Lorlatinib Continuation Study
Sponsor: Pfizer
ClinicalTrials ID:NCT05144997
This study ensures continued access to lorlatinib for participants benefiting from previous Pfizer trials. Eligible individuals must show clinical benefit, adhere to reproductive criteria, and have adequate bone marrow, liver, renal, and pancreatic function. Lorlatinib, an ALK-positive NSCLC treatment, will be administered with ongoing safety monitoring.
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Program Overview
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention
Eligibility Criteria
Inclusion Criteria
1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.
2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function
Exclusion Criteria
1 - Female participants who are pregnant or breastfeeding. 2- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
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