This phase 2 trial will clinical trial will test the effectiveness of lorlatinib in treating non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) mutations. The primary outcome will be measured by the rate at which the disease spreads to the central nervous system (CNS).
The details
Some NSCLC are associated with genetic changes in the ROS1 and ALK genes, which code for cellular proteins that induce cell growth. When mutated, these proteins can cause uncontrolled growth and lead to cancer. Lorlatinib works to inhibit these mutated proteins in tumors and prevent the growth and division of cancer cells. It also has the ability to cross the blood brain barrier, unlike most chemotherapies, and kill cancer cells that have spread to the brain. Lorlatinib is a promising treatment for ALK and ROS1 positive NSCLC where preventing disease progression has been a challenge.
The study will examine response rate of the disease in the central nervous system over 12 weeks as well as the time to disease progression up to 2 years.
Who are they looking for?
This trial will recruit 30 patients with advanced NSCLC with ALK or ROS1 rearrangements that has metastasized (spread) to the CNS. Patients must have either had no prior treatment for the advanced stage of the disease or showed disease progression or intolerance to an inhibitor of ALK or ROS1. Participants must have adequate organ function and women of childbearing potential must use two forms of birth control.
Participants cannot receive radiation therapy within 7 days of entry and must have completed systemic anticancer therapy for a minimum of 5 half-lives. Patients also cannot have an active viral, fungal, or bacterial infection upon entry.
How will it work
Patients will take loratinibby mouth once a day throughout a 21 day cycle. Blood samples will be collected to determine whether the treatment is effective in controlling the disease.
