This phase 2 clinical trial will test the effectiveness of poziotinib in treating locally advanced (spread to nearby tissue) or metastatic (spread to other parts of the body) non-small cell lung cancer (NSCLC) with an EGFR mutation. The primary outcome will be measured by the response rate to the treatment. This trial is being conducted in Houston, Texas.
The details
EGFR is a cellular protein that relays a signal for growth and division. Some forms of cancers have a mutations in the EGFR protein, which leads to uncontrolled growth of cells. Poziotinib is an inhibitor of the EGFR protein. It permanently blocks the growth signal in cancer cells that overexpress EGFR, which eventually leads to cell death. This therapy is a promising treatment for metastatic NSCLC since it targets cancer cells throughout the body.
This study will examine the effectivess and safety of posiotinib in EGFR-mutated NSCLC. The study will mainly examine the response rate to the treatment as well as adverse (negative) effects.
Who are they looking for?
This trial will recruit 30 patients with recurrent NSCLC that does not respond to other treatments or stage 4 for NSCLC with an EGFR mutation in exon 20 (determined by genetic testing). Participants of the trial must have shown disease progression during or after a platinum-based chemotherapy. Patients should also have adequate organ and bone marrow function and must agree to use birth control during the trial.
Participants cannot have gastrointestinal diseases, uncontrolled illnesses, brain metastasis, or history another primary malignancy within 5 years prior to enrollment. Patients must also have been out of surgery for 4 weeks and cannot receive any other treatment during the trial.
How will it work
Participants will take 2 poziotinibtablets by mouth once a day over a 28 day cycle. Treatment will continue as long as the doctor believes it is in the patient’s best interest.
