Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
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
Given that an Expanded Access study does not meet the definition of a controlled clinical
 investigation, and as such, is not considered an applicable drug clinical trial per NIH,
 Basic Results for such studies are not required to be reported. Protocol B7461020 has been
 identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov,
 however Basic Results will not be posted. This statement has been placed in the Detailed
 Description section of the protocol registration on ClinicalTrials.gov.
Inclusion Criteria:

 -  Ineligibility for participation in any ongoing clinical study of the investigational
 product

 -  Age ≥18 years

 -  Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK
 rearrangement or a ROS1 rearrangement

 -  For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If
 prior ALK-TKI was crizotinib, additional prior treatment required with at least one
 second generation ALK-TKI registered and commercially available. For patients with
 resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance
 mutation), prior treatment with an ALK/ROS1 inhibitor is not required.

 -  For ROS1 positive patients: failure to prior treatment with at least crizotinib

 -  Adequate bone marrow, liver, renal, pancreatic functions

 -  Negative pregnancy test at screening

 Exclusion Criteria:

 -  Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or
 participation in other studies with investigational drugs within the timeframe
 indicated in the protocol

 -  History of interstitial fibrosis or interstitial lung disease

 -  Concomitant use of prohibited medication

 -  Clinically significant cardiovascular disease: cerebral vascular accident/stroke,
 myocardial infarction, unstable angina, congestive heart failure, second degree or
 third degree atrioventricular block (unless paced) or any AV block with PR >220 msec

 -  Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with
 QTc >470 msec, or congenital long QT syndrome

 -  History of or predisposing characteristics for acute pancreatitis