Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer Carrying an ALK or ROS1 Rearrangement
Active Date:
August 15, 2018
IRB Number:
Pfizer EAP
Condition/Disease:
Lung Cancer
Lead Researcher:
Maria Quejada, MD
Location:
Edward Cancer Center - Naperville
Purpose:
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
Eligibility:
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
Time Commitment:
Life-time
Status:
Accepting Participants
Current Trial Type:
Interventional
Contact Name:
Kathy Seymour, BSN
Phone:
630-646-6075
Fax:
630-646-6110
Alternate Phone:
630-646-6072