Lorlatinib Continuation Study

Other

• Female participants who are pregnant or breastfeeding.
• Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.

• Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.
• Participants must agree to follow the reproductive criteria as outlined in Appendix 3 (Section 10.3.1 for males and Section 10.3.2 for females).
• Adequate organ function as defined by the following criteria: • Hepatic function: Serum AST and serum ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN if liver function abnormalities were due to underlying malignancy; total serum bilirubin ≤1.5 × ULN (except participants with documented Gilbert’s syndrome); • Bone marrow function: absolute neutrophil count ≥1000/μL (1.0 x 109 /L or 1000/mm3), platelets ≥50,000/μL (50 x 109 /L or 50000/mm3); hemoglobin ≥8.0 g/dL; • Renal function: Serum creatinine ≤2.0 × ULN.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
• Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.