Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

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