 years.
Who are they looking for?
This study will recruit 25 patients with NSCLC and a MET mutation at exon 14 or an advanced solid tumor with a NTRK1, 2, or 3 mutation. All patients must have received at least one prior treatment for metastasis (spread of cancer). Participants must have adequate organ and bone marrow function and must agree to a form a birth control during the study.
Patients cannot have received chemotherapy, investigational therapy, major surgery, or radiotherapy 3 weeks prior to enrollment. Participants cannot have brain metastasis, an ongoing infection, uncontrolled heart disease, HIV, uncontrolled hypertension, significant gastrointestinal abnormalities, or a history of another cancer.
How will it work
Patients will be separated into two groups. One group will consist of individuals with NSCLC who have a MET mutation at exon 14, the other group will consist of individuals who have a solid tumor with an NTRK rearrangement. Both groups will receive daily doses of merestinib by mouth over 28 day cycles.
Response rates and survival will be measured over 2 years.
