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

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