Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer Carrying an ALK or ROS1 Rearrangement
August 15, 2018
Maria Quejada, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib.
- Metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement as determined by an approved test or a ROS1 rearrangement.
- Documented treatment failure (ie, disease progression or intolerance to therapy) of
all locally approved ALK/ROS1 inhibitor therapies with the exception of patients
with documented resistance mutations not covered by other inhibitors (eg, ALK
G1202R resistance mutation), for whom prior treatment with an ALK/ROS1 inhibitor
is not required.
- Documented treatment failure (ie, disease progression or intolerance to therapy) of at
least one approved chemotherapy regimen (eg, a platinum-based doublet or a taxane)
or at least one approved immunotherapy agent (eg, pembrolizumab, nivolumab, or
- Adequate bone marrow, liver, renal, and pancreatic function
Kathy Seymour, BSN