Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer Carrying an ALK or ROS1 Rearrangement

August 15, 2018
Pfizer EAP
Lung Cancer
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.

Sponsor: Pfizer

https://clinicaltrials.gov/ct2/show/NCT03178071

  • 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 atezolizumab).
  • Adequate bone marrow, liver, renal, and pancreatic function

Life-time

Accepting Participants
Interventional
Kathy Seymour, BSN
630-646-6075
630-646-6110
630-646-6072